Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical
Phase: NA
Conditions: Elective Reconstructive Surgery Population
Sponsor: Shriners Hospitals for Children

 
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Study Protocol with SAP 
Study Title: Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, 
Satisfaction and Cost of Care in Surgical Patients 
Brief Title: The Effect of Healing Touch on Sleep (Sleep 7) 
NCT01870076 
Protocol ID 2015-1253 
Document Date: 10-19-2015 

 
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TITLE: Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, 
Satisfaction and Cost of Care in Surgical Patients 
 
Principal Investigator: 
 
Michele Gottschlich PhD, RD, CSP 
Shriners Hospitals for Children 
3229 Burnet Ave 
Cincinnati, OH 45229 
513-872-6298 (office) 
513-872-6361 (fax) 
mgottschlich@shrinenet.org 
 
 
Medical Staff Co-Investigator: 
Dr. John McCall M.D. 
  
 
Sponsor: 
Shriners Hospitals for Children 
International Headquarters 
2900 Rocky Point Drive 
Tampa, Florida 33607 
(813) 281-0300 
 
Protocol Number: 
CCHMC IRB # 2015-1253 
 
 
 
 
 
                                                                                                         Initial version: 4-1-2015 (v0) 
 
 
 
 
 
 
 
     Amended: 6-3-2015 (v1) 
 
 
 
 
 
 
 
       Amended: 8-28-2015 (v2) 
                                                                                                          Amended:10-19-2015 (v2.1) 
 

 
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List of Abbreviations 
 
 
Adverse Event 
 
 
 
 
 
 
 
AE 
American Academy Sleep Medicine  
 
 
 
 
AASM 
Analysis of Variance  
 
 
 
 
 
 
ANOVA 
Area under the Curve  
 
 
 
 
 
 
AUC 
Case Report Form 
 
 
 
 
 
 
 
CRF 
 
 
 
Center for Clinical and Translational Science and Training  
 
CCTST 
Cincinnati Children’s Hospital Medical Center 
 
 
 
CCHMC 
Complementary and Alternative Medicine 
 
 
 
 
CAM 
Common Terminology Criteria for Adverse Events  
 
 
CTCAE 
Cost-to-Charge Ratio                                                                                    CCR 
C - reactive protein 
 
 
 
 
 
 
 
CRP 
Dehydroepiandrosterone 
 
 
 
 
 
 
DHEA 
Electroencephalography 
 
 
 
 
 
 
EEG 
Electromyogram 
 
 
 
 
 
 
 
EMG 
Electronic Medical Record 
 
 
 
 
 
 
EMR 
Electrooculogram 
 
 
 
 
 
 
 
EOG 
Food and Drug Administration 
 
 
 
 
 
FDA 
Fast Fourier Transform 
 
 
 
 
 
 
FFT 
Generalizing Estimating Equations  
 
 
 
 
GEE 
Healing Touch 
 
 
 
 
 
 
 
HT 
Health Insurance Portability and Accountability Act  
 
 
HIPAA 
Institutional Review Board 
 
 
 
 
 
 
IRB 

 
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Intensive Care Unit 
 
 
 
 
 
 
 
ICU 
Intravenous 
 
 
 
 
 
 
 
 
IV 
Multiple Imputation 
 
 
 
 
 
 
 
MI 
National Cancer Institute 
 
 
 
 
 
 
NCI 
National Center for Complementary and Alternative Medicine 
 
NCCAM 
Observational Pain Assessment Scale 
 
 
 
 
OPAS 
Pharmacodynamics  
 
 
 
 
 
 
PD 
Pharmacokinetics 
 
 
 
 
 
 
 
PK 
Polysomnography 
 
 
 
 
 
 
 
PSG 
Post Anesthesia Recovery Unit 
 
 
 
 
 
PACU 
Principal Investigator  
 
 
 
 
 
 
PI 
Private Health Information  
 
 
 
 
 
 
PHI 
Rapid Eye Movement  
 
 
 
 
 
 
REM 
Same Day Surgery 
 
 
 
 
 
 
 
SDS 
Shriners Hospitals for Children 
 
 
 
 
 
SHC 
Standard Operating Procedure 
 
 
 
 
 
SOP 
Statistical Analysis Software  
 
 
 
 
 
SAS 
Total Sleep Time 
 
 
 
 
 
 
 
TST 
Wake After Sleep Onset 
 
 
 
 
 
 
WASO 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
 
  
Study Summary  
 
 
 
Study Schema 
 
 
1.0 
Introduction 
 
 
2.0 
Objectives 
 
 
3.0 
Subject Selection 
 
 
4.0 
Study Design  
 
 
5.0 
Subject Safety 
 
 
6.0 
Data Handling and Record Keeping  
 
 
7.0 
Quality Control and Quality Assurance  
 
 
8.0 
Statistical Considerations 
 
 
9.0 
Study Finance 
 
 
10.0 
References 
 
 
 

 
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STUDY SUMMARY  
 
Title 
The Effectiveness of Healing Touch on Sleep, Pain, Anxiety, 
Anesthesia Emergence, Satisfaction and Cost of Care  
Population: 
5-25 years; admitted for an elective surgery procedure 
Number of Subjects 
200  
Study Duration 
Study duration is from approximately 9 pm (when the electrodes are 
applied for the sleep test) the evening prior to surgery through no more 
than 8 hours after surgery the following day. 
Study site(s) 
Shriners Hospital for Children, Cincinnati  
Objectives 
We hope to learn the following: 
 
Determine if Healing Touch improves the quality and 
quantity of patient sleep the night before surgery  
 
Define any side effects associated with Healing Touch 
 
Establish the value of Healing Touch on the patient’s 
pain, stress, anxiety and recovery from anesthesia. 
 
Determine if Healing Touch is associated with measures 
of patient satisfaction and cost of care. 
Statistical 
Methodology 
Bivariate comparisons will be used to evaluate differences in baseline 
variables between Healing Touch and control groups (ex. age, gender 
and race, also type of surgical procedure e.g. burn versus other 
reconstructive procedure). These latter variables are potential 
covariates for secondary analysis. Analysis of variance (ANOVA) or 
Kruskal-Wallis test and Chi-square analysis will be used for these 
comparisons. Similarly, the association between outcome variables and 
baseline variables will be examined; correlation and ANOVA or Kruskal-
Wallis will be used as appropriate. 
 
 

 
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1.0           Introduction  
 
1.1 Background 
Tension between art and science is fueling insurgency against mainstream medicine 
as the general public, patients, caregivers and health care professionals alike are 
integrating complementary and alternative medicine (CAM) into wellness routines and 
treatment practices with increased frequency.1  From acupuncture to zinc, the portfolio 
of CAM options is blossoming as evidenced by the formation of the National Center 
for Complementary and Integrative Health (NCCIH) within the National Institutes of 
Health (NIH).2  Energy medicine is one of five domains of CAM recognized by 
NCCAM.3  It is based on the concept that there is universal energy, the human 
energy field is subject to imbalances, and a therapist can re-pattern the disrupted 
field by using compassionate intent to channel healing energy into a person to 
improve health.  
 
Energy-derived healing such as healing touch (HT) is based on principles of 
quantum physics that humans are energetic organisms that occupy a physical 
space.4  We create heat, generate electricity and even have a measurable 
magnetic field. Many integrative medicine practitioners believe that we have 
specific energy vortices that control the flow of subtle energy in the body (referred 
to as chakras) and that energy travels through the body along vertical pathways 
called meridians. Layers of energy within and surrounding the body are important 
for health and well-being. Disease and injury are believed to be related to 
disturbances in the chakras, meridians and energy fields.5-10 In theory, HT uses 
noninvasive hand techniques to balance human and environmental energy 
disturbances, remove biofield blockages, restore innate healing forces and 
reactivate the mind-body-spirit connection.6,7,9,10 
 
Bioenergy healing is controversial. Whereas the art of HT has long been 
established, only recently has science begun to explore the bioenergy healing 
realm; hence definitive proof of its clinical value is sparse. There is however, good 
scientific evidence to indicate that bioenergy fields exist.4,5,11 Yet neither the ability 
to manipulate these energies by thought or intention, nor the existence of chakras 
and meridians have been conclusively proven. This lack of knowledge makes it 
difficult for professionals to respond to the voluminous testimonials of success. 
Without evidence that either supports or refutes the benefit(s) of energy medicine, 
health fraud and quackery will prevail. The problem is serious. Unproven 
remedies may be harmful and waste money, and using ineffective practices may 
prevent people from getting necessary medical treatment. 
 
The clinical efficacy of HT within conventional medical science appears to be in 5 
main areas: reduction of anxiety/improvement in mood/well-being,12-20  relief of 
pain,15,16,19-24 hastening of wound healing,25-27 immune modulation28,29 and 
improvement of sleep.20,22,30,31 Much of the research demonstrating benefit has 
employed observational approaches (qualitative studies, case studies or patient 
satisfaction measures) rather than experimental design. However a few rigorous 
studies exist, such as the randomized trial20 that demonstrated burn patients 
receiving HT compared to sham treatment had reduced pain scores after 5 days 
of treatment.  
 
Whereas estimated incidence of insomnia in the general population is 10 to 
20%,39 sleep deprivation is present in nearly every critically ill burn patient 40    

 
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and ranges between 20 – 40% in children multiple years following injury.31,41-43 
The cause of pervasive degradation of sleep quantity and quality in acutely injured 
patients is multifactorial, including nocturnal treatment interruptions and 
medication side effects.33-35,41,43-50 Physiologic deterrents to sleep include the 
wound itself and the metabolic response to injury and infection.44-53 Psychological 
stress such as pain and anxiety disturb sleep.54-57 Sounds  associated with patient 
care, monitoring equipment, infusion pumps, phones, pagers, television and 
conversation as well as room light interfere with sleep and body rhythms normally 
entrained by daylight and darkness.44,46,47,49-74 More difficult to explain is the 
finding that sleep disruption continues post discharge, long after the wound has 
healed.31,41-43,75-79 The chronic nature of postburn and/or postsurgical dyssomnia is 
unsettling in view of its insidious effects on quality of life, wound healing and 
health. Experts in sleep medicine have also demonstrated significant 
psychological consequences of sustained sleep inadequacy and sleep 
fragmentation. Sleep disturbances predispose individuals, especially children, to 
heightened anxiety, attention-deficit hyperactivity disorder, impaired memory, 
reduced cognition and poor social integration.80-85   
 
Sleep deficiency is of concern because insufficient restorative sleep is an added 
stressor to the patient and may be a potential impediment to recovery.46,86 Achieving 
adequate sleep represents an unmet need during hospitalization. We speculate that 
re-establishing normal sleep patterns will help to accelerate patient recovery from the 
metabolic and psychological abnormalities commonly associated with surgery and 
ultimately improve well-being. The significance of this study is that it will establish the 
efficacy of HT as a therapeutic intervention for improving sleep in hospitalized children 
during the perioperative period as well as characterize electroencephalographic 
energetics associated with HT using a prospective, randomized blinded design.  
 
Because clinical and pharmacological modulation of postburn sleep disturbance 
has been largely ineffective,32-38,87,88 we explored the utility of HT as a potential 
sleep intervention. The investigation involved 10 children undergoing burn 
reconstructive care.31 Patients were studied an average of 7.2 + 2 years postburn. 
Subjects were randomized to HT versus no HT treatment using a 2 period 
crossover design. Data revealed that HT had a significant effect on both the 
quantity and quality of sleep. Total sleep time (TST), sleep efficiency, stage 2 
sleep (N2) and number of REM periods were significantly enhanced with HT. The 
percent of time asleep increased during the first 7 hours, which suggests that HT 
had an extended effect on the parameters being examined beyond that incurred 
during the HT procedure. Findings of remarkable HT benefit31 provide the 
impetus for this follow-up confirmation study.   
 

 
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Taken together, our extensive prior work characterizes significant dyssomnia following 
injury. Sleep disturbances are long term in nature with widespread health implications for 
children recovering from burns. Compared with a normal population, seriously burned 
patients (both acute and rehab/outpatients) demonstrate significant sleep disturbance 
manifested by decreased total sleep time, frequent arousals, impaired sleep efficiency, 
nightmares and deficient stages of 3+4 and REM sleep.  The pathophysiology underlying 
postburn sleep deprivation is clearly multifaceted and has not been fully elucidated. Our 
investigations have led to breakthrough preliminary findings demonstrating the possible 
clinical efficacy of HT as a sleep intervention.31  
 
1.2 Rationale and Risks/Benefit 
     1.2.1 Rationale: Our work is unique because no one has ever related                        
electroencephalography (EEG) recordings of energy to HT. Healing touch may 
prove  useful in the treatment of refractory sleep disorders common during 
recovery and could lead to widespread application worldwide in terms of its 
development as a safe, economical and non-invasive procedure that promotes 
sleep, physiological restoration and psychological well-being. Such findings 
would dovetail nicely with the Affordable Care Act as America transitions to 
value based care, requiring the adoption of therapies that emphasize lower 
costs and improved quality of life.  
 
1.2.2 Risks/Benefit: This study involves no more than minimal risk. There may not   
be direct benefit noted for study subjects; information from this study may 
influence the care of surgical populations in the future. This information is 
communicated to participants/consenting parents/legal guardians upon        
study introduction and is noted upon consent. The risks of this study are 
minimal; however, the potential for HT therapy to promote sleep and improve 
postoperative morbidity in elective surgery populations is novel and significant.  
 
2.0 Objectives: 
There is a fundamental gap in understanding how the energy-based, CAM approach of 
HT can be used to maximize health and improve recovery following disease or injury. 
Whereas the art of HT has long been established, there has been a recent explosion in 
its integration as a therapeutic intervention. However, proof of its mechanistic action and 
clinical value is lacking. Our long-term goal is to expand the capacity for improved 

 
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medical care and enhanced quality of life of children and young adults in alignment with 
the Affordable Care Act which emphasizes value and reduced health care spending. The 
objective of this study is to develop foundational scientific evidence that validates efficacy 
of a standardized HT intervention designed to promote sleep, a proven integral 
component of repair and recovery. These data are critical to advance the science and 
practice of HT, ultimately providing understanding of how this type of CAM can make a 
positive contribution to patient care. Our central hypothesis for this investigation is that 
HT generates improvement in a recipient’s sleep in association with 
electroencephalographic changes. We formulated this hypothesis on the basis of strong 
preliminary data demonstrating that HT has a positive impact on PSG outcomes.  We 
further postulate that HT and its associated increase in restorative sleep will benefit 
common sources of preoperative stress and/or postoperative anguish (e.g. anesthesia 
emergence, pain, anxiety, nausea). With recognition that well-designed clinical trials of 
HT are sparse; secondary objectives of this application are to produce cost to benefit 
information and to determine if patient satisfaction is enhanced by the addition of HT. 
 
2.1   The primary objective of this study is (Aim 1) to determine the safety and efficacy of 
healing touch intervention on improving measures of sleep.   
         With recognition that our original work demonstrating deficits in sleep and quality of 
life outcomes in hospitalized children, this prospective randomized trial will 
examine a new method for improving sleep. We postulate that HT will safely 
modulate changes that favor enhanced restorative sleep outcomes measured by 
PSG variables such as total sleep time (TST), sleep efficiency, sleep stages and 
time awake after sleep onset (WASO).  
 
2.2    A secondary objective of this study is to establish the value of HT on perioperative 
management of surgery-related outcomes (Aim 2).  
 
The intent of this aim is to evaluate the impact of HT on distress preceding surgery 
as measured by anxiety, pain, and laboratory indices of stress. This investigative 
aim will also assess the effectiveness of HT postoperatively in management of 
anesthesia emergence, sedation, anxiety, and pain reflected by clinical, 
psychometric and medication measures of well-being as well as track the incidence 
of postoperative nausea/vomiting. Upon completion of this study objective, it is 
expected that important information will be provided that determines whether HT 
intervention can mediate clinical improvement and comfort measures.   
 
2.3    An additional secondary objective is to examine measures of patient satisfaction 
and cost of care associated with HT (Aim 3). There is a need to ensure the value of 
healthcare services.  Therefore, in addition to safety/efficacy considerations, 
additional key determinants of quality-based surgical care include patient 
satisfaction and financial outcomes.  We will connect satisfaction and cost findings 
to clinical outcomes, with the goal of providing an objective interpretation of 
benefits and costs. These essential steps will justify (or contest) the value of HT 
services within the framework of perioperative clinical practices. 
 
2.4   The rationale of selection of outcome measures (sleep, surgery- related outcomes, 
patient satisfaction and cost of care) is that Healing Touch is expected to provide 
an inexpensive, non-invasive method that will prosper as a safe and efficacious 
adjunctive preoperative treatment.  
 
3.0 
Subject Selection:  

 
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3.1 Inclusion Criteria  
3.1.1 
5 years to 25 years of age 
3.1.2 
Scheduled for an elective operative procedure  
3.1.3 
Written informed consent and HIPAA release signed by parent or legal 
guardian; assent as appropriate  
3.2 
Exclusion Criteria 
3.2.1 
History of anoxic or suspected brain injury  
3.2.2 
History of head injury within the last year 
3.2.3 
Face/head phenomena that prevents proper placement of PSG leads 
3.2.4 
No informed consent or HIPAA release 
3.3 
Inclusion of Gender and Minorities 
3.3.1 
Entry into this study is open to patients of both genders and all ethnic 
backgrounds.     
3.4 
Subject Recruitment, Enrollment and Consent Process 
3.4.1 
Study specific recruitment cards, a 1 page flyer and also a patient 
education brochure describing healing touch will be used for marketing.  
Patients requiring surgery will be invited to participate by receiving 
recruitment information in person and/or via a mailing of related study 
materials to their home. Before surgery, a staff member from Patient 
Access may encourage patient or caregiver to look for study information 
when they receive their study packet mailing (per script).  This will occur 
during the normal preoperative phone call.  In addition, a study co-
investigator may contact patients or caregivers) per script who are 
identified as potential candidates. Once study information has been 
reviewed by the patient/family, and the patient/family is agreeable to 
participate in the study, a study co-investigator will work with scheduling 
personnel to plan research admission the evening before elective surgery. 
  
3.4.2 
Informed consent will be obtained from the participants and/or their legal 
guardians by trained staff authorized to consent for this study.  
             3.4.2.1 The conversation is expected to include a thorough discussion of  
            what is expected to happen during the study, risks and benefits of 
            the planned therapy, and any possible alternatives.   
             3.4.2.2 The family will be given a copy of the signed consent form.            
3.4.2.3 For participants who are less than 18 years of age, some of these 
            participants are able to give assent and others are too young.  If it 
            is determined that a participant is able to give assent (generally     
            children 11 years or older), the consenting staff will attempt to       
            explain the study at both the participant’s and the legal guardian’s 
            comprehension level.  
 
4.0 
Study Design/Procedures: 
 
4.1 
General Design 
4.1.1 Elective surgery patients will be prospectively assigned to treatment group 
using single blinded stratified randomization. A cross-over trial was considered 
but because our prior work suggests that HT has an extended carryover and thus 
an effect on outcome,31 we felt this would not be an appropriate approach. If HT 
is performed before the non-HT period, there could be residual HT effects 
manifested during the non-intervention period.  

 
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A single blinded stratified random block randomization scheme89 will be 
generated by the study statistician (LJ) who will conceal group assignment from 
the blinded polysomnography technician and blinded board certified sleep 
physician as well as the blinded biostatistician (JK) who will analyze the data.  
Intervention assignment will also not be conveyed to the study 
subject/caregiver(s).  The stratification is based on possible influential variables 
grouping for age (5 to 11, >11 years) and also acuity (levels 1 and 2) whereby 
level 1 is defined as same day surgery and observation (e.g. patients are 
technically never admitted as inpatient). Level 2 represents patients admitted for 
≥ 24 hours and therefore assigned an inpatient encounter of surgical procedure. 
Also carefully considered was the study design; the blinding and suitable control 
groups.90-96 Following screening per inclusion/exclusion criteria and upon verbal 
agreement to participate, 200 subjects will be randomly assigned to receive one 
of four interventions: healing touch, sham, control no presence, or control 
presence.  The subjects will not be informed of group assignment. No study 
procedures will be performed until written informed consent (and assent as 
appropriate) is obtained. The consenting process will take place in a private area. 
The investigator will ask open-ended questions of the consenting 
parent(s)/assenting subjects regarding study methods to determine level of 
comprehension. The consent process including consenting parents/assenting 
subjects verbalization of understanding of the study will be documented in the 
medical record. 
This is a prospective, randomized trial with 4 treatment groups:  
Healing touch (active intervention, focused intention) will be performed by 
certified HT practitioner. Our pilot work revealed a HT effectiveness 
covariate to be therapist stress e.g. divorce (unpublished findings) therefore 
prior to each HT procedure, the practitioner will complete a stress survey. No 
interpretation of survey results will be made relative to the assigned therapist 
performing HT.  The HT practitioner will be entered into the model as a fixed 
effect.  Rather, the survey score will be examined during data analysis to 
determine if stress is an effector of HT effectiveness.  HT will begin per 
standardized HT methodology97 at approximately 2200 on the night prior to 
surgery.  The HT practitioner will have the appearance of listening to music 
using a headset that is not connected to a media player.  Before onset of HT, 
the subject will be encouraged to relax while lying down. The HT practitioner 
will perform self-centering exercises at the patient’s bedside in order to center 
or quiet the practitioner’s own mind, creating an atmosphere devoid of 
anxiety so the practitioner can focus compassionately and with full presence. 
Once centered, the practitioner uses three techniques in conjunction with 
approximately 60 minutes of soft background music during the study 
intervention: 1) Magnetic clearing (approximately 10 minutes) which cleanses 
the subject’s energy field to assist in releasing emotional debris and feelings 
of fear, anger, worry and tension. The practitioner does the energy clearing 
by making 15-30 full length smooth, gentle, continuous passes (usually 
downward and outward direction) with both hands one to six inches from the 
patient’s body. 2) Mind Clearing (approximately 10 minutes) used for 
relaxation and to focus or quiet the patient’s mind. It consists of the 
practitioner’s hands placed lightly on or above specific sites around the head, 
neck, forehead and face with the intention of balancing the right and left sides 
of the brain. 3) Full Body (Chakra) Connection (approximately 20 minutes) 
connects, opens and balances the energy centers to enhance the flow of 
energy in the body. The hands are placed on the ankle and knee, then knee 

 
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and hip, then the same sequence is repeated on the other leg, then both hips, 
then at the root chakra (between the legs, off the body about 12 inches away) 
and lower abdomen, then at the lower abdomen and solar plexus, then the 
solar plexus and spleen area, then the heart (mid chest) and solar plexus, 
then the heart and thymus, then at the wrist and elbow, then the elbow and 
shoulder, then the other arm, then both shoulders, then the neck and brow, 
then the brow and top of the head, and then the top of the head and about 12 
inches above the head. The next morning, the HT practitioner will extend 
healing and compassionate thoughts to the subject from a remote location as 
the subject prepares for surgery.  
Sham (placebo treatment) session will also be conducted at comparable time 
and duration as the active intervention and with analogous environmental 
conditions including presence of identical soft background music. The sham 
HT aide will be engaged with the subject yet has no experience with or 
knowledge about healing touch. The standardized clinical encounter will 
appear to be similar to the active treatment and the well-trained sham aide 
will interact with the patient in accordance with a standardized, 
choreographed mock routine involving body motions that mimic HT. There 
will be no positive intent or patient contact; instead the sham aide will 
silently count backward from 100 to 1, continuously repeating this 
sequence during the entire sham procedure while listening to music from 
portable compact media player with ear phone headset with the purpose of 
distracting the sham aide’s mind so that compassionate thoughts are 
circumvented.   
Control presence whereby a research aide who is not familiar with HT will 
be present in the patient’s room from approximately 2200 – 2300. The 
research aide will not engage/interact with the research subject.  A staff 
nurse will inform the patient that the aide is not permitted to converse with 
the subject. The aide will quietly sit in a corner of the patient’s room, 
listening to media player using earphones similar to that described during 
active intervention. Identical soft background music to that used during active 
intervention will be audible to the patient during the approximate 1-hr study 
period. 
Control no presence involves no study aide presence in the room. A course 
of soft background music identical to intervention groups will begin at 
approximately 2200. 
 
The sleep technician will document that an experimental procedure was 
performed and note any unexpected occurrences (interruptions, HT side 
effects) at the end of the 1 hour intervention/control period using the 
demos/safety CRF.  
   
4.1.2  Study duration is from approximately 9 pm (when the electrodes are attached for the 
sleep test) the evening prior to surgery until 8 hours after surgery the following day 
(unless patient is discharged earlier than 8 hours postop).  
 
4.1.3 A description of the sequence and duration of the study procedures are summarized 
in the below diagram: 
 
 
 
                                                               
 
 
The Night before Surgery 
 
Vital Signs 
 
Sleep Test with Electrodes  
 
Study Intervention for approximately an hour   
                  † Intervention interruption and intolerance checks   

 
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4.2 
Study Procedures  
PSG will be performed the night before surgery. PSG (Sandman ELITE Sleep 
System, Natus Medical Inc, Buffalo NY) will include simultaneous nocturnal 
recording of EEG, electromyelogram (EMG), electrooloculogram (EOG), 
respiration, heart rate, oxygen saturation, video and audio recordings and body 
movement in 30-second epochs. Subjects will be connected to PSG at 
approximately 2100 with recordings from approximately 2200 until 0600 the 
following morning (unless patient has an early surgery time). Soft music will play 
for approximately 60 minutes in all groups after the sleep machine is turned on. 
In an effort to assure concealment of group allocation during scoring of the 
sleep data, scoring will be delayed for approximately one month following study 
intervention.  In addition, the video will be turned off during the first hour of 
   In the Morning (Preop)  
 
Vital Signs  
 
Anxiety Score  
Patient Unit 
 
Vital Signs 
 
Nausea/Vomiting 
 
Pain Score  
 
Satisfaction Survey 
Post Anesthesia Care Unit 
 
Anesthesia recovery  
 
Sedation Score 
 
Vital Signs  
 
Nausea/Vomiting  
 
Pain Score 
                            Surgery 
 
Blood draw for study labs 
 
Vital Signs 
 
Vomiting 

 
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scoring performed by the registered sleep technologist.  The American 
Academy of Sleep Medicine’s (AASM) newly released guidelines, The AASM 
Manual for the Scoring of Sleep and Associated Events: Rules, Terminology and 
Technical Specifications98 will be used for scoring and interpretation of sleep 
stages. PSG provides comprehensive summary reports of sleep stages and also 
generates sleep latency, TST, WASO, arousals and sleep efficiency measures. 
Narong Simakajornboon MD, Director of the CCHMC’s Hospital Sleep Disorders 
Center and board-certified sleep specialist, blinded to experimental conditions, 
will perform the specialized data interpretation. A copy of the sleep test report will 
be provided to study participants. 
 
Patients will have vital signs (temperature, respiration, heart rate, blood 
pressure) assessed prior to the sleep study and repeated preoperatively (the 
morning of surgery).  Vital signs and vomiting will be assessed in the operating 
room.  Vital signs, and pain score (using an observational scale99 [OPAS] 
and/or numeric rating [1-10 scale] as appropriate) will be assessed post-
operatively both upon arrival to the post-anesthesia care unit (PACU) and 
before PACU discharge.  Vital signs, and pain score will also be recorded upon 
arrival to post-recovery patient room and at discharge.  Nausea and vomiting 
will be assessed in the PACU and in the post-recovery patient room. Minutes 
in the OR, PACU and patient room (time from arrival until discharge) will be 
recorded.   
 
Laboratory parameters (C-reactive protein, glucose, cortisol and D25) will be 
obtained (from approximately 5 mL of blood) in the operating room.  Since there 
is a strong argument that HT reduces stress and anxiety, the results of this 
study could provide data demonstrating improved hormonal balance following 
HT intervention. There also exist reports linking sleep with metabolism of 
glucose and vitamin D. 
 
An anxiety test (Yale Preoperative Anxiety Scale) will be obtained 
preoperatively (in patient unit prior to preoperative meds and repeated in the 
preoperative surgery area).100 Anesthesia emergence score, sedation score 
and nausea and vomiting will be assessed in the PACU.101-103 Incidence of 
nausea and vomiting in the post recovery patient room (on the floor) will also 
be recorded.   
 
A patient satisfaction survey will be administered post recovery that includes 
questions specific to the HT procedure, sleep and also includes four questions 
identical to that contained in Press Ganey Pediatric Inpatient survey (questions 
B5, D4, K3 and I9; http://www.pressganey.com/) to assess contentment with 
overall inpatient care.  
 
Implicit in the definition of economic consequences of healing touch, we will also 
collect select utilization and cost outcome measures including total charges from 
admission to study discharge as well as charges specific to the Post Anesthesia 
Recovery Room.  Labor cost of HT, length of stay in recovery room (number of 
minutes), length of hospital stay (number of hours) and medications administered 
for sleep, anxiety, pain, itch, nausea, vomiting and anesthetics during the defined 
study period all have high cost implications and thus will be examined as well.   
   
5.0 
Subject Safety  
 

 
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5.1  
Patients will be closely monitored by clinical investigators via the Sleep 7 Data 
Safety Monitoring Plan as well as comply with the SHC-Cincinnati Safety 
Monitoring Process for Clinical Research CR 6.10 standard operating procedure 
whereby Adverse Events, Serious Adverse Events, Unexpected Adverse Events 
and Expected Adverse Events are defined therein. 
5.2 
Subject Risk 
5.2.1 No extraordinary risks are expected with this investigation. The 
risks explained below are reasonable given the expected benefits 
described herein. 
5.2.2 Healing Touch Procedure - There are no known safety concerns. 
Rare side effects include emotional outbursts, muscle spasm, 
restlessness, dizziness and headache. Empirical explanation for such 
responses: recipient release of stagnant blocked energy resulting in 
outburst or physical jerks; hours later the subject may express a 
cathartic outcome (unpublished data, Lois Cone 3-5-15).  
5.2.3 Polysomnography - Risks associated with PSG include possible 
difficulty sleeping and local skin irritation from electrode placements. 
5.2.4 Venipuncture - The risks from blood draw of study labs include: 
commonly, the possibility of discomfort and/or bruise at the site of 
needle stick and, less commonly, the formation of a small blood clot or 
swelling of the vein and surrounding tissue, and bleeding from the 
needle stick site.  
5.3       Safety Assessment 
5.3.1 Healing Touch Procedure - We seek to document the safety of 
HT bioenergy therapy as a modality contributing significant benefit with 
minimal to no risk to the patient.  As such, each subject’s tolerance to 
the healing touch procedure will be monitored. Safety assessment 
includes observing the patient for emotional outburst(s), muscle 
spasms, restlessness, dizziness, or headaches during the bioenergy, 
sham and control/presence nights.  The safeguards and/or precautions 
that will be taken to avoid risks and discomforts are that study staff will 
monitor tolerance during the HT intervention and document any noted 
symptoms or complaints before, during, and immediately after the 
intervention.  The HT session will be stopped as needed.  Results from 
the satisfaction survey will also be examined for tolerance. 
5.3.2 Polysomnography - The known minimal risk of participation in this 
study (ie - risk reaction to PSG leads) and other postulated tolerance 
risks will be monitored. The safeguards and/or precautions that will be 
taken to avoid risks and discomforts from the sleep study include that 
study staff will monitor tolerance during the sleep study; testing will be 
stopped as needed; an experienced, licensed sleep study specialist will 
attach the electrodes to the face/head areas. 
5.3.3  Venipuncture - Experienced medical personnel will be 
responsible for obtaining the blood sample, prior to surgery. 
5.3.4 To the extent that Shriners Hospitals for Children® (SHC) provides medical 
services at its facility, care for these rare (and speculated) side effects will be at 
no cost to the family. Although not anticipated, any intolerance noted to the HT, 
PSG and/or venipuncture procedure(s) will be documented; and depending on 
severity, may precipitate study withdrawal. 
5.3.5 This study involves no more than minimal risk. There is no direct benefit 
noted for study subjects; however, information from this study may influence the 
care of surgical populations in the future. This information is communicated to 

 
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participants/consenting parents/legal guardians upon study introduction and is 
noted upon consent. 
 
5.4       Serious Adverse Event (AE) Reporting 
5.4.1 In accordance with our study specific safety monitoring plan as well as the 
SHC-Cincinnati Safety Monitoring Process for Clinical Research CR 6.10 SOP, 
patients will be closely scrutinized by clinical investigators for AEs. Even though 
there are no known serious side effects reported with HT therapy, subjects will be 
screened for dizziness, headache, and restlessness prior to the 
intervention/control session. In addition, subjects will be evaluated during the HT, 
sham and control/presence groups for emotional outburst, muscle spasm and 
restlessness during the study intervention time as well as any changes in the 
status of dizziness or headache following the study intervention period.  
Continued monitoring will occur until end of study (up to 8 hours postoperatively) 
to assess for persistent treatment effect. 
5.4.2   Any Serious and Unexpected AE and Grade 3 or above, with a reported 
causality of “possible,” “probably,” or “likely” must be reported to the Study PI and 
Medical Staff Co-Investigator in an expedited method. 
            5.4.3  All reported AEs will be classified using the Common Terminology Criteria 
            for Adverse Events (CTCAE), version 4. 
            5.4.4  Each AE is associated with a grade. Grade refers to the severity of the AE. 
            The CTCAE v4.0 displays Grades 1 through 5 with unique clinical descriptions of 
            severity based on this general guideline: Grade 1 = mild, Grade 2 = moderate,     
            Grade 3 = Severe, Grade 4 = Life-threatening or disabling, Grade 5 = Death. 
                        5.4.5 Grade 4 or 5 events must be reported to Study PI within 24 hours with        
                        written documentation of the event filed within 7 days of the event. 
                        5.4.6  CCHMC’s IRB must be notified of any Serious and Unexpected adverse    
                        event within 7 days. 
            5.4.7  Study PI will ensure that SHC home office and all applicable regulatory      
            organizations are notified per regulatory guidelines. 
                        5.4.8  Study PI will notify all participating investigators of any reported SAE          
                        associated with the trial. 
 5.5      Annual Reporting 
The principal investigator will report all other safety events to the CCHMC IRB          
consistent with current institutional policy/SOP. Serious AEs that do not meet the 
criteria for expedited reporting as well as non- serious adverse events will be 
reported at the time of submission of annual IRB Progress Reports. Likewise, minor 
deviations will be reported in annual reporting to the CCHMC IRB. All other 
reportable events will be conveyed to the CCHMC IRB office, in summation form, at 
the completion of the study. 
 
6.0 Data Handling and Record Keeping 
6.1    The specific variables involved in data collection are detailed under study  
         procedures and reflected in CRFs as well as within the listing of Sleep 7 source     
         documents.  
6.2 Data collection for this study will primarily be through an online data management 
system housed on SHC servers. Members of the SHC research team will enter 
data into SHC system with unique user IDs and passwords. All secure web-based 
information transmission is encrypted and complies with HIPAA security guidelines 
and 21 CFR 11.   
6.3 Confidentiality and Security             

 
                                                                      20                                   Sleep 7 IRB – Version 2.1 
         
6.3.1 Information about study subjects will be kept confidential and managed        
according to the requirements of HIPAA.  
6.3.2 Access to data collected for this study is limited to study investigators.   
6.3.3 In the event that a subject revokes authorization to collect or use PHI, the 
investigator, by regulation, retains the ability to use all information collected 
prior to the revocation of subject authorization. For subjects that have 
revoked authorization to collect or use Private Health Information (PHI), 
attempts should be made to obtain permission to collect at least vital 
statistics (i.e. that the subject is alive) at the end of their scheduled study 
period. 
6.4 
Source Documentation 
6.4.1 Source data are contained in source documents.  Examples of original 
documents and data records specific to this study include: hospital 
records and PSG reports. 
6.4.2 When observations are entered directly into a computerized system, the 
electronic medical record (EMR) or other electronic record (ex. PSG) is 
the source document.  Examples of EMR source documentation specific 
to this study include: patient demographics, medication records, time in 
PACU, vital signs, pain scores, and laboratory parameters. 
6.4.3 Select data will be recorded directly on case report forms. These forms 
will be used as “source documentation” and include the intervention 
safety assessment, HT practitioner stress survey, the preoperative data 
collection form and HT satisfaction survey. 
6.4.3.1  All data requested on the CRF must be recorded.   
6.4.3.2  All missing data must be explained.   
6.4.3.3  If a space on the CRF is left blank because the procedure was 
not done or the question was not asked, write “N/D”.  
6.4.3.4  If the item is not applicable to the individual case, write “N/A”.  All 
entries should be printed legibly in black or blue ink.   
6.4.3.5  If any entry error has been made, to correct such an error, draw a 
single straight line through the incorrect entry and enter the correct data 
above it.  All such changes must be initialed and dated.  DO NOT ERASE 
OR WHITE OUT ERRORS.  For clarification of illegible or uncertain 
entries, print the clarification above the item, then initial and date it. 
6.5 
Record Retention 
6.5.1 Clinical research records will be retained per SHC standard operating 
procedure on Clinical Research Records Retention (MR-002). 
6.6 
Laboratory Specimens 
Lab tests (CRP, glucose, cortisol and vitamin D25) will be processed and 
managed by SHC Laboratory Medicine.   
 
7.0     Quality Control and Quality Assurance   
            7.1     Internal auditing will be performed quarterly to ensure that the data are accurate,   
            consistent, complete and reliable and in accordance with ICH GCP guidelines and 21     
            CFR 11.   
            7.2    The study PI will assess the audit worksheet, classify type of discrepancy and  
            develop appropriate action plan. 
 
8.0 
Statistical Considerations 
8.1     All data will be managed and analyzed using SAS® Version 9.3 (SAS Institute, 
Cary, NC) unless otherwise stated for specialized analysis. Demographic and 
summary data will be compiled and entered into the SAS research database by a 

 
                                                                      21                                   Sleep 7 IRB – Version 2.1 
         
trained data manager. The database has been in use for 14 years; it will be adapted 
for data entry specific to the new project. The database is stored on SHC’s dedicated 
network drive. The network is security- and backup- protected by SHC information 
systems on a daily basis. In addition, the individual study files are password 
protected. The programs are run by the statistician and verified by a research 
investigator. Prior to embarking on any analysis, variables will be checked for 
outlying values.  Distributional properties of the continuous variables will be 
examined and any transformations necessary for analysis considered. Bivariate 
comparisons will follow, to look at differences in baseline variables between HT and 
control groups (ex. age, gender and race, also length of time and type of surgical 
procedure e.g. burn versus other reconstructive procedure). These latter variables 
are potential covariates for secondary analysis. Analysis of variance (ANOVA) or 
Kruskal-Wallis test and Chi-square analysis will be used for these comparisons. 
Similarly, the association between outcome variables and baseline variables will be 
examined; correlation and ANOVA or Kruskal-Wallis will be used as appropriate. 
 
8.2 The first approach for a clinical trial is usually intent-to-treat analysis. In the case 
of a missing end-point, where possible, the subject will be assigned to the “worst” 
possible value. However, this is not feasible for our sleep outcomes.  A second 
approach would be to include those subjects with outcome data, complete case 
analysis. Last observation carried forward is also commonly used, but this method 
can be biased, but will be examined. Multiple imputation (MI) methods have been 
proposed92,104,105  and may be superior, but are not without problems, mainly bias with 
respect to missing data. In case the missing mechanism is not missing completely at 
random,106 we will conduct a missing data analysis to address the question of bias. If 
the missing mechanism depends on group assignment (HT, sham or one of the 
control groups) or other demographic variables, we will estimate the bias using 
logistic regression. Bias adjusted analyses would then be conducted using the 
inverse of the estimated probability of being missing as the weighting factor. We will 
be able to do this by applying a weighted generalized estimating equations (GEE) 
method.107 Thus we will use MI or weighted GEE method as appropriate, as well as 
complete case analysis. In general, it will be appropriate to use generalized linear 
random effects mixed model for analysis. This will allow for repeated nature of the 
outcome variables, and specification of the appropriate link function, dependent upon 
the type of outcome variable. SAS PROC GENMOD may be used for these analyses 
and using PROC GLIMMIX would also allow invocation of the GEE method if 
required. As mentioned above, bivariate relationships between outcome variables 
and independent variables will be examined; this will also be in preparation for 
consideration of any secondary analyses incorporating covariates and confounders. 
Variables considered as potential covariates in an initial model will either be those 
considered clinically significant irrespective of the statistical association and those 
associated with the outcome and independent variable of interest at p<0.15. Inclusion 
in final models will depend upon statistical significance (p<0.05) or effect of removal 
of the variable on the beta coefficient (>10% change) on the independent variable of 
interest. Age and gender will be considered clinically meaningful and will be retained 
in the model independent of statistical significance.108 
 
8.3 Primary Study Endpoints  
8.3.1 Statistical Analysis (Primary Objective) 
The primary treatment endpoint for Aim 1 will be generated from PSG.  Group 
comparisons will be made for total sleep time, sleep efficiency, REM, WASO and 
spectral analysis of C3/C4 delta waves, using a generalized linear random effects 
model. Secondary analyses will involve adding appropriate covariates to the 

 
                                                                      22                                   Sleep 7 IRB – Version 2.1 
         
model. Age and gender will be retained. Potential covariates include prior 
experience with HT, medication usage, frequency of random disturbances (such 
as parents or other caregivers entering the room, cell phones) and number of 
prior surgical procedures. The same approach will be used to examine 
hormones, anesthesia emergence, anxiety, and pain scales (Aim 2), the 
advantage is that the appropriate link function may be applied and we can 
account for the repeated nature of the design. 
 
Power Analysis 
 
 
Variable 
Median 
(25th, 75th  
percentile) 
Healing Touch night 
N=15 
Non-Healing Touch 
night 
N=15 
p-value 
TST 
minutes 
 
400 (302, 442) 
 
366 (287, 396) 
 
.09 
Sleep 
efficiency 
% 
 
80 (61, 90) 
 
78 (56, 82) 
 
.07 
WASO 
minutes 
 
72 (47, 160) 
 
85 (82, 181) 
 
.60 
REM 
minutes 
 
86 (62, 93) 
 
63 (40, 97) 
 
.30 
 
The measures targeted are TST, sleep efficiency, REM sleep and WASO. This 
Table shows data from a pilot cross-over study (median and 25th and 75th 
percentile) for the sleep variables of interest for 15 study subjects. In order to see 
the HT group with longer TST than the other groups, we will need a sample size 
of 50 per group for 80% power to detect a difference of 35 minutes, standard 
deviation of 70, assuming a 2-sided test and type I error rate of 0.016 to account 
for multiple testing. Similarly for sleep efficiency, we hypothesize a difference of 
2% whereas in a previous study we observed a difference of 10%.31 Using the 
sample size of 50 per group we would be able to detect a difference of 7% with a 
standard deviation of 15, 2-sided test and type I error rate of 0.016, to account 
for comparing HT to the 3 control groups. Because the percentages depend 
upon another time dependent variable, the power is based on REM minutes. 
Using REM minutes, 50 subjects per group would enable us to detect a 15 
minutes difference in REM sleep, assuming a standard deviation of 30, power of 
80% and a 2-sided test. For WASO, with an assumed standard deviation of 50, a 
type 1 error rate of 0.016, a power of 80% and a 2-sided test, a difference of 25 
minutes will require 50 subjects in each group, producing a total sample size of 
200 subjects. 
 
8.3.2    Statistical Analysis (Aim 2) 
Analysis will follow the general approach and then the same specific approach as 
described for Aim 1, looking at differences in outcomes among groups utilizing 
generalized linear models. Using this methodology we will be able to examine the 
differences over time baseline to post recovery, examining the change between time 
points adjusting for baseline and the interaction between time and group. The 
secondary approach would examine the difference among groups adding covariates, 

 
                                                                      23                                   Sleep 7 IRB – Version 2.1 
         
accounting for age, gender and other potential covariates such as number of prior 
surgeries, length of time in surgery and type of surgery (burn related or other). 
 
Using our validation information for the OPAS pain assessment scale107 with 48 
subjects per group, we have a power of > 80% to detect  a reduction in pain scale of 
0.4 given the standard deviation of 0.52, using a type I error rate of 0.016 (to account 
for the multiple testing) and 2-sided test. Given the 0.3 difference in pain reduction 
between preverbal and nonverbal in the validation study, the expected difference 
appears reasonable.  Similarly using prior work performed at our hospital103 which 
examined the rate of postoperative nausea and vomiting after reconstructive burn 
surgery, with 46 subjects per group we would have 80% power to detect a difference 
of 69% in the control versus 40% in the HT group with a 2-sided test and type I error 
rate of 0.05. However after accounting for the multiple testing, using type I error rate 
of 0.016, the power is reduced to 70% with the 50 subjects per group estimated for 
the proposed study. Turner et al20 reported on pain after dressing change in older 
adolescents and adults.  In their randomized trial of therapeutic touch; a 23% 
decrease in anxiety was detected in the intervention group. If we assume that we will 
see this level of decreased anxiety in the HT group compared to the control and also 
assume an effect size of 0.7 and a type I error of 0.16, the 50 subjects per group 
(estimated for Aim 1) would yield 85% power for our analysis of anxiety. 
 
8.3.3 Statistical Analysis (Aim 3) 
The data analytic plan will follow that established for Aims 1 and 2 using a general 
linear model and use of the appropriate link function dependent upon outcome.  
Satisfaction variables are notoriously skewed in distribution and so may need to be 
dichotomized for analysis. Data analysis will be performed in a blinded fashion with 
regards to the subject and any group assignment.  The analysis of cost will include 
examination of cost to charge ratio (CCR).  Because cost fluctuates over time, the 
annual cost to charge ratio (obtained from Shriners Headquarters) will be used to 
calculate and apply CCR to charges pertinent to this study in order to determine if 
the expense of a 1 hour HT session translates to a change in dollars expended in 
PACU care, total length of hospital stay and morbidity treatment costs (ex. 
anxiety/pain/itch/anti-nausea medication expense). Cost-benefit analysis comparing 
those with HT versus no HT and by group will be conducted.  An expert in health 
cost/economics will be consulted where necessary for the latter analysis. 
 
Unfortunately we have no published data with respect to satisfaction or cost analysis. 
We will be able to detect an effect size of at least 0.66 with a sample size of 50 per 
group and accounting for multiple testing, with a 2-sided test, a type 1 error rate of 
0.016 and power is 80%. A power of 80% could be maintained with correlations as 
low as r=0.20.  
 
9.0 
Study Finance 
9.1 Funding Source 
This study is financed through a grant from the Shriners Hospitals for Children, North 
America. 
 
9.2 Participant Stipends or Payments  
A gas card valued at $20  will be provided to study participants (or families) as 
compensation for time or travel. 
 
10.0 References 

 
                                                                      24                                   Sleep 7 IRB – Version 2.1 
         
1. Barnes PM, Powell-Grinner E, McFann K, Nahin RL.  Complementary and Alternative 
Medicine Use Among Adults: United States, 2002.  Hyattsville, MD: U.S. Department of 
Health and Human Services, 2004. 
2. NIH.  National Center for Complementary and Integrative Health.  Available 
at:http://nccih.nih.gov.   Accessed April 1, 2015. 
3. NIH.  Considerations for NCCAM clinical trial grant applications.  
http://nccam.nih.gov/research/policies/clinical-considerations.htm. Accessed May 1, 2013. 
4. Rein G. Bioinformation within the biofield: Beyond bioelectromagnetics. J Alternative 
Complementary Medicine. 2004;10:59-68. 
5. Oschman JL.  Energy Medicine.  The Scientific Basis.  2000. Churchill Livingstone, St. 
Louis MO, pp. 85-109. 
6. Krieger D.  Therapeutic Touch Inner Workbook: Ventures in Transpersonal Healing.  
Santa Fe: Bear & Company, 1997. 
7. Krieger D.  Accepting Your Power to Heal:  The Personal Practice of Therapeutic Touch.  
Bear & Co: Santa Fe NM, 1993. 
8. Mentgen J.  Healing Touch:  A Resource for Healthcare Professionals.  Chapters 7-11, 
Delmar Publishers, Albany NY 1996. 
9. Wardell DW, Weymouth KF.  Review of studies of healing touch.  J Nurs Scholar  
2004;36:147-154. 
10. Mentgen J.  Healing touch.  Nurs Clin North Am 36:143-157. 
11. Rubik B. The biofield hypothesis: Its biophysical basis and role in medicine. J Alternative 
Complementary Medicine 2002;8:703-717. 
12. Heidt P.  Effect of therapeutic touch on anxiety levels of hospitalized patients.  Nurs 
Research 1981;30:32-37. 
13. Quinn JF. Therapeutic touch as energy exchange: testing the theory.  Adv Nurs Sci 
1984;6:42-49. 
14. Gagne D, Toye RC.  The effects of therapeutic touch and relaxation therapy in reducing 
anxiety.  Arch Psychiatr Nurs 1994;8:184-189. 
15. Post-White J, Kinney H, Savik K et al. Therapeutic massage and healing touch improve 
symptoms in cancer. Integrative Cancer Therapies 2003;2:322-344. 
16. Wilkinson D, Knox P, Chatman J et al.  The clinical effectiveness of healing touch. J 
Altern Complement Med 2002;8:33-47. 
17. MacIntyre B, Hamilton J, Fricke T et al.  The efficacy of healing touch in coronary artery 
bypass surgery recovery: A randomized clinical trial.  Alternative Therapies in Health and 
Medicine. 2008;14:24-32. 
18. Seskevich JE, Crater SW, Lane JD, Krucoff MW. Beneficial effects of noetic therapies on 
mood before percutaneous intervention for unstable coronary syndromes.  Nursing 
Research 2004;53:116-121. 
19. Wardell DW, Rintala DH, Duan Z, Tan G. A pilot study of healing touch and progressive 
relaxation for chronic neuropathic pain in persons with spinal cord injury. J Holistic 
Nursing 2006;24:231-240.  
20. Turner JG, Clark AJ, Gauthier DK, Williams M.  The effect of therapeutic touch on pain 
and anxiety in burn patients. J Adv Nursing1998; 28:10-20. 
21. Meehan TC. Therapeutic touch-postoperative pain: A Rogerian research study.  Nurs 
Science 1993;6:69-79. 
22. Marta IER, Baldan SS, Berton AF, Pavam M, Julia M, daSilva P.  The effectiveness of 
therapeutic touch on pain, depression and sleep in patients with chronic pain: clinical trial. 
 Rev Esc Enferm 2010;44:1094-1100. 
23. Peck SD. The effectiveness of therapeutic touch for decreasing pain in elders with 
degenerative arthritis.  J Holistic Nurs 1997;15:176-198. 
24. Gordon A, Merenstein JH, D’Amico F, Hudgens D. The effects of therapeutic touch on 
patients with osteoarthritis of the knee.  J Fam Pract 1998;47:271-277. 

 
                                                                      25                                   Sleep 7 IRB – Version 2.1 
         
25. Wirth DP, Richardson JT, Eidelman WS, O’Malley AC.  Full thickness dermal wounds 
treated with Therapeutic Touch: a replication and extension. Complementary Therapies in 
Medicine.  1993;1:127-132. 
26. Wirth DP. The effect of non-contact Therapeutic Touch on the healing rate of full 
thickness dermal wounds.  Subtle Energies 1990;1:1-20. 
27. Wetzel WS. Healing touch as a nursing intervention: wound infection following cesarean 
birth – an anecdotal case study. J Holist Nurs 1993;11:277-285. 
28. Wilkinson D, Knox P, Chatman J, Johnson T, Barbour N, Myles Y, Reel A. The clinical 
effectiveness of healing touch.  J Alternative Complementary Med 2002;8:146-151. 
29. Chen KW. Inhibitory effects of bio-energy therapies on cancer growth. World Science 
Technology/Modernization of Traditiona Chinese Med Materia Medica 2008;10:144-152. 
30. Engebretson J, Wardell DW. Energy-based modalities.  Nursing Clinics of North America 
2007;42:243-259. 
31. Cone LC, Gottschlich MM, Saylors S, Kagan RJ. The effect of healing touch on sleep 
patterns of pediatric burn patients.  J Sleep Disorders: Treatment and Care. 2014;3:1-6. 
32. Gottschlich MM, Khoury J, Warden GD, Kagan RJ.  An evaluation of the neuroendocrine 
response to sleep in pediatric burn patients. JPEN 2009;33:317-326. 
33. Armour A, Gottschlich MM, Kagan RJ, et al.  A randomized, controlled prospective trial of 
zolpidem and haldol for use as sleeping agents in pediatric burn patients. J Burn Care 
Res 2008;29:82-88. 
34. Jenkins M, Gottschlich MM, Khoury J et al.  Effects of pharmacologic intervention on 
sleep architecture in thermally injured patients.  Proc Am Burn Assn 1995;27:114. 
35. Healy DP, Gottschlich MM, Kagan RJ.  Pharmacokinetics of zolpidem in pediatric burn 
patients, J Burn Care Res 2011;32:5.143. 
36. Jenkins ME, Gottschlich M, Kopcha R et al.  An evaluation of therapeutic intervention on 
sleep architecture in the thermally injured patient.  J Burn Care Rehabil 2002;23:S86. 
37. Gottschlich MM, Mayes T, McCall J, Simakajornboon N, Kagan RJ. The effect of 
ketamine on sleep architecture.  J Burn Care Res 2011;32:535-540. 
38. Stockman C, Gottschlich MM, Healy D, Khoury JC, Mayes T, Sherwin CMT, Spigarelli 
MG, Kagan RJ. Relationship between Zolpidem Concentrations and Sleep Parameters in 
Pediatric Burn Patients. J Burn Care Res 2015;36:137-144. 
39. Leger D.  Public health and insomnia: economic impact.  Sleep 2000;3:S69-76. 
40. Gottschlich MM, Jenkins ME, Mayes T, et al.  A prospective clinical study of the 
polysomnographic stages of sleep following burn injury.  J Burn Care Rehabil 
1994;15:486-492. 
41. Mayes T, Gottschlich M, Khoury J et al. An evaluation of sleep efficiency in children 
during the rehabilitative phase of burn injury.  J Burn Care Res 2011;32:561. 
42. Gottschlich MM, Mayes T, Khoury J, Simakajornboon N, Kagan RJ.  Comparison of sleep 
parameters obtained from actigraphy and polysomnography during the rehabilitative 
phase postburn.  J Burn Care Res 2013;34:183-190. 
43. Mayes T, Gottschlich MM, Khoury J, McCall J, Simakajornboon N, Kagan RJ.  A pilot 
review of the long term impact of burn injury on sleep architecture in children.  J Burn 
Care Res, 2013;34:e15-e21. 
44. Jenkins M, Gottschlich M, Khoury J, et al.  Physiological variations during sleep in the 
acute postburn period.  Proc Am Burn Assn 1996;28:139. 
45. Jenkins ME, Gottschlich M, Khoury J, et al.  Sleep disruption in the pediatric burn ICU 
patient.  Proc Am Burn Assn 1994;26:51.        
46. Gottschlich MM, Mayes T, Allgeier C, et al.  Effect of sleep on C-reactive protein levels 
among children recovering from acute burns. J Burn Care Res 2008;29:S93. 
47. Jenkins ME, Gottschlich M, Khoury J, Warden GD.  An evaluation of white noise as an 
adjunct to sleep promoting intervention in pediatric burn patients.  J Burn Care Rehabil 
2002;23:S86. 

 
                                                                      26                                   Sleep 7 IRB – Version 2.1 
         
48. Armour A, Khoury J, Kagan RJ, Gottschlich MM.  Clinical assessment of sleep among 
pediatric burn patients does not correlate with polysomnography.  J Burn Care Res 
2011;32:529-534. 
49. Weinhouse GL, Schwab RJ.  Sleep in the critically ill patient.  Sleep.  2006;29:707-716. 
50. Rose M, Sanfor A, Thomas C, Opp MR.  Factors altering the sleep of burned children.  
Sleep 2001;24:45-51. 
51. Rechtschaffen A, Gilliland MA, Bergmann BM, Winter JB.  Physiological correlates of 
prolonged sleep deprivation in rats.  Science 1983;221:182-184. 
52. Brown R, Pang G, Husband AJ, King MS.  Suppression of immunity to influenza virus 
infection in the respiratory tract following sleep disturbance.  Reg Immunol 1989;2:321-
325. 
53. Brown R, Price RJ, King MG, Husband AJ.  Interleukin -1ß and muramyl dipeptide can 
prevent decreased antibody response associated with sleep deprivation.  Brain Behav 
Immun 1989;3:320-330. 
54. West LJ, Janszen HH, Lester BK, Cornelisoon FS. The psychosis of sleep deprivation.  
Ann NY Acad Sci 1962;96:66-70. 
55. Kramer M, Kinney L.  Sleep patterns in trauma victims with disturbed dreaming.  Psychiatr 
J Univ Ottawa 1988;13:12-16. 
56. Raymond I, Nielsen TA, Lavigne G et al. Quality of sleep and its relationship to pain 
intensity in hospitalized adult burn patients.  Pain 2001;92:381-388. 
57. Raymond I, Ancoli-Israel S, Choiniere M.  Sleep disturbances, pain and analgesia in 
adults hospitalized for burn injuries.  Sleep Medicine 2004;5:551-559. 
58. Bonnet MH, Berry RB, Arand DL.  Metabolism during normal fragmented and recovery 
sleep.  J Applied Physiol 1991;71:1112-1118. 
59. Moore RY.  Circadian rhythms: Basic neurobiology and clinical application.  Annu Rev 
Med 1997;48:253-266. 
60. Barion A, Zee PC.  A clinical approach to circadian rhythm sleep disorders.  Sleep 
2007;8:566-577. 
61. Zeitzer JM, Dijk DJ, Kronauer RE et al. Sensitivity of the human circadian pacemaker to 
nocturnal light: Melatonin phase resetting and suppression. J Physiol. 2000;526:695-702. 
62. Topf M, Davis JE.  Critical care noise and rapid eye movement (REM).  Heart Lung 
1993;22:252-258. 
63. Aaron JN, Carlisle CC, Carskadon MA et al.  Environmental noise as a cause of sleep 
disruption in an intermediate respiratory care unit. Sleep 1996;19:707-710. 
64. Al-Samsam RH, Cullen P.  Sleep and adverse environmental factors in sedated 
mechanically ventilated pediatric intensive care patients. Pediatr Crit Care Med 
2005;6:562-567. 
65. Krachman SL, D’Alonzo GE, Criner GJ.  Sleep in the intensive care unit.  Chest 
1995;107:1713-1720. 
66. McIntyre IM, Norman TR, Burrows GD et al.  Human melatonin response to light at 
different times of the night.  Psychoneuroendocrinol 1989;14:187-193. 
67. Vaughn GM, Pelham RW, Pang SF et al.  Nocturnal elevation of plasma melatonin and 
urinary 5- hydroxy-indole-acetic acid in young men: Attempts at modification by brief 
changes in environmental lighting and sleep and by autonomic drugs.  J Clin Endocrin 
Metab 1976;42:752-764. 
68. Lewy AJ, Wehr TA, Goodwin FK et al.  Light suppresses melatonin secretion in humans.  
Science 1980;210:1267-1269. 
69. Kanematsu N, Honma S, Katsuno Y et al. Immediate response to light of rat pineal 
melatonin rhythm: Analysis by in vivo microdialysis. Am J Physiol 1994;266:R1849-
R1855. 
70. Lynch HJ, Wurtman RJ, Moskowitz MA et al.  Daily rhythm in human urinary melatonin.  
Science 1975;187:169-171. 

 
                                                                      27                                   Sleep 7 IRB – Version 2.1 
         
71. Satoh K, Mishima K.  Hypothermic action of exogenously administered melatonin is dose-
dependent in humans.  Clin Neuropharmacol 2001;24:334-340. 
72. Cajochen C, Krauchi K, Wirz-Justice A.  Role of melatonin in the regulation of human 
circadian rhythms and sleep. J Neuroendocrinol 2003;14:432-437. 
73. Olofsson K, Alling C, Lundberg D, Malmros C. Abolished circadian rhythm of melatonin 
secretion in sedated and artificially ventilated intensive care patients.  Acta Anaesthesiol 
Scand 2004;48:679-684. 
74. Gogenur I, Middleton B, Kristiansen VB et al.  Disturbances in melatonin and core body 
temperature circadian rhythms after minimal invasive surgery. Acta Anaesthesiol Scand 
2007; 51:1099-1106. 
75. Mayes T, Gottschlich MM, Khoury J, McCall J, Simakajornboon N, Kagan RJ.  Sleep 
apnea: A risk factor for obese burned children during the rehabilitative phase of injury.  J 
Burn Care Res 2011;32:541-546. 
76. Stubbs K, Palmieri TL, Gottschlich M et al.  A longitudinal evaluation of the perceived 
quality of sleep in pediatric burns: A multicenter study. J Burn Care Rehabil 2008;29:S61. 
77. Stubbs TK, Lee AF, Gottschlich MM et al.  Association between quality of sleep and   
reaction to stress in 5 to 18 year old burned children: Implications for Care.  J Burn Care 
Res 2009;30:S80. 
78. Stubbs TK, Lee AF, Gottschlich MM et al.  Determining the probability of sleep problems 
in pediatric burns: The multicenter benchmarking study.  J Burn Care Res 2009; 
30:S108. 
79. Low AJF, Dyster-Aas J, Kildal M, et al. The presence of nightmares as a screening tool 
for symptoms of post-traumatic stress disorder in burn survivors.  J Burn Care Res 
2006;27:727-733. 
80. Suratt PM, Barth JT, Diamond R et al.  Reduced time in bed and obstructive sleep-
disordered breathing in children are associated with cognitive impairment.  Pediatrics 
2007;119:320-329. 
81. Chervin RD, Ruzicka DL, Giordani BJ et al.  Sleep-disordered breathing, behavior, and 
cognition in children before and after adenotonsillectomy.  Pediatrics 2006;117:e769-
e778. 
82. Torelli F, Moscufo N, Garreffa G et al.  Cognitive profile and brain morphological 
changes in obstructive sleep apnea.  Neuro Image 2011;54:787-793. 
83. Hagewoud R, Havekes R, Novati A et al.  Sleep deprivation impairs spatial working 
memory and reduces hippocampal AMPA receptor phosphorylation. J Sleep Res 
2010;19:280-288. 
84. Montgomery-Brown HE, Crabtree VM, Gozal D.  Cognition, sleep and respiration in at-
risk children treated for obstructive sleep apnoea.  Eur Respir J 2005; 25:336-342. 
85. Beebe DW, Ris MD, Kramer ME et al.  The association between sleep disordered 
breathing, academic grades and cognitive and behavioral functioning among overweight 
subjects during middle to late childhood.  Sleep 2010;33: 1447-1456. 
86. Mayes T, Gottschlich MM, Khoury J, et al.  Quantity and quality of nocturnal sleep impact 
morning glucose measurement in acutely burned children.  J Burn Care Res 2013; 
34:483-491. 
87. Stockman C, Spigarelli MG, Healy D, Gottschlich M, Buterbaugh W, Kagan R, Balch A, 
Sherwin CMT. Application of a method used to deconstruct a single dose 
pharmacokinetic profile from multiple dose data.  Biopharmaceutics and Drug Disposition 
(accepted for publication February 22, 2015). 
88. Stockmann C, Sherwin CMT, Buterbaugh W, Spigarelli MG, Gottschlich MM, Healy D, 
Kagan RJ. Zolpidem as a sleep-enhancing agent used in the treatment of severely 
burned children.  Ther Drug Monit. 2014; 36:295-301. 

 
                                                                      28                                   Sleep 7 IRB – Version 2.1 
         
89. Li L. Permuted-block randomization with varying block sizes using SAS® Proc Plan.  
http://analytics.ncsu.edu/sesug/2011/PO21.Li.pdf 
90. Jonas WB, Chez RA. The role and importance of definitions and standards in healing 
research.   Alternative Therapies 2003;9:A5-A9. 
91. Crawford CC, Jonas W, Nelson R et al. Alterations in random event measures associated 
with a healing practice. J Altern Complement Med 2003;3:35-353. 
92. Hawk C, Long CR, Reiter R et al. Issues in planning a placebo-controlled trial of manual 
methods: results of a pilot study. J Altern Complement Med 2002;8:21-32. 
93. Sikorskii A, Wyatt G, Victorson D et al. Methodological issues in trials of complementary 
and alternative medicine interventions. Nursing Research 2009;58:444-451. 
94. Ai AL, Peterson C, Gillespie B et al. Designing clinical trials on energy healing: Ancient 
art encounters medical science. Alternative Therapies 2001;7:83-90. 
95. Brown CK. Methodological problems of clinical research into spiritual healing: the healer’s 
perspective.  J Alternative Complementary Medicine. 2000:6:171-176. 
96. McDonough-Means SI, Kreitzer MJ, Bell IR. Fostering a healing presence and 
investigating its mediators. J Alternative Complementary Medicine. 2004;10:S25-S41. 
97. Healing Touch Level 1 Notebook.  Official Notebook for the Healing Touch Certifications 
Program.  7th Edition, April 2014. 
98. The AASM Manual for the Scoring of Sleep and Associated Events: Rules, Terminology, 
and Technical Specification.  Iber C, Ancoli-Israel S, Chesson A, Quan SF, editors. 1st 
ed. Westchester, IL: American Academy of Sleep Medicine; 2007. 
99. Barone M, Jenkins ME, Warden GD.  The development of an observational pain 
assessment scale (OPAS) for pediatric burns.  Proc Am Burn Assn 2000;32:249. 
100. Kain ZN, Mayes LC, Cicchetti DV et al.  Measurement tool for preoperative anxiety in 
young children: The Yale preoperative anxiety scale.  Child Neuropsychology 
1995;1:203-210. 
101. McCall JE, Stubbs K, Saylors S et al.  The search for cost-effective prevention of 
postoperative nausea and vomiting in the child undergoing reconstructive burn surgery: 
ondansetron versus dimenhydrinate.  J Burn Care Rehab 1999;20:309-315. 
102. Kain ZN, Mayes LC, Cicchetti DV et al. The Yale preoperative anxiety scale: how does 
it compare with a “Gold Standard”? Anesthe Analg 1997;85:783-788. 
103. Sikich N, Lerman J. Development and psychometric evaluation of the pediatric 
anesthesia emergence delirium scale.  Anesthesiology 2004; 100:1138-45. 
104. Olsen MK, Stechuchak KM, Edinger JD, Ulmer CS, Woolson RF. Move over locf: 
Principled methods for handling missing data in sleep disorder trials. Sleep Medicine. 
2012;13:123-132. 
105. Sterne JA, White IR, Carlin JB et al. Multiple imputation for missing data in 
epidemiological and clinical research: Potential and pitfalls. BMJ. 2009;338:b2393. 
106. Little RJA. Test of missing completely at random for multivariate data with missing values. 
Journal of the American Statistical Association. 1988;83:5. 
107. Little RJA. RDB. Statistical Analysis with Missing Data.  New York: John Wiley & Sons; 
2002. 
108. Williams R, Karacan I, Hursh C.  Electroencephalography (EEG) of Human Sleep: Clinical 
Applications.  New York, NY.  John Wiley; 1974.