Teaching Parents Reiki for Their Adolescents Receiving Palliative Care
Phase: NA
Conditions: Palliative Care, Chronic Disease
Sponsor: Ohio State University

Protocol Cover/Title Page 
 
 
 
Teaching Parents Reiki for Their Adolescents Receiving Palliative Care 
 
NCT03896165 
 
April 8, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Synopsis (one page) 
 
Study Title: Teaching Parents Reiki for Their Adolescents Receiving Palliative Care 
 
Study Design 
PICOT: 
P: Parents and adolescents receiving palliative care 
I: Teaching parents Reiki for use in the home 
C: None 
O: Primary: The primary outcome for the proposed study is the feasibility and acceptability of teaching Reiki to 
parents of adolescents receiving palliative care. Secondary outcomes include: adolescent global health, pain 
interference, medication use, and stress measures of hair cortisol (chronic, long term) and alpha amylase 
(immediate, short term); and parent symptom profile (depression, anxiety, physical function, pain interference, 
fatigue, sleep disturbance and ability to participate in social roles and activities), and stress measures of hair 
cortisol (chronic, long term) and alpha amylase (immediate, short term). 
T: Nine weeks from consent through follow up 
This intervention is easily implemented across a wide range of geographically dispersed settings. Reiki is 
a popular complementary health approach across the United States. There are Reiki practitioners in every state 
according to The International Center for Reiki Training,1 the largest organization of Reiki practitioners in the 
country. With a tested protocol, manual, and training, this intervention could be taught to Reiki practitioners 
and then parents and other caregivers for a reasonably small cost. 
 
Significance 
Despite advances in the assessment and treatment of symptoms, including adolescents receiving 
palliative care, parents still report that their children suffer. Adolescents with life-threatening/life-limiting 
conditions, many of whom are developmentally delayed, experience many symptoms and have complex co-
morbidities requiring medical management.2–4 Many of these adolescents could benefit from complementary 
health approaches (CHAs) such as Reiki, a gentle light touch biofield energy therapy. Parents of adolescents 
receiving palliative care also experience high levels of stress.5,6 Previous studies have shown that empowering 
parents in the care of their chronically ill child helps parents better cope with challenges.7–9 Preliminary evidence 
showed that professionally-delivered Reiki is feasible for children and adolescents receiving palliative care at 
home.10 The majority of parents in that study said they wished they could learn Reiki so they might provide this 
relaxing therapy in the moment it was needed rather than waiting for the next professional session. 
Teaching parents Reiki has the potential to impact both the child and the parent. Studies with adults 
have found that professionally-delivered Reiki decreased pain, anxiety, and other symptoms.11 Parents like to 
feel empowered in caring for their very ill children11,14 and doing so may decrease parental stress and other 
symptoms.13 The National Center for Complementary and Integrative Health (NCCIH) considers Reiki to be safe, 
although little scientific evidence exists about the effectiveness of this intervention.14 The proposed study 
addresses NINR priorities of advancing symptom science to “develop [and] test … novel, scalable symptom 
management interventions, including CHAs, in real-world clinical settings to improve health outcomes and 
quality of life”15(p.15)  and the science of compassion to improve palliative and end-of-life care through 
“developing, testing, and implementing personalized, culturally congruent, and evidence-based palliative and 
hospice interventions . . . that best address the needs of underserved, disadvantaged, and diverse populations 
across the care continuum.”15(p. 31) A long-term bonus of teaching parents to deliver Reiki is that once learned, 
Reiki is highly scalable and costs nothing to use, an important potential overall cost savings over other CHAs. 
 
Study Schema  
See Appendix 2. 

1 
Background and Rationale 
Despite advances in the assessment and treatment of symptoms, including pain in adolescents receiving 
palliative care, parents still report that their children suffer. Advances in medical science and care have led to a 
growing number of children living with life-limiting chronic conditions. Out of 83 million children under the age 
of 19,16 an estimated 600,000 to 1,600,00017 are living with life-threatening/life-limiting conditions and over 
180,000 are considered “medically fragile.”18 These children require intense medical and nursing care in the 
home and often experience lengthy, recurrent hospital stays, accounting for about 26% of hospital days and 41% 
of hospital charges.19 Adolescents with life-threatening/life-limiting conditions, many of whom are 
developmentally delayed, experience many symptoms and have complex co-morbidities requiring medical 
management.2–4  
Many of these adolescents could benefit from complementary health approaches (CHAs) such as Reiki, a 
gentle light touch biofield energy therapy. Parents of adolescents receiving palliative care also experience high 
levels of stress.5,6 Previous studies have shown that empowering parents in the care of their chronically ill child 
help parents better cope with challenges.7–9 Some CHAs show promise for symptom management without side 
effects, such as sedation from additional medication, thereby permitting greater alertness and allowing more 
interaction with family and friends.20,21 Preliminary evidence from the PI’s pilot study showed that 
professionally-delivered Reiki is feasible for children and adolescents receiving palliative care at home.10 The 
majority of parents said they wished they could learn Reiki so they might provide this relaxing therapy in the 
moment it was needed rather than waiting for the next professional session. One non-experimental program 
found that teaching parents Reiki was feasible and acceptable in the hospital. Parents who participated in two or 
more training sessions felt more confident providing Reiki.12 During informal interviews, parents said they felt 
good at being an active participant in their child’s care and that their child experienced increased comfort, 
relaxation, and decreased pain.12  
Parents of disabled adolescents receiving palliative care often suffer from high caregiver burden and 
chronic stress, leading to co-morbidities and decreased QoL. A cross-sectional survey conducted in Europe 
examined stress in 818 parents caring for a child with cerebral palsy.22 Results showed that 26% of mothers had 
very high stress. When the child had a communication or intellectual impairment or moderate-to-severe pain, 
parental stress was higher.22 Khanna et al. examined psychological burden for 204 parents of children with 
serious chronic conditions.23 This study found that 75% of parents reported depression, and 67% had anxiety. 
We are interested in exploring whether adding a skill (Reiki) aimed at decreasing symptoms in the adolescent 
will result in a decrease in symptoms and chronic stress for the parent. 
Teaching parents Reiki has the potential to impact both the child and the parent. Studies with adults 
have found that professionally-delivered Reiki decreased pain, anxiety, and other symptoms.11 Parents like to 
feel empowered in caring for their very ill children11,14 and doing so may decrease parental stress and other 
symptoms.13 Reiki is non-invasive and can therefore be used with anyone. The National Center for 
Complementary and Integrative Health (NCCIH) considers Reiki to be safe, although little scientific evidence 
exists about the effectiveness of Reiki.14 The proposed study addresses NINR priorities of advancing symptom 
science to “develop [and] test … novel, scalable symptom management interventions, including CHAs, in real-
world clinical settings to improve health outcomes and quality of life”15(p.15)  and the science of compassion to 
improve palliative and end-of-life care through “developing, testing, and implementing personalized, culturally 
congruent, and evidence-based palliative and hospice interventions . . . that best address the needs of 
underserved, disadvantaged, and diverse populations across the care continuum.”15(p. 31) A long-term bonus of 
teaching parents to deliver Reiki is that Reiki is highly scalable and once learned, costs nothing to use, an 
important potential overall cost savings over other CHAs. 
 
 

2 
Aims and Objectives 
AIM 1. Establish the feasibility and acceptability of teaching parents Reiki in the home to use with their 
adolescent receiving palliative care.  
AIM 2. Explore adolescents’ and parents’ stress response and symptom profile (i.e., physical function, 
anxiety, depression, fatigue, sleep, social roles, pain level, and biologic hair and saliva markers).  
AIM 3. Explore parents’ confidence in delivering Reiki and beliefs in their ability to help their adolescent. 
We will achieve these aims by enrolling 12 community-dwelling adolescent-parent dyads receiving 
palliative care at home. Teaching parents Reiki is highly innovative and may provide a novel, easily scalable 
method of promoting self-management of symptoms.  
 
3 
Study Design 
This study is a mixed methods quasi-experimental one group design.  
Parents of hospitalized ill children have been successfully taught to do Reiki with their children. 
However, no study that we are aware of has taught parents of community-dwelling children or adolescents 
receiving palliative care, nor has any study taught parents of these adolescents in a prospective, scientific 
manner. As such, a one-group feasibility, acceptability study design is appropriate to examine teaching parents 
Reiki one-on-one in the home using a short teaching period and booster session. The design and sample size will 
achieve the goals of the study, including preliminary symptom outcome measures and parental feelings about 
learning Reiki and providing this intervention to their adolescents. 
 
 
3.1 Study population 
Adolescent-parent dyads will be recruited in three ways: (1) at an outpatient appointment with the 
palliative care team; (2) during an inpatient hospitalization; or (3) by mailing a letter, pamphlet, and opt-in/opt-
out postcard or emailing a letter and pamphlet to the parent and follow-up with up to three phone calls or 
emails to introduce the study. For two parent households, parents will need to decide which parent provides at 
least some care for the adolescent and will perform the bulk of the Reiki sessions. The parent will provide 
written consent and the adolescent will provide written or verbal assent if able. If the adolescent is 
developmentally delayed he/she may not be asked to provide written assent/consent. The decision of 
documented assent/consent will be determined by the judgment of the parent in conjunction with the clinical 
judgment of the Palliative Care Center. Whenever developmentally appropriate, the adolescent’s 
assent/consent should be solicited through simple explanations, questions, and cues and his/her refusal 
respected. 
 
3.1.1 Eligibility criteria  
Participants will include adolescent-parent dyads receiving care through a palliative care service. We are 
using the World Health Organization definition of adolescent of ages 10-19 years. We will refer to this age group 
as adolescent throughout this protocol. Dyads will be included if the adolescent: (1) is 10 to 19 years old; (2) 
understands English; (3) has a prognosis of at least 2 months; and (4) if the parent/legal guardian provides at 
least some care for the adolescent most days of the week and is able to read and write English at the 8th grade 
level. Dyads will be excluded if (1) either the adolescent or the parent are taking or have taken any form of 
corticosteroids within the last 30 days (affects the HCC levels), or (2) either the adolescent or the parent has less 
than one inch of hair. Dyads will also be excluded if the adolescent resides in an inpatient facility, is in foster 
care/custody, or if the dyad does not have reliable means of storing samples at or below 32 degrees Fahrenheit.  
We intend to enroll participants regardless of sex, gender, or race. However, the sample size will be too 
small to analyze results based on these characteristics. 
 

3.1.2 Enrollment Details 
We will recruit parent-adolescent dyads who fit the inclusion/exclusion criteria. All adolescents will have 
a life-threatening or life-limiting illness and will be receiving palliative care. Some of the adolescents will be 
cognitively and/or developmentally delayed and will not be able to give assent to the study. Parents of these 
adolescents are very aware of their adolescent’s moods and symptoms and will choose to consent or not for the 
study with the best interest of their adolescent in mind. Data will be collected either on paper or using an iPad, 
depending on the participant preference and/or internet availability. Data will be collected either face-to-face 
(in the home or during an outpatient visit) or by phone depending on data to be collected and participant 
preference.  
 
3.2 Study measures and outcomes 
Table 1: Measures and Timing 
Variable 
(source) # = adolescent, * = parent 
T0: 
Enrollment 
T1: End of 
Intervention 
T2: 4-week 
Follow up 
Demographics#* 
X 
 
 
PROMIS Pediatric Global Health 7+2 or 
Parent Proxy Global Health 7+2#  
X 
X 
X 
PROMIS Pediatric Pain Interference or 
Parent Proxy  
Pain Interference#  
X 
X 
X 
Parent: (physical and emotional) PROMIS 29  
Symptom Profile* 
X 
X 
X 
Hair Sample Collection#* 
X 
 
X 
Parent Experience of Providing Reiki* 
 
 
X 
Saliva collection#* 
Pre/post 2 Reiki sessions per week during 
weeks 1-4 
Medication Log# 
Completed during weeks 0-4 
Parent intervention Log* 
Completed during weeks 1-4 
 
Demographic form (T0) basic demographic information on both parent and adolescent. 
Patient Reported Outcomes Measurement Information System (PROMIS), sponsored by the NIH. PROMIS 
Pediatric Pain Interference or PROMIS Parent Proxy SF Pain Interference,24,25 assesses how pain interferes with 
daily life for the adolescent. Well-validated measures show significant correlations between child and parent 
reports of pain.26 We will use the PROMIS Pediatric Global Health 7+2 measure to obtain an overall evaluation 
score of the adolescents’ physical and mental health. Both self-report and parent proxy versions are valid and 
reliable.27 Adult profile PROMIS 29 Symptom Profile (parent)28 assesses seven domains (depression, anxiety, 
physical function, pain interference, fatigue, sleep disturbance and ability to participate in social roles and 
activities).  
Medication Log documenting all pain medications given one week prior to and during the intervention period. 
Parent Intervention Log provided for parent record keeping. These logs will document Reiki session details, 
including the date, time, and length of session, interruptions to session, where the session took place, and 
parent comments and reactions (including adolescent reactions). 
Hair collection and assay: Hair cortisol concentration (HCC) is a measure of chronic stress. A recent study 
found that the mean cortisol level assayed in 1 cm of hair was correlated (r=0.61, p<0.01) with the mean 

salivary cortisol.29 A four-week follow-up period was chosen in order to obtain an accurate measure of 
HCC to determine any change in stress during the intervention period. Approximately 10-75 mg of hair30 is 
cut from the posterior vertex region of the scalp as close to the scalp as possible. The posterior vertex has 
the lowest variation in cortisol levels, and is the preferred area for sampling.31 Co-I (Ford) will train the PI 
and Co-I (Tate) on hair collection. We will take one cut at the first home visit (T0) and another at the four-
week follow-up home visit (T2). Assay: Each 1 cm of hair approximates the mean cortisol level over the 
prior 1 month.32 Samples are assayed in duplicate and inter- and intra-assay coefficients of variation 
calculated. HCC levels are expressed in hair as pg/mg. 
Saliva collection and assay: Salivary alpha amylase (sAA) is a non-invasive biomarker that detects 
immediate changes in autonomic nervous system response, signaling a change in level of stress.33,34 
Interventional studies have shown a decrease in sAA levels as a response to an intervention meant to 
stimulate relaxation.35,36 Collection: The Salimetrics Drool Tube for adults will be used for saliva collection 
from the parents and cognitively aware adolescents. The SalivaBio Swab for infants will be used for the 
remaining adolescents to eliminate any choking hazards. Samples will be collected for both parent and 
adolescent pre and post two Reiki sessions per week for four weeks. Storage: The swab will be placed in a 
Swab Storage Tube. Tubes will be put into a sealable plastic bag marked as parent or adolescent, the date 
and time of collection, and put into the home freezer until the PI or other team member collects them at 
the follow up visit. Samples will be transported on dry ice to the lab, and frozen at -20C until processed. 
Assay: The saliva samples will be batch processed after thawing using the Salimetric Alpha Amylase assay 
following manufacturer’s instructions. The amount of alpha-amylase activity present in the saliva sample 
is directly proportional to the increase in absorbance at 405 nm. 
The primary outcome for the proposed study is the feasibility and acceptability of teaching Reiki to 
parents of adolescents receiving palliative care. Secondary outcomes include: adolescent global health, pain 
interference, medication use, and stress measures of hair cortisol (chronic, long term) and alpha amylase 
(immediate, short term); and parent symptom profile (depression, anxiety, physical function, pain interference, 
fatigue, sleep disturbance and ability to participate in social roles and activities), and stress measures of hair 
cortisol (chronic, long term) and alpha amylase (immediate, short term). 
Because Reiki has not been taught to parents of adolescents receiving palliative care at home, we will 
determine the feasibility and acceptability of this intervention through calculating the percentage of dyads 
approached to the total participants who consented to participate in the study as well as completed the study. 
We will also conduct qualitative interviews with parents to examine what they thought of the teaching protocol, 
the usefulness of Reiki for stress and other symptoms, as well as their thoughts on the study as a whole. 
Secondary outcomes will be collected in order to explore preliminary evidence on overall health and quality of 
life as well as medication use for the adolescents and overall quality of life and symptoms of the parent.  
 
3.2.1 Study events description 
Dyads will be in the study for a total of nine weeks from enrollment to the follow-up visit. Screening 
occurs at least weekly and prior to enrollment. Enrollment and initial study measure completion, including first 
hair sample collection from both parent and adolescent, will occur at the beginning of Week 0. Parents will fill 
out the Medication Log during Week 0 in order to have a baseline of pain and anxiety medications before study 
intervention begins. The parent will receive Reiki training, a poster with suggested hand positions and a 
commercially-available book about Reiki in the home on the first day of Week 1. A visit window is defined as a 
week (7days) -1/+3 days from the initial Reiki training. During Week 2 the parent will receive a Reiki booster 
session with a repeat of the training and may ask questions. The parent will administer at least 5 times per week 
for at least 10 minutes each session. During weeks 1-4, the parent will collect saliva samples for themselves and 
their adolescent before and after any two Reiki sessions as long as they are collected on two separate days. At 
the end of Week 4, measures will be repeated either in person or by phone. During Week 8, measures will be 
repeated, the second hair sample obtained from both parent and adolescent, and the parent will participate in a 
qualitative interview. The qualitative interview will be administered in person by trained OSU College of Nursing 

study staff as part of the interview session. Interviews will be audio recorded using a hand-held audio recording 
device. Audio recordings will be transcribed verbatim. Audio recording is voluntary and participants can choose 
to not have their interview recorded and still be a part of the study. See Appendix 2 for schema. 
 
3.2.2 Exposure/Outcome measures and instruments  
The main data collection will occur during enrollment (T0), end of the intervention period, Week 4 (T1), 
and the follow up visit in Week 8 (T2). Parents will be instructed on how to collect and store alpha amylase saliva 
samples for themselves and their adolescent. Collection: The Salimetrics Drool Tube for adults will be used for 
saliva collection from the parents and cognitively aware adolescents. The SalivaBio Swab for infants will be used 
for the remaining adolescents to eliminate any choking hazards. Samples will be collected for both parent and 
adolescent pre and post any two Reiki sessions on two separate days per week for four weeks. Storage: The 
swab will be placed in a Swab Storage Tube. Tubes will be put into a sealable plastic bag marked as parent or 
adolescent, the date and time of collection, and put into the home freezer until the PI or other team member 
collects them at the follow up visit. Samples will be transported on dry ice to the lab, and frozen at -20C until 
processed. 
 
3.2.3 Data management 
Data will be collected using either paper measures or electronic measures via iPad per patient 
preference and/or internet availability. Data collected electronically will use Research Electronic Data Capture 
(REDCap) and entered by study staff into the study-specific electronic database for analysis. To minimize risks of 
disclosure of participants’ personal information, the study site will ensure management and protection of 
materials and information in compliance with national, state and institutional guidelines for protection of 
confidentiality of health-related research information. Any paper measures will be checked for completeness 
during collection by the study team member collecting the data. The Medication Log and the Parent 
Intervention logs will be paper only. Study staff will collect a snapshot of the de-identified medication log and 
intervention log periodically in coordination with study visits. If the Medication Log is blank, parents will be 
asked if they have given any pain or anxiety medications during the previous period and have the parent fill out 
the log if needed. If the Intervention Log is blank or does not contain at least 5 entries for the previous week, 
parents will be asked about Reiki sessions and will fill out the log if needed. Data collected on paper will be 
scanned and emailed to the PI via secure email when each participating dyad has completed the follow-up visit. 
Data entered from paper measures will be entered into a database using double data entry and checking. 
 
3.2.4 Compensation 
 
Each family will be given a total of $50 incentive payments, a $20 gift card at the first visit (includes initial 
measures and hair sample collection) and a $30 gift card at the follow up visit (also includes measures and hair 
sample collection). 
 
 3.3 Interventions 
This is a one-group feasibility study. There is only one intervention group. The Overall-Study PI and Local PI will 
recruit professional Reiki practitioners who are trained at Level 3 or Master Level and have prior experience 
working with families and children. A Reiki Master will perform the initial teaching and instruct the parent how 
to perform a simple 15-minute Reiki session. Parents will complete a return demonstration using light touch 
with their adolescent. The parent will receive an introductory book on Reiki, an informational article, and a 
poster showing hand positions for their reference as well as the intervention log to record sessions. The initial 
teaching session will take about 1.5 hours with breaks. The initial teaching session will be conducted by a Reiki 
Master and will mark the beginning of Week 1. A Reiki practitioner (Master or Level 3) will provide a shorter 
“booster” session the following week to review techniques with the parent and answer questions. This session 
will last 45 minutes with breaks. The “booster” session will count as one day for that week. Parents will be asked 

to complete a minimum of 15 minutes of Reiki with their adolescent at least five days per week for the four-
week intervention period. Parents will receive a phone call from the research coordinator once per week during 
weeks three and four to check in with them and ask if they have any questions or problems with the 
intervention and will refer to a Reiki practitioner if needed. 
 
4 
Statistics and Data Handling  
 
4.1 Statistical considerations 
Primary outcomes (Aims 1): Feasibility will be examined by computing the proportion of approached 
subjects enrolled in the study, the proportion of subjects who complete Reiki training, and the proportion of 
enrolled subjects’ who completed data collection. Qualitative data will be analyzed using a basic qualitative 
descriptive approach. Qualitative data (audio recorded interviews and field notes) will be transcribed verbatim, 
checked for accuracy, imported into Atlas.TI37 for data management, and analyzed.38 Portions of text are labeled 
or coded with terms that are descriptive of the user opinions and observations. Codes will be identified and 
defined in an iterative process by investigators independently coding the data and arriving at agreement in 
discussion/review. Codes are sorted and categorized into themes, which will be discussed in research meetings. 
We will use mixed methods to triangulate the qualitative and quantitative data to produce a more accurate 
picture of parental beliefs and experiences. These results will be used to refine procedures for future, larger 
studies. Qualitative results will be triangulated with quantitative results to answer questions of feasibility. 
Qualitative results will also be examined to explore the parents’ confidence in delivering Reiki and beliefs in their 
ability to help their adolescent (Aim 3). 
Secondary outcomes (Aim 2): Descriptive statistics will be used to check data distribution, identify 
outliers, examine the balance in baseline measurements, and report outcome measures (e.g. pain) at each time 
point. Trend plot will be used to visualize the trend of change over time. Pair-wise comparisons will be 
conducted to test the difference in the change in outcome measures (T0 versus T1, T1 versus T2, T0 versus T2) 
using two sample t-tests. We will not adjust for multiple comparisons to avoid further reduction of power. 
Mixed effect modeling for repeated measures will be used to examine the trajectories of treatment effect over 
time, adjusting for within-patient clustering from repeated measures and possible confounders.  
 
4.1.1 Sample size  
 
We will enroll 12 adolescent-parent dyads in order to achieve study objectives. The emphasis is on Aims 
1 and 3, the feasibility and acceptability of the study as well as the parents’ feelings about learning Reiki and 
their ability to help their adolescents. These aims will inform future study protocols. Aim 2 is exploring both 
parent and adolescent stress, symptoms, and overall quality of life. We are also testing data collection of hair 
and saliva in this population of adolescents receiving palliative care in the home. The preliminary results from 
the primary and secondary outcomes will inform the sample size of the next planned study, a two-group 
randomized controlled trial. 
 
 
4.2 Management of data 
 
4.2.1 Source documents [Site data management] 
Source documents are the original records of participant information. The ICH-GCP guidelines define 
source documents as "original documents, data, and records." Source documents may include study-specific 
Data Collection Tools (DCTs). DCTs are instruments/tools used to collect/document the requested data at each 
of the sites involved in the project.  The DCTs contain those variables listed in this protocol.   Examples of DCTs 
may include medication logs, Reiki log, research files, surveys and specific research worksheets used to 

document key research data elements. Consent forms (if applicable) and an enrollment log are kept at the sites 
to know which participants are being followed and to ensure accurate enrollment and comply with local IRB 
regulations. Source documents/DCTs remain at the site of collection. 
 
4.2.2 Data capture [Data management] 
Study site personnel will complete screening, enrollment, and make sure initial measures are complete. 
Site personnel will scan and email completed paper forms to the Overall PI via secure email transmission for 
double data entry or will enter data collected via research electronic data capture (REDCap). Any paper/scanned 
data will be entered into SPSS by the PIs undergraduate students who have been trained in double data entry 
and data checking. 
 
As part of the NIH data sharing directive, de-identified data from this study will be transferred to the PCRC Data 
Repository located at the University of Colorado. 
 
4.2.3 Record retention 
• 
Any study records (including DCTs, etc.) will be retained in the site’s research record for 10 years 
after the study is completed in accordance with Good Clinical Practice guidelines.  At that time the 
research information will be destroyed by each site’s research document destruction 
rules/regulations.   
• 
Any research information already included in medical records will be kept indefinitely. 
• 
The de-identified data that are collected and entered will remain in the PCRC Data Repository 
indefinitely. 
4.2.4 Data sharing [REQUIRED LANGUAGE] 
De-identified study data from this study will be transferred to the PCRC Data Repository located at the 
University of Colorado. The PCRC fully supports the Final NIH Statement on Sharing Research Data and will 
provide assistance to all investigators and personnel for compliance. Consistent with OMB Circular A-110 and 
subsequent NIH Grants Policy Statements, the PCRC will provide access to all de-identified data collected as part 
of PCRC-supported investigations, insofar as access is consistent with IRB/CHR rules, local, state, and Federal 
laws and regulations, and the HIPAA Privacy Rule. 
 
5 
Ethics and Dissemination 
 
5.1 Ethics and regulatory compliance 
We will submit this protocol and supporting documents (i.e., measures, consent) to the IRBs of Ohio 
State University (OSU) and Children’s Hospital. OSU will cede control of the study to Children’s Hospital IRB as 
the IRB of record per previous studies conducted at the same site with the same study team. We will seek 
additional language required by the PCRC for IRB applications and consent forms as well as advice from PCRC 
experts after funding. 
 
5.2 Confidentiality 
Every effort will be taken to ensure the confidentiality of study participants and their data. Only IRB-
approved study team members who have completed human subjects research training will have access to study 
data. All study data, with the exception of consent forms, will be identified by a code number only. Consent 
forms and the list linking study participant names and code numbers will be kept in a locked drawer in a locked 
office separate from other study data. Participants will be referred to by code number only. All reasonable effort 
will be made to maintain participant confidentiality. 

 
5.3 Data security 
The Ohio State University (OSU) College of Nursing has secure electronic data servers that are password 
protected and behind firewalls. All electronic data will be stored on these secure servers. Additionally, data sent 
electronically will be identified by code number only. Paper data, including consent forms, will be stored onsite. 
Consent forms and the list linking names and code numbers will be stored separately from other data. Audio 
recordings from the interview will be recorded using hand-held audio recording devices and the files transferred 
to password protected computers at OSU. These audio files will be identified with a subject ID only. Files are 
saved on the OSU College of Nursing server, which is password protected, regularly backed up, and only 
accessible by authorized study team members. Once the files are saved onto the computer, the file will be 
deleted from the recording device. Files may be kept on the server for up to 5 years. Only study personnel will 
have access to either paper or electronic data. 
 
6 
Safety Considerations 
 
6.1 Risks  
The risk of participating in this study are minimal. Reiki is non-invasive and can therefore be used with 
anyone. NCCIH considers Reiki to be safe although little scientific evidence exists about its effectiveness.14 There 
is the possibility that either the parent or adolescent may become uncomfortable during the Reiki session. If this 
happens, they should either take a break or change positions to be more comfortable. There is a risk for 
becoming tired or having pain due to the adolescent’s illness during the Reiki session. If either of these happens, 
the dyad should take a break and/or change positions to one that is more comfortable. Some of the data 
collection may be uncomfortable or inconvenient for the parent and/or adolescent. The hair sample collection 
may cause a slight physical discomfort due to the gentle pull on the hair before cutting and may cause social 
discomfort if the parent or adolescent feels as though the small bare spot on the scalp where the hair was 
clipped may show. Any study personnel who will be collecting hair will be trained to perform the sample cut 
gently and in a spot not likely to show. Collecting the saliva samples may be inconvenient for the parent as two 
samples must be collected (pre and post) for both the parent and adolescent (four samples total each time) 
twice per week for four weeks and stored in the home freezer. We will provide pre-labeled sample tubes and 
baggies so that the parent only has to add the date to each baggie in order to decrease the inconvenience as 
much as possible. 
 
Adverse Events. All adverse events (AEs) and serious adverse events (SAEs) will be tracked, 
documented, and reviewed. In one systematic review evaluating the efficacy of Reiki, nine randomized control 
trials reported no adverse events.49 It is anticipated that AEs in this study will be minimal. However, for the 
purpose of this study, AEs will be defined as clinically significant mental status changes, or any other unusual 
symptom or event (e.g. significant pain, a fall) that occur during the time frame of each Reiki session. An SAE will 
be defined as any untoward medical occurrence that results in death, is life threatening, results in 
hospitalization, or results in persistent or significant disability. Parent participants will be instructed to call the 
research coordinator for the study to report any adverse or unusual events. Parents will be instructed to call 911 
in the event of a medical emergency and report the emergency to the research coordinator or the palliative care 
on-call medical provider (physician or nurse practitioner) when they are able. In either case, the research 
coordinator will consult with one of the palliative care physicians or nurse practitioners immediately in the case 
of an SAE or within 24 hours of an AE. The PI of the study will be notified of all AEs and SAEs immediately via 
email for AEs and text message and email for SAEs. All AEs and SAEs will be reported to the IRB in a timely 
manner. 
 
 
 

6.2 Benefits 
The adolescent and/or parent may experience feelings of relaxation and/or decreased stress. 
 
6.3 Monitoring 
 
A. Study monitoring. 
Because this is a small, one-site, low-risk pilot study, the PI will be responsible for the ongoing 
evaluation of the progress of the proposed research study. The overall PI and local PI will ensure that all 
eligibility criteria and consent requirements are met prior to a participant’s participation and that all 
study procedures and AE reporting occur according to the IRB-approved protocol. The Ohio State 
University College of Nursing has created a Safety Monitoring Committee (SMC). This group will meet 
quarterly once recruitment has begun to review the study and any reports of untoward events and to 
monitor their resolution. Minutes will be kept of all meetings and following SMC meetings, the results of 
the meeting (meeting minutes) concerning possible negative side effects will be documented and sent 
to the Overall Study PI, Local PI, and the IRB. The local PI’s IRB will advise and monitor the design and 
implementation of all safety monitoring and risk management procedures. 
 
 B. Procedures: 
 
1) Monitoring study safety to include monitoring schedule, and auditing selected cases for compliance 
with IRB requirements, conformance with informed consent requirements, verification of source 
documents, and investigator compliance. 
 
Monitoring of study safety will occur monthly. Monitoring will begin with the first participant 
recruited. To ensure reliability of data entry, the Overall study PI will review a random sample of 
cases and compare the results with the information recorded in the database to monitor for 
compliance with IRB requirements. The Overall study PI will look at consent forms, data storage, and 
correct entries. An acceptable error rate is less than 3%, i.e., 3 per 100 entries. If error rate is more 
than 3%, the Overall study PI and a second member of the study team will recheck all data. 
 
Quality assurance reports will be prepared on a monthly basis by the Overall study PI and reviewed 
by Local PI. The reports will inform about missing, invalid, or inconsistent data on selected key 
variables such as age, sex, or diagnoses. The statistician on the project will oversee preparation of 
the reports. The reports will contain a summary of monthly accrual and cumulative accrual, a 
summary of key characteristics of the study participants, a summary of the completeness and 
quality of data. 
 
Quality assurance will involve engaging in good data management activities.  Procedures that 
include checking the integrity of data storage and examining frequency distributions to look for data 
anomalies. 
 
2) Minimizing research-associated risk: This study poses minimal risk to participants. 
 
Consent Procedures. Local PI, a research coordinator or another member of the study team will 
introduce the study to the adolescent and parent. Recruitment methods used by this palliative care 
center for previous studies will be used; these include approaching potential participants during 
regular clinic visits or mailing study information followed by up to three phone calls. If the study is 
introduced in the clinic, a member of the study team will introduce the study, and if the adolescent 
and parent are interested, a research coordinator will give more details about the study, go over the 

consent form, answer any and all questions. If by mail, interested participants who meet criteria will 
call the palliative care center and the research coordinator will mail a packet with the consent form 
and study information and will schedule a phone call to discuss the study. The research coordinator 
will meet with the parent and adolescent either in the clinic or in the home to go over the consent 
form. Any and all questions will be answered before the parent gives written consent and the 
adolescent gives written assent, or consent if age 18 or over, if able. Adolescent-parent dyads that 
meet eligibility criteria and give appropriate consent will be able to participate in the study. To 
protect participant confidentiality, the research coordinator will discuss consent in a private room at 
in the clinic, hospital room, or patient’s home. To prevent undue coercion, potential participants will 
be instructed that participation is completely voluntary, that their decision to participate will not 
affect their treatment, and that they may discontinue their participation in the study at any time. If 
the potential subject refuses to participate, there will be no further recruitment efforts but the 
subject will be asked about their reasons for refusal. 
 
Risk of measures:  It is possible that the adolescent or parent may become fatigued while 
completing consent or baseline measures that they may become fatigued. Participant burden was 
considered very carefully due to the nature of this study. Study measures to address the constructs 
were carefully chosen to minimize undue burden or fatigue. 
 
Fatigue. To minimize fatigue, the adolescent and parent will be offered breaks during the study 
procedures. Participants may choose to discontinue any procedure at any time for any reason. If at 
any point the adolescent or parent becomes fatigued or the adolescent requires attention, we will 
either take a break or stop altogether depending on the preference of the adolescent or parent.  
 
3) Protecting the confidentiality of participant data:  
 
Risk of breach of confidentiality: There is a possibility of risk of breach of confidentiality of protected 
health information. The Overall study PI and the Local PI will take all necessary steps to ensure that 
this does not happen. All participants will be assigned an ID code upon entry into the study. All 
records relating to the participant’s involvement in this research study will be stored securely within 
a locked office. Participant identities on these records are indicated by an ID code rather than by a 
name, and the file linking these ID codes with their identity are kept separate from the research 
records. Screening and enrollment logs will be kept securely password-protected on the server and 
de-identified when shared with Overall PI. Only the research coordinators will have the information 
to link the special ID codes to the participant’s names. The master list will be kept in a password 
protected file on the protected server. No information will be used in subsequent publications that 
would identify individual participants.  
 
This study does not involve evaluating drugs or devices. 
 
Adequacy of Protection Against Risks: Efforts will be taken to minimize the risk to breach of 
confidentiality of data and anonymity of the participants. All participants will be assigned a unique 
ID code number under which all data will be stored. Security of the data will be upheld through the 
use of password protection, encryption, and restricted access to users. Consent forms and a list of 
the match between participant names and code numbers will be retained securely in a locked office 
area. 
 
C. Procedures for identifying, reviewing, and reporting AEs and unanticipated problems to the IRB, funding 
sources, and FDA (if applicable). If applicable, the type and number of events that would halt accrual and 

would generate a review of eligibility, monitoring, assessments, intervention, and how the resumption 
of accrual would occur.  
 
Throughout the study the Overall study PI and Local PI will be responsible for monitoring participants for 
adverse events. The following will be considered SAEs: patient death, attempted suicide, major 
depression, or breach of confidentiality. The following will be considered AEs: patient allegations of 
physical/mental injury during the study, patient allegation of inappropriate consenting or recruitment 
procedures. The Overall study PI and Local PI will review AEs and unanticipated problems within 24 
hours of notification of the event. Unanticipated problems that are SAEs will be reported within one 
week of the investigator becoming aware of the problem.  Any other unanticipated problems should be 
reported within two weeks of the investigator becoming aware of the problem. All fatal or serious/life 
threatening AE will be reported to the IRB in accordance with IRB policy. Non-serious AEs will be 
reported to the IRB at time of continuing review. AEs determined as anticipated problems involving risks 
to subjects or others will be reported to IRB at time of continuing review. The Overall study PI and Local 
PI will be informed by team members about any AEs or unanticipated problems immediately. If protocol 
changes are needed, the research coordinator, with Overall study PI and Local PI approval, will submit a 
modification request to the IRB. Protocol changes will not be implemented prior to IRB approval unless 
necessary to eliminate apparent immediate hazards to the participants.   
 
At each meeting of the SMC during the conduct of the trial, the SMC will make a recommendation to the 
Overall study PI to continue or to terminate the trial. This recommendation will be based on safety 
considerations. The Overall study PI is responsible with the SMC for safeguarding the interests of 
participants and for the conduct of the trial. The Overall study PI will be responsible for deciding 
whether to continue or to stop the trial based on the SMC recommendations. 
 
D. For multi-site studies, procedures to ensure compliance with the monitoring plan and reporting 
requirements across study sites.  
 
This is a single site study. 
 
E. An assessment of external factors or relevant information (i.e., developments in the literature, results of 
related studies) that may have an impact of the safety of participants or on the ethics for the research 
study.  
 
The Overall study PI will be responsible for reviewing the literature monthly and reviewing with Local PI 
and inform the study team of any new developments related to the study that may have impact on the 
safety of participants or the ethics for the research study.  
 
F. The advanced plans for interim and/or futility analysis. 
 
An interim analysis will occur at six months after study initiation to determine whether enrollment is 
adequate or if a revision in recruitment strategies is needed and/or if the study appears to be futile (no 
participants recruited during six months of active recruitment). The Overall study PI together with Local 
PI will determine if early closure is justified if anticipated accruals cannot meet stated study goals.  
 
G. Description of how often monitoring entity meets, who will record proceedings, what group(s) receives 
SMC reports, and time period for completing reports should be specified.   
The Overall study PI, and Local PI and study staff will meet every two weeks either in person or by 
phone. The research coordinator will document meeting proceedings. The SMC will meet quarterly.  

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Appendices 
 
 
 
 

 
 
Appendix 1: Study Glossary 
 
Term 
Definition 
AE 
Adverse event 
CHA 
Complementary Health Approach 
CI  
Confidence interval 
DCT 
Data collection tools 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
IRB 
Institutional Review Board 
NCCIH 
National Center for Complementary and Integrative Health 
NIH 
National Institutes of Health 
OSU 
The Ohio State University 
PCRC 
Palliative Care Research Cooperative Group 
PROMIS 
Patient Reported Outcomes Measurement Information System 
PTES 
Perceived Treatment Efficacy Scale 
PI 
Principal Investigator 
QOL 
Quality of life 
RCT 
Randomized controlled trial 
SAE 
Serious adverse event 
T0 
Enrollment 
T1 
Week 4 
T2 
Week 8 
 
 
 
 
 
 
 

Appendix 2: Study Schema 
 
 
STUDY PERIOD 
# = adolescent 
* = parent 
Screening / 
Enrollment 
Intervention and Follow up Period 
TIMEPOINT 
 
(T0) 
Week 0  Week 1 
Week 2 
Week 3 
Week 4 
(T1) 
Week 8 
(T2) 
Eligibility screening #* 
X 
 
 
 
 
 
 
ENROLLMENT 
Informed consent/assent #* 
X 
 
 
 
 
 
 
INTERVENTION 
Initial Reiki teaching 
 
 
X 
 
 
 
 
Reiki teaching booster session  
 
 
 
X 
 
 
 
ASSESSMENTS 
Demographics #* 
X 
 
 
 
 
 
 
PROMIS Global Health 7+2 # 
X 
 
 
 
 
X 
X 
PROMIS Pain Interference # 
X 
 
 
 
 
X 
X 
PROMIS 29 Symptom Profile * 
X 
 
 
 
 
X 
X 
Hair Sample Collection #* 
X 
 
 
 
 
 
X 
Alpha Amylase #* 
 
 
X*2 
X*2 
X*2 
X*2 
 
Medication Log # 
 
X 
X 
X 
X 
X 
 
Qualitative Interview * 
 
 
 
 
 
 
X 
 
         
 
 
 
 
 

Appendix 3: Measures 
 
 

Demographic Data Form  
 
 
 
 
 
 
ID # ________ 
 
Adolescent: 
 
Where was the adolescent consented: Inpatient / outpatient clinic / home / other (circle one) 
 
Has the adolescent been hospitalized in the last month? Y/N (circle one) 
If yes, discharge date: ____________ 
 
Age in years: ______    Birthdate     __________ 
 
 
 
Sex: 
 
Unknown 
 
Male 
 
Female 
 
Not specified/Decline to answer 
 
Race: 
 
American Indian or Alaska Native 
 
 
Native Hawaiian or Pacific Islander 
 
Asian 
 
 
White 
 
Black or African American 
 
 
Unknown 
 
Ethnicity: 
 
Hispanic or Latino 
 
Not Hispanic or Latino 
 
Unknown 
 
Religion: 
 
Amish 
 
Jewish 
 
None 
 
Buddhist 
 
Catholic 
 
Other: _________________ 
 
Hindu 
 
Protestant/Christian*  
Decline to Answer 
 
Muslim 
 
(*includes Baptist, Presbyterian, Methodist, Lutheran, 
Episcopalian, Church of Christ, Pentecostal/Foursquare, 
Christian Science, Quaker, Unitarian, etc.) 
 
Spiritual but not 
religious 
 
Primary diagnosis that resulted in palliative or hospice referral 
_______________________________ 
Is the child developmentally delayed?   Yes _____No _____   
(as defined by parent report & PPC provider opinion) 
If yes, Diagnosis: ________________________ ICD-10 __________ 
Is the adolescent receiving palliative care?  Yes _____ No _____   
Date referred to palliative care:  _____/_____/________ 
Is the adolescent receiving hospice care?  Yes _____ No _____   
Where is care provided: _______________________ 
Date referred to hospice care:  _____/_____/________ 

Parent/Legal Guardian: 
 
Age     __________  
Sex     __________  
 
 
Race: 
 
American Indian or Alaska Native  
 
Native Hawaiian or Pacific Islander 
 
Asian 
 
 
White 
 
Black or African American 
 
 
Unknown 
 
Ethnicity: 
 
Hispanic or Latino 
 
Not Hispanic or Latino  
Unknown 
 
Current Marital Status: 
 
Single 
 
 
Widowed 
 
Married 
 
 
Living with romantic partner 
 
Divorced 
 
 
Decline to answer 
 
Employment: 
 
Part Time 
 
 
Family Medical Leave 
 
Full Time 
 
 
Homemaker 
 
Seasonal/occasional 
 
 
Retired 
 
Unemployed 
 
 
Decline to answer 
 
Educational Level: 
 
Less than high school 
 
 
Bachelor’s Degree 
 
High school 
 
 
Master’s Degree 
 
Some college 
 
 
Doctoral Degree 
 
Associates Degree 
 
 
Decline to answer 
 
Total number of people living in the household: _________ 
 
Total Family Income (yearly): 
 
< $10,000 
 
 
$60,000-79,999 
 
$10,000-19,999 
 
 
>$80,000 
 
$20,000-39,999 
 
 
Decline to answer 
 
$40,000-59,999 
 
 
 
 
Religion: 
 
Amish 
 
Jewish 
 
None 
 
Buddhist 
 
Catholic 
 
Other: _________________ 
 
Hindu 
 
Protestant/Christian*  
Decline to Answer 
 
Muslim 
 
(*includes Baptist, Presbyterian, Methodist, Lutheran, 
Episcopalian, Church of Christ, Pentecostal/Foursquare, 
Christian Science, Quaker, Unitarian, etc.) 
 
Spiritual but not 
religious 
 
 
 

 
 
PROMIS Pediatric Scale v1.0 – Global Health 7+2 
 
Pediatric Global Health 7+2 
 
Please respond to each question or statement by marking one box per row. 
 
Excellent 
Very 
Good 
Good 
Fair 
Poor 
Global01R1 
In general, would you say your 
health is:........................................
 
5 
 
4 
 
3 
 
2 
 
1 
Global02R1 
In general, would you say your 
quality of life is:............................ 
 
5 
 
4 
 
3 
 
2 
 
1 
Global03R1 
In general, how would you rate 
your physical health? .................... 
 
5 
 
4 
 
3 
 
2 
 
1 
Global04R1 
In general, how would you rate 
your mental health, including 
your mood and your ability to 
think? ............................................ 
 
5 
 
4 
 
3 
 
2 
 
1 
Never 
Rarely 
Sometimes 
Often 
Always 
PedGlobal2R1 
How often do you feel really 
sad? ...............................................
 
5 
 
4 
 
3 
 
2 
 
1 
Always 
Often 
Sometimes 
Rarely 
Never 
PedGlobal5R1 
How often do you have fun with 
friends? .........................................
 
5 
 
4 
 
3 
 
2 
 
1 
PedGlobal6R1 
How often do your parents listen 
to your ideas?................................ 
 
5 
 
4 
 
3 
 
2 
 
1 
In the past 7 days… 
Never 
Almost 
Never 
Sometimes 
Often 
Almost 
Always 
2876R1r 
I got tired easily ............................ 
 
1
 
2
 
3
 
4
 
5
3793R1r 
I had trouble sleeping when I 
had pain......................................... 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 
14 July 2016 
© 2010-2016 PROMIS Health Organization and PROMIS Cooperative Group 
Page 1 of 1 

PROMIS Parent Proxy Scale v1.0 – Global Health 7+2 
 
Parent Proxy Global Health 7+2 
 
Please respond to each question or statement by marking one box per row. 
 
Excellent 
Very 
Good 
Good 
Fair 
Poor 
Global01_PXR1 
In general, would you say your 
child's health is:..........................
 
5 
 
4 
 
3 
 
2 
 
1 
Global02_PXR1 
In general, would you say your 
child's quality of life is:.............. 
 
5 
 
4 
 
3 
 
2 
 
1 
Global03_PXR1 
In general, how would you rate 
your child's physical health?...... 
 
5 
 
4 
 
3 
 
2 
 
1 
Global04_PXR1 
In general, how would you rate 
your child's mental health, 
including mood and ability to 
think? ......................................... 
 
5 
 
4 
 
3 
 
2 
 
1 
Never 
Rarely 
Sometimes 
Often 
Always 
PedGlobal2_PXR1 
How often does your child feel 
really sad? ..................................
 
5 
 
4 
 
3 
 
2 
 
1 
Always 
Often 
Sometimes 
Rarely 
Never 
PedGlobal5_PXR1 
How often does your child 
have fun with friends? ...............
 
5 
 
4 
 
3 
 
2 
 
1 
PedGlobal6_PXR1 
How often does your child feel 
that you listen to his or her 
ideas? ......................................... 
 
5 
 
4 
 
3 
 
2 
 
1 
In the past 7 days… 
Never 
Almost 
Never 
Sometimes 
Often 
Almost 
Always 
Pf4fatigue3r 
My child got tired easily ............ 
 
1
 
2
 
3
 
4
 
5
Pf2pain5r 
My child had trouble sleeping 
when he/she had pain................. 
 
1 
 
2 
 
3 
 
4 
 
5 
 
 
 
 
 
 
 
 
5 May 2016 
© 2010-2016 PROMIS Health Organization and PROMIS Cooperative Group 
Page 1 of 1 

PROMIS® Pediatric Item Bank v1.0 – Pain Interference 
 
Pediatric Pain Interference 
 
Please respond to each item by marking one box per row. 
 
 
In the past 7 days. . . . . 
Never 
Almost 
Never 
Sometimes 
Often 
Almost 
Always 
1698bR1 
I felt angry when I had pain. 
 
0
 
1
 
2
 
3
 
4
 
2035R1 
I had trouble doing schoolwork when I 
had pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
3793R1 
I had trouble sleeping when I had pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
9004 
It was hard for me to pay attention when 
I had pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
2045R1 
It was hard for me to run when I had 
pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
2049R1 
It was hard for me to walk one block 
when I had pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
1703R1 
It was hard to have fun when I had pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
2180R1 
It was hard to stay standing when I had 
pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
3582R1 
I hurt a lot. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
9009 
I hurt all over my body. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
2032R1 
I missed school when I had pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
9007 
It was hard for me to remember things 
when I had pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
1701R1 
It was hard to get along with other 
people when I had pain. 
 
0 
 
1 
 
2 
 
3 
 
4 
 
 
 
© 2009-2012 PROMIS® Health Organization and PROMIS Cooperative Group 
Page 1 of 1 

PROMIS Parent Proxy Item Bank v1.0 – Pain Interference 
 
Pain Interference 
 
Please respond to each question or statement by marking one box per row. 
 
 
In the past 7 days… 
Never 
Almost 
Never 
Sometimes 
Often 
Almost 
Always 
Pf2pain5 
My child had trouble sleeping when 
he/she had pain ........................................... 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf3pain7 
My child felt angry when he/she had pain . 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf2pain2 
My child had trouble doing schoolwork 
when he/she had pain ................................. 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf3pain2 
It was hard for my child to pay attention 
when he/she had pain ................................ 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf2pain4 
It was hard for my child to run when 
he/she had pain .......................................... 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf1pain4 
It was hard for my child to walk one block 
when he/she had pain ................................ 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf3pain4 
It was hard for my child to have fun when 
he/she had pain .......................................... 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf4pain6 
It was hard for my child to stay standing 
when he/she had pain .................................. 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf4pain2 
It was hard for my child to remember 
things when he/she had pain...................... 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf4pain4 
It was hard for my child to get along with 
other people when he/she had pain ........... 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf4pain1 
My child hurt a lot ....................................... 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf3pain6 
My child hurt all over his/her body ........... 
 
0 
 
1 
 
2 
 
3 
 
4 
Pf4pain5 
My child missed school when he/she had 
pain ........................................................... 
 
0 
 
1 
 
2 
 
3 
 
4 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© 2008-2012 PROMIS Health Organization and PROMIS Cooperative Group 
Page 1 of 1 

PROMIS–29 Profile v2.0 
 
Please respond to each question or statement by marking one box per row. 
 
 
Physical Function 
Without 
any 
difficulty 
With a 
little 
difficulty 
With 
some 
difficulty 
With 
much 
difficulty 
Unable 
to do 
1 
Are you able to do chores such as 
vacuuming or yard work? .......................... 
 
 
 
 
 
2 
Are you able to go up and down stairs at a 
normal pace?.............................................. 
 
 
 
 
 
3 
Are you able to go for a walk of at least 
15 minutes?................................................ 
 
 
 
 
 
4 
Are you able to run errands and shop? ...... 
 
 
 
 
 
 
Anxiety 
In the past 7 days… 
Never 
Rarely 
Sometimes 
Often 
Always 
5 
I felt fearful................................................ 
 
 
 
 
 
 
6 
I found it hard to focus on anything other 
than my anxiety ......................................... 
 
 
 
 
 
7 
My worries overwhelmed me .................... 
 
 
 
 
 
8 
I felt uneasy ............................................... 
 
 
 
 
 
 
Depression 
In the past 7 days... 
Never 
Rarely 
Sometimes 
Often 
Always 
9 
I felt worthless ........................................... 
 
 
 
 
 
10 
I felt helpless.............................................. 
 
 
 
 
 
11 
I felt depressed........................................... 
 
 
 
 
 
12 
I felt hopeless............................................. 
 
 
 
 
 
 
Fatigue 
During the past 7 days… 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
13 
I feel fatigued ............................................. 
 
 
 
 
 
14 
I have trouble starting things because I 
am tired...................................................... 
 
 
 
 
 
 
 
 
 
 
 
Participant Format © 2008-2013 PROMIS Health Organization and PROMIS Cooperative Group 
Page 1 of 3 

PROMIS–29 Profile v2.0 
 
 
 
Fatigue 
In the past 7 days… 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
15 
How run-down did you feel on average? ... 
 
 
 
 
 
16 
How fatigued were you on average? .......... 
 
 
 
 
 
 
Sleep Disturbance 
In the past 7 days… 
Very poor 
Poor 
Fair 
Good 
Very good 
17 
My sleep quality was.................................. 
 
 
 
 
 
 
In the past 7 days… 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
18 
My sleep was refreshing............................. 
 
 
 
 
 
19 
I had a problem with my sleep .................. 
 
 
 
 
 
20 
I had difficulty falling asleep .................... 
 
 
 
 
 
 
Ability to Participate in Social Roles 
and Activities 
Never 
Rarely 
Sometimes 
Usually 
Always 
21 
I have trouble doing all of my regular 
leisure activities with others
 
 
 
 
 
22 
I have trouble doing all of the family 
activities that I want to do ....................... 
 
 
 
 
 
23 
I have trouble doing all of my usual work 
(include work at home) ........................... 
 
 
 
 
 
24 
I have trouble doing all of the activities 
with friends that I want to do .................. 
 
 
 
 
 
 
Pain Interference 
In the past 7 days… 
Not at all 
A little bit 
Somewhat 
Quite a bit 
Very much 
25 
How much did pain interfere with your 
day to day activities? .................................. 
 
 
 
 
 
26 
How much did pain interfere with work 
around the home? ....................................... 
 
 
 
 
 
27 
How much did pain interfere with your 
ability to participate in social activities? . 
 
 
 
 
 
28 
How much did pain interfere with your 
household chores? ..................................... 
 
 
 
 
 
 
 
 
 
 
 
 
Participant Format © 2008-2013 PROMIS Health Organization and PROMIS Cooperative Group 
Page 2 of 3 

PROMIS–29 Profile v2.0 
 
 
Pain Intensity 
In the past 7 days… 
29 
How would you rate your pain on 
average?.......................................... 
 
0 
 
1 
 
2 
 
3 
 
4 
 
5 
 
6 
 
7 
 
8 
 
9 
 
10 
 
No 
pain 
Worst 
imaginable 
pain 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Participant Format © 2008-2013 PROMIS Health Organization and PROMIS Cooperative Group 
Page 3 of 3 

INTERVIEW GUIDE 
Teaching Parents Reiki for Their Adolescents Receiving Palliative Care 
Interviews with parents can take place in a setting of their choosing. Assure that the risk for 
interruptions is minimized. 
Introductory Comments: 
We value your opinions as parents who have been engaged in symptom management with your child. 
We’d like to obtain some feedback about using REIKI therapy to help with those symptoms. All 
opinions and information shared here will be confidential and your participation is anonymous. We 
don’t share your names or your opinions by name or attach any identifying information to the 
transcript of this session. I will be recording this session if it’s OK with you. This is just to make sure I 
get an accurate record of your answers. We will listen to the recording and transcribe the words into 
text on the computer. No one will have access to your responses except study personnel. Do we have 
your permission to proceed with the recording?  
I have a series of questions I want to cover and these are open-ended questions so think of this more 
like a conversation than a questionnaire or a survey, and of course you are free to refuse to answer 
any questions or to stop the interview at any point.  But, really, feel free to raise any issues that you 
think are important or central to some of the things that we discuss today. We really designed the 
questions to try to address some of the areas we think are key to understanding how you used REIKI 
with your child. 
Also, I’m going to be using the word “child” even though ____ is an adolescent. Is that okay with 
you? 
Before we get started, do you have any questions or concerns? 
1. Tell me a little about your child. 
a. What kinds of symptoms are most distressing for your child? 
b. Can you describe how you manage those symptoms? Before REIKI? Please describe 
a typical day before the REIKI training. 
2. Tell me about the REIKI training. 
a. How long did it take to learn? 
b. How difficult was it for you to learn? What about the practice – was it enough to make 
you feel comfortable with your ability to administer REIKI to your child? 
c. Was there anything about the training that you think should be changed for other 
parents? 
3. So, you have had about 4 weeks to use REIKI with your child to help managing their 
symptoms. 
a. Can you describe how you typically use it? 
b. How often do you use it? 
c. How do you make the decision to use it? 
d. Would there be a situation that you might not use REIKI? 
e. Were there any particular symptoms that you felt were easier to manage using REIKI? 
f. Were there any symptoms that it just didn’t work for? 
g. Can you describe a situation where using REIKI was particularly effective? 

 
 
 
Pain and Anxiety Medication Log 
 
 
 
 
 
 
Subject ID _________ 
Date & 
Time 
Medication 
Dose 
Reason 
Comment 
/ / 
  
am/pm 
/ / 
  
am/pm 
/ / 
  
am/pm 
/ / 
  
am/pm 
/ / 
  
am/pm 
/ / 
  
am/pm 
/ / 
  
am/pm 
/ / 
  
am/pm 

 
Parent Intervention Log 
Subject ID   
 
 
 
Date 
Start 
Time 
Session 
Minutes 
Any Session 
Interruptions? 
Where did the session 
take place? 
Comments/Reactions to Session 

Version 1, February 4, 2019 
33