Clinical trial NCT01738308: The Effects of Healing Touch on Post Operative Pediatric Patients
Official title: Investigating the Effect of Healing Touch on Post-Operative Recovery of Pediatric Tonsillectomies and Adenoidectomies Patients Ages 3 & 4
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Stress
Pain
Children
Post-Traumatic Stress Disorder
Keywords: Healing Touch
Pediatrics
surgery
stress
pain
Pediatric Stress
maladaptive behaviors
energy medicine
emergence delirium
emergence agitation
length of stay
ease of wake up
distress parents
distress pediatric patients
Pediatric Post-Traumatic Stress Disorder
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: American Holistic Nurses Association (AHNA)
name: Carolyn Stoll Research Fund (Cincinnati Childrens Hospital)
First posted: 2012-11-30
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to assess the benefits of Healing Touch, an energy based therapy on post-operative discomfort and the rate of recovery in children. The aims of this study are to measure the effect of Healing Touch on post-operative: 1) anxiety, 2) emergence agitation/ emergence delirium (EAD), 3) pain, 4) time to wake-up, 5) time to meet PACU's departure criteria, 6.) maladaptive behaviors 2 weeks following surgery \& 7)readmissions for complications 2 weeks following surgery.

This is a triple blinded randomized controlled trial with three parallel groups. 240 subjects, ages 3 or 4 will be randomly assigned to receive the usual post-operative care, the usual care plus a post-operative Healing Touch treatment, or the usual post-operative care plus a sham Healing Touch treatment done by an untrained research assistant. The participants \& parents, the evaluators, and the principle investigator will be blinded to study group assignment.

Detailed description: ABSTRACT:

Tonsillectomies and adenoidectomies (T\&A) are the most commonly performed pediatric surgeries (NIH, 2010). Surgery is understandably anxiety provoking for children and for their families. Research has shown that anxiety influences post-operative recovery (Kain, 2004, 2012; Lynch, 1998; Schisler, 1998; Vaurio, 2006). Anxiety, emergence agitation and emergence delirium (EA/D) and pain during recovery from general anesthesia have been identified as frequent problems in the pediatric population, particularly with younger children (Key, 2010) and these have been related to increases in length of stay. Perioperative stress often has prolonged effects. After surgery, 88% of all children develop new-onset post-operative maladaptive behavioral changes. These changes refer to developmental regression and behaviors that interfere with daily functioning such as general anxiety, nighttime crying, enuresis, separation anxiety, night terrors, temper tantrums etc). Alarmingly, 54% of all children demonstrate maladaptive behaviors 2 weeks following surgery and 20% of these children continue to demonstrate negative behaviors 6 months postoperatively. Research has shown that younger children are at even higher risks (Kain, 2004; Watson, 2003).

Healing Touch is a biofield therapy that has been shown to decrease pain and anxiety in adults (Im, 2009; Jain, 2010) and in premature infants (Hanley, 2008; Im, 2009, Whitley, 2008). For several years Holistic Health Specialist Nurses trained in Healing Touch have been doing Healing Touch in Cincinnati Children's Hospital Medical Center's Post Anesthesia Care Unit (CCHMC's PACU). Nurses anecdotally have noted that patients who receive Healing Touch seem to wake up calmer, often need less pain medication and are less stressful after their surgeries. CCHMC nurses have reported that Healing Touch is especially useful with anxious children and younger children. Healing Touch (HT) is a complementary therapy that is a non-invasive, low-cost therapy without known side effects that can easily be incorporated into post-operative care routines.

The desired study outcomes in the Healing Touch treatment group are:

1. Lower anxiety levels, measured by differences in the Perioperative Adult Child Behavioral Interaction Scale(PACBIS) scores pre \& postoperatively. This is a behavioral assessment of the child's coping and distress and the parents positive and negative behavior. Parent will also self evaluated their distress and anxiety. The Healing Touch group will have a lower sympathetic response as measured by preoperative and sequential post-operative B/P, Pulse, Respirations, \& pulse oximetry
2. Less emergence agitation and delirium measured by the Pediatric Anesthesia Emergence Delirium (PAED)scores, an observational scale which will be done sequentially once they enter the recovery room
3. Less pain as measured by the Faces, Legs, Activity, Cry, and Consolability (FLACC) scale and significantly less pain medication usage
4. Waking up more slowly once they enter the PACU
5. Shorter length of stay in the PACU, measured by meeting PACU's discharge criteria.
6. Significantly less regression and maladaptive behaviors measured by the Post-Hospital Behavior Questionnaire (PHBQ) 2 weeks following surgery.
7. Fewer readmissions for complications 2 weeks following surgery as identified by family guardian in the 2 week follow up call.

The significance of this study is that its outcomes will add to the body of knowledge about the practice of Healing Touch with children, and may provide evidence substantiating the benefits of Healing Touch on post-operative pediatric patients. This may lead to the incorporation of Healing Touch into pediatric nursing practice. Preschool children are at higher risk for extended stressful responses to surgery, i.e. regression and maladaptive behaviors (Vernon, 1966). Preschoolers have vivid imaginations and magical thinking. They may have trouble telling fantasy from reality. The often develop fears related to new places and experiences and separation from parents. There have been no identified effective supportive measures to improve this protracted stress outcome. Healing Touch may be a tool that can comfort and support this vulnerable population and may be helpful with other hospitalized children.

Eligibility criteria: Inclusion Criteria:

Typically developing

* 3 or 4 years old
* elective tonsillectomy with or without adenoidectomy
* o American Society of Anesthesiologist Classification (ASA) I without systemic disease

  o American Society of Anesthesiologist Classification (ASA) II: moderate systemic disease
* Parents speak and write English

Exclusion Criteria:

* Emergency surgery
* have a complicating diagnosis or chronic medical illness
* A history of chronic pain or use of analgesic drugs.
* Familiar or personal history of malignant hyperthermia
* Previous surgeries or hospitalizations
* Parents unable to understand English

Primary outcomes:
measure: 1. Anxiety
timeFrame: Day of Surgery (pre and post surgery) & 2 Weeks following Surgery
Secondary outcomes:
measure: 2. Emergence agitation/ emergence delirium
timeFrame: Day of Surgery
Other outcomes:
measure: 3. Pain:
timeFrame: Day of Surgery
measure: 4. Time to wake up
timeFrame: Day of surgery
measure: 5. Length of stay in the PACU:
timeFrame: Day of Surgery
measure: 6. Maladaptive behaviors & ? Has patient needed to be readmitted to hospital for complications
timeFrame: 2 Weeks Post operativly
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Childrens
name: Wendy Grace K Rolf, MSN CHTP AHN
role: PRINCIPAL_INVESTIGATOR
References: