The Effects of Healing Touch on Post Operative Pediatric Patients



Status:Recruiting
Conditions:Chronic Pain, Psychiatric, Psychiatric
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology
Healthy:No
Age Range:3 - 4
Updated:4/21/2016
Start Date:September 2013
End Date:February 2016
Contact:Wendy Grace K Rolf, MSN
Email:wendy.rolf@cchmc.org
Phone:513-803-0071

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Investigating the Effect of Healing Touch on Post-Operative Recovery of Pediatric Tonsillectomies and Adenoidectomies Patients Ages 3 & 4

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.

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.

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
We found this trial at
1
site
3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Principal Investigator: Wendy Grace K Rolf, MSN
Phone: 513-736-2245
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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