The Effects of Healing Touch on Post Operative Pediatric Patients

NCT ID: NCT01738308

Last Updated: 2021-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2017-06-30

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.

Conditions

Surgery; Stress; Pain; Children; Post-Traumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Healing Touch Treatment

Healing Touch Treatment

When enter PACU + usual standard of care.

The Healing Touch practitioner will be at the bedside when the patient is first brought to the PACU. The HT practitioner will center and then attune with the child, connecting their energy with the child and setting the intention for healing for the child's highest good. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. The practitioner will hold this position until they feel a deep connection and "quieting" within the patient's energy. When the patient is awake and parents have been called to the bedside the HT practitioner will energetically ground and release the patient,

Group Type: EXPERIMENTAL

Healing Touch

Intervention Type: PROCEDURE

When enter PACU + usual standard of care.

The Healing Touch practitioner will be at the bedside when the patient is first brought to the PACU. The HT practitioner will center and then attune with the child, connecting their energy with the child and setting the intention for healing for the child's highest good. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. The practitioner will hold this position until they feel a deep connection and "quieting" within the patient's energy. When the patient is awake and parents have been called to the bedside the HT practitioner will energetically ground and release the patient,

Sham Healing Touch Treatment

Usual standard of post operative care plus a sham Heal Touch treatment upon entering the post anesthesia care unit. Treatment done by untrained study staff using same hand locations.

Group Type: SHAM_COMPARATOR

Healing Touch Sham Treatment

Intervention Type: PROCEDURE

The untrained in energy work study staff will be at the bedside when the patient is first brought to the PACU. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. This will continue until parents are called to the bedside

Control- No treatment done

Usual standard of post operative care with no additional intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Healing Touch

When enter PACU + usual standard of care.

The Healing Touch practitioner will be at the bedside when the patient is first brought to the PACU. The HT practitioner will center and then attune with the child, connecting their energy with the child and setting the intention for healing for the child's highest good. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. The practitioner will hold this position until they feel a deep connection and "quieting" within the patient's energy. When the patient is awake and parents have been called to the bedside the HT practitioner will energetically ground and release the patient,

Intervention Type: PROCEDURE

Healing Touch Sham Treatment

The untrained in energy work study staff will be at the bedside when the patient is first brought to the PACU. The practitioner will then place one hand on the center of the patient's chest in the "high heart" area. This will continue until parents are called to the bedside

Intervention Type: PROCEDURE

Other Intervention Names

Energy Therapy; Reiki; Presence

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Holistic Nurses Association (AHNA)

UNKNOWN

Sponsor Role: collaborator

Carolyn Stoll Research Fund (Cincinnati Childrens Hospital)

UNKNOWN

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Grace K Rolf, MSN CHTP AHN

Role: PRINCIPAL_INVESTIGATOR

Cincinnati Childrens

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2011-1572

Identifier Type: -

Identifier Source: org_study_id