The Effects of Healing Touch on Post Operative Pediatric Patients
Investigating the Effect of Healing Touch on Post-Operative Recovery of Pediatric Tonsillectomies and Adenoidectomies Patients Ages 3 & 4
1 other identifier
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable surgery
Started Sep 2013
Longer than P75 for not_applicable surgery
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2012
CompletedFirst Posted
Study publicly available on registry
November 30, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 24, 2021
June 1, 2021
3.8 years
November 28, 2012
June 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Anxiety
1. Perioperative Adult Child Behavioral Interaction Scale (PABCIS) behavioral and self-assessments pre operatively and post-operatively by blinded research assistants. This scale is a behavioral assessment of the child/ adult behavioral interactions in the perioperative period. Parents will be asked to provide self-assessments of their distress in the preoperative and post-operative period. Parents will use Likert scales 2. Biologic measures: vital signs (B/P, pulse, and pulse oximetry) pre-operatively and sequentially post operatively done by PACU nurses. 3. 2 Weeks after surgery will do PHBQ (Post Hospital Behavioral Questionaire)to assess childs adaptation
Day of Surgery (pre and post surgery) & 2 Weeks following Surgery
Secondary Outcomes (1)
2. Emergence agitation/ emergence delirium
Day of Surgery
Other Outcomes (4)
3. Pain:
Day of Surgery
4. Time to wake up
Day of surgery
5. Length of stay in the PACU:
Day of Surgery
- +1 more other outcomes
Study Arms (3)
Healing Touch Treatment
EXPERIMENTALHealing 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,
Sham Healing Touch Treatment
SHAM COMPARATORUsual 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.
Control- No treatment done
NO INTERVENTIONUsual standard of post operative care with no additional intervention
Interventions
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,
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
Eligibility Criteria
You may qualify if:
- Typically developing
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wendy Grace K Rolf, MSN CHTP AHN
Cincinnati Childrens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2012
First Posted
November 30, 2012
Study Start
September 1, 2013
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 24, 2021
Record last verified: 2021-06