The Effects of Healing Touch on Post Operative Pediatric Patients (NCT01738308) | Clinical Trial Compass
CompletedNot Applicable
The Effects of Healing Touch on Post Operative Pediatric Patients
United States240 participantsStarted 2013-09
Plain-language 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.
Who can participate
Age range
3 Years – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
1. Anxiety
Timeframe: Day of Surgery (pre and post surgery) & 2 Weeks following Surgery
Trial details
NCT IDNCT01738308
SponsorChildren's Hospital Medical Center, Cincinnati