The Effects of Healing Touch on Post Operative Pediatric Patients

Completed · Not applicable · Has a placebo group

Conditions studied: Surgery, Stress, Pain, Children, Post-Traumatic Stress Disorder

In brief

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.

Key facts

Study ID

NCT01738308

Run by

Children's Hospital Medical Center, Cincinnati

People needed

240

Starts

2013-09-01

Expected to finish

2017-06-01

Last updated by the study team

2021-06-24

Who can join

Age: 3 and older, up to 4. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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