The Effects of Healing Touch on Post Operative Pediatric Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Children's Hospital Medical Center, Cincinnati
Sponsor:
Collaborators:
American Holistic Nurses Association (AHNA)
Carolyn Stoll Research Fund (Cincinnati Childrens Hospital)
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01738308
First received: November 28, 2012
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Surgery
Stress
Pain
Children
Post-Traumatic Stress Disorder
Procedure: Healing Touch
Procedure: Healing Touch Sham Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Healing Touch on Post-Operative Recovery of Pediatric Tonsillectomies and Adenoidectomies Patients Ages 3 & 4

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • 1. Anxiety [ Time Frame: Day of Surgery (pre and post surgery) & 2 Weeks following Surgery ] [ Designated as safety issue: No ]
    1. 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


Secondary Outcome Measures:
  • 2. Emergence agitation/ emergence delirium [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    PAED scale done every 5 minutes for the first 30 minutes post op Evaluated from videotape by blinded evaluator


Other Outcome Measures:
  • 3. Pain: [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    1. FLACC pain scores evaluated by bedside nurses when first enter PACU & every 15 min for first hour, every 30 minutes 2nd hour, then every hour until discharge
    2. Assessor, blinded observer will evaluate pain on videotape using modified FLACC scale when subject first arrives in PACU at 15min and 30 minutes and at time when subject meets departure criteria
    3. These FLACC scores done by staff nurses and by assessor will be compared.
    4. Frequency and dose of pain medications (Pre-op/ during surgery/ & post-op)
    5. Type and duration of anesthetic agents will be analyzed.

  • 4. Time to wake up [ Time Frame: Day of surgery ] [ Designated as safety issue: No ]
    1. From time patient enters the PACU until awake and alert.
    2. Videotape evaluation by blinded observer

  • 5. Length of stay in the PACU: [ Time Frame: Day of Surgery ] [ Designated as safety issue: No ]
    a. Difference in recorded times-- when subject enters PACU and time subject meets PACU departure criteria as evaluated by PACU nurse. Departure criteria include: Patient is 1. Alert & oriented to place and person and appropriate for age and mental status. 2. Vital signs are stable compared to pre-operative 3. No excessive vomiting as compared to pre-operative 4. Pain is satisfactorily controlled

  • 6. Maladaptive behaviors & ? Has patient needed to be readmitted to hospital for complications [ Time Frame: 2 Weeks Post operativly ] [ Designated as safety issue: No ]
    1. PHBQ done 2 weeks post operatively (When postoperative pain should no longer be a factor).
    2. This will be done by a phone call to subject's house


Estimated Enrollment: 240
Study Start Date: September 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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,

Procedure: 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,

Other Names:
  • Energy Therapy
  • Reiki
Sham Comparator: Sham Healing Touch Treatment
Usual standard of post operative care plus a sham Heal Touch treatment upon entering the post anesthesia care unit
Procedure: Healing Touch Sham Treatment
Other Name: Presence
No Intervention: Control- No treatment done
Usual standard of post operative care with no additional intervention

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Typically developing

  • 3 or 4 years old
  • elective tonsillectomy with or without adenoidectomy
  • ASA I without systemic disease, or 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01738308

Contacts
Contact: Wendy Grace K Rolf, MSN 513-803-0071 wendy.rolf@cchmc.org
Contact: Lois H Bogenschutz, BSN 513-205-07523 lois.bogenschutz@cchmc.org

Locations
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Wendy Grace K Rolf, MSN    513-736-2245 ext pager    wendy.rolf@cchmc.org   
Contact: Lois Bogenshutz, RN    513-803-0788    lois.bogenschutz@cchmc.org   
Principal Investigator: Wendy Grace K Rolf, MSN         
Sub-Investigator: Lois Bogenschutz, BS, RN, CCRP         
Sub-Investigator: Li Lin, MS         
Sub-Investigator: Monica Meier, BSN, CHTP         
Sub-Investigator: Diane Wardell, PhD         
Sub-Investigator: Michelle Zimmer, MD         
Sub-Investigator: Anthony Choi, PhD, MS         
Sub-Investigator: Sian Cotton, PhD         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
American Holistic Nurses Association (AHNA)
Carolyn Stoll Research Fund (Cincinnati Childrens Hospital)
Investigators
Principal Investigator: Wendy Grace K Rolf, MSN CHTP AHN Cincinnati Childrens
  More Information

No publications provided

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01738308     History of Changes
Other Study ID Numbers: 2011-1572
Study First Received: November 28, 2012
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
Healing Touch
Pediatrics
surgery
stress
pain
Pediatric Stress
maladaptive behaviors
energy medicine
emergence delirium
emergence agitation
length of stay
ease of wake up
distress parents
distress pediatric patients
Pediatric Post-Traumatic Stress Disorder

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014