Brief Summary

In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing touch as adjunct therapies to the standard of care, will improve analgesic use for post operative pain. In this pilot study the investigators will randomize 30 adolescents undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of Care, and a control group (Pain Management Standard of Care only).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Aug 2014

Typical duration for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

August 1, 2014

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2015

Completed

6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2017

Completed

7.4 years until next milestone

Results Posted

Study results publicly available

August 27, 2024

Completed

Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

2.7 years

First QC Date

April 1, 2015

Results QC Date

November 15, 2019

Last Update Submit

August 23, 2024

Conditions

Idiopathic Scoliosis

Keywords

Complementary therapiesHypnosisHealing Touch

Outcome Measures

Primary Outcomes (1)

Postoperative Pain (Total Opioid Use)
Total Opioid use will be measured in mg/kg/hour daily until discharge, and at postoperative follow-up visit. Postoperative time in PACU starts on admission to PACU until discharged to general nursing care floors. Postoperative Day #0 (POD #0) start on the day of surgery from the time the patient is discharged from the PACU to 7:00 AM the following morning. POD #1 is from 07:00 the day after surgery to the following morning (24 hour period) at 07:00. POD #2, POD #3 are the following 24 hour periods until time of discharge. The first outpatient postoperative appointment was four weeks after surgery.
up to postoperative day 4

Secondary Outcomes (3)

Pain Score
up to postoperative day 4
Cortisol Level
up to 4-week postoperatively
Child Pain Anxiety Symptoms Scale (CPASS)
up to 4 weeks postoperatively

Study Arms (3)

Hypnosis Group

ACTIVE COMPARATOR

Hypnosis Group: ten participants will receive Hypnosis therapy in addition to the standard postoperative pain management protocol

Other: Hypnosis Therapy

Healing Touch Group

ACTIVE COMPARATOR

Healing Touch Group: ten participants will receive Healing Touch therapy in addition to the standard postoperative pain management protocol

Other: Healing Touch Therapy

Control Group

NO INTERVENTION

Control Group: ten participants will receive standard postoperative pain management protocol

Interventions

Hypnosis TherapyOTHER

A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness

Hypnosis Group

Healing Touch TherapyOTHER

Healing Touch An energery based therapy that uses light body or above body touch to help balance the energy field and energy centers of the body to restore harmony within the body for greater healing.

Healing Touch Group

Eligibility Criteria

Age12 Years - 17 Years

Sexfemale

Healthy VolunteersYes

Age GroupsChild (0-17)

You may qualify if:

Females, ages 12 - 17
Diagnosis of idiopathic scoliosis

You may not qualify if:

Patients with chronic or severe disease conditions requiring spinal fusion surgery.
Children with profound mental disabilities or developmental delay not allowing them to voluntarily assent to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Nemours Children's Cliniclead
Healing Touch Worldwide Foundationcollaborator

Study Sites (1)

Nemours / A I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Related Publications (7)

Kemper KJ, Vohra S, Walls R; Task Force on Complementary and Alternative Medicine; Provisional Section on Complementary, Holistic, and Integrative Medicine. American Academy of Pediatrics. The use of complementary and alternative medicine in pediatrics. Pediatrics. 2008 Dec;122(6):1374-86. doi: 10.1542/peds.2008-2173.
PMID: 19047261BACKGROUND
Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Report. 2008 Dec 10;(12):1-23.
PMID: 19361005BACKGROUND
Sanders H, Davis MF, Duncan B, Meaney FJ, Haynes J, Barton LL. Use of complementary and alternative medical therapies among children with special health care needs in southern Arizona. Pediatrics. 2003 Mar;111(3):584-7. doi: 10.1542/peds.111.3.584.
PMID: 12612240BACKGROUND
Post-White J, Fitzgerald M, Hageness S, Sencer SF. Complementary and alternative medicine use in children with cancer and general and specialty pediatrics. J Pediatr Oncol Nurs. 2009 Jan-Feb;26(1):7-15. doi: 10.1177/1043454208323914. Epub 2008 Oct 20.
PMID: 18936292BACKGROUND
Hagen LE, Schneider R, Stephens D, Modrusan D, Feldman BM. Use of complementary and alternative medicine by pediatric rheumatology patients. Arthritis Rheum. 2003 Feb 15;49(1):3-6. doi: 10.1002/art.10931.
PMID: 12579587BACKGROUND
Lew MW, Kravits K, Garberoglio C, Williams AC. Use of preoperative hypnosis to reduce postoperative pain and anesthesia-related side effects. Int J Clin Exp Hypn. 2011 Oct-Dec;59(4):406-23. doi: 10.1080/00207144.2011.594737.
PMID: 21867377BACKGROUND
Accardi MC, Milling LS. The effectiveness of hypnosis for reducing procedure-related pain in children and adolescents: a comprehensive methodological review. J Behav Med. 2009 Aug;32(4):328-39. doi: 10.1007/s10865-009-9207-6. Epub 2009 Mar 3.
PMID: 19255840BACKGROUND

Results Point of Contact

Title: Karen Sacks, MSN PNP
Organization: Nemours/A I duPont Hospital for Children

Study Officials

Karen Sacks, MSN, PNP
Nemours / A I duPont Hospital for Children
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: MSN, PNP

Study Record Dates

First Submitted

April 1, 2015

First Posted

April 7, 2015

Study Start

August 1, 2014

Primary Completion

March 27, 2017

Study Completion

March 27, 2017

Last Updated

August 27, 2024

Results First Posted

August 27, 2024

Record last verified: 2024-08

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (3)

Hypnosis Group

Healing Touch Group

Control Group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (7)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations