The Effect of Healing Touch on Sleep

Not Applicable

Completed

• Conditions: Elective Reconstructive Surgery Population
• Interventions: Behavioral: Healing Touch; Behavioral: Healing Touch, Sham; Behavioral: Control, Presence

• Registration Number: NCT01870076
• Lead Sponsor: Shriners Hospitals for Children

Brief Summary

Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.

Detailed Description

Patients are to randomized into one of 4 treatment groups upon enrollment. Depending on randomization group, the study participant receives the treatment the evening before elective surgery. A polysomnographic sleep study is then completed. Plan is to review the effect of the treatment group on sleep quantity and sleep quality.

Study Timeline

• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-06-02
• Study First Posted: 2013-06-05
• Study Start: 2015-12-12
• Primary Completion: 2017-05-15
• Study Completion: 2017-07-03
• Results First Submitted: 2017-07-15
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-12
• Last Update Submitted: 2017-10-12
• Results First Posted: 2017-11-20
• Last Update Posted: 2017-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. 5-25 years of age, inclusive
2. Elective admission for a reconstructive operative procedure
3. Planned use of general anesthesia during the elective operative procedure
4. Written informed consent, assent and Health Insurance Portability and Accountability Act (HIPAA) release signed by parent or legal guardian

Exclusion Criteria

1. History of anoxic or suspected brain injury
2. History of head injury within the last year
3. Pre-existing neurological disorder
4. History of Reynaud's syndrome
5. Intellectual disability or inability to follow directions
6. Face/head phenomena that prevent(s) proper placement of polysomnography(PSG) leads
7. Taking medication for diagnosis of cardiomyopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healing Touch Intervention	Healing Touch	Healing Touch performed one hour prior to bed.
Healing Touch Sham	Healing Touch, Sham	Healing Touch Sham provided one hour prior to bed.
Control, Presence	Control, Presence	Control, Presence Intervention in the room one hour prior to bed.

Primary Outcome Measures

Name	Time	Method
Healing Touch Will Improve Total Sleep Time	8 hours	Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.

Secondary Outcome Measures

Name	Time	Method
Preoperative Cortisol Level	Labs were drawn immediately pre-op.	Cortisol level was compared among the 4 study groups.

Trial Locations

Locations (1)

Shriners Hospitals for Children; 🇺🇸 Cincinnati, Ohio, United States