The Effect of Healing Touch on Sleep (Sleep7)

October 12, 2017 updated by: Michele Gottschlich, Shriners Hospitals for Children

Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • Shriners Hospitals for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healing Touch Intervention
Healing Touch performed one hour prior to bed.
Behavioral: Healing Touch
Sham Comparator: Healing Touch Sham
Healing Touch Sham provided one hour prior to bed.
Behavioral: Healing Touch, Sham
Active Comparator: Control, Presence
Control, Presence Intervention in the room one hour prior to bed.
Behavioral: Control, Presence
No Intervention: Control, No Presence
No Presence in the room one hour prior to bed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing Touch Will Improve Total Sleep Time
Time Frame: 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.
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Cortisol Level
Time Frame: Labs were drawn immediately pre-op.
Cortisol level was compared among the 4 study groups.
Labs were drawn immediately pre-op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shriners Hospitals for Children

Collaborators

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Michele Gottschlich, PhD, Shriners Hospitals for Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2015

Primary Completion (Actual)

May 15, 2017

Study Completion (Actual)

July 3, 2017

Study Registration Dates

First Submitted

May 28, 2013

First Submitted That Met QC Criteria

June 2, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-1253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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