The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients (Sleep5)

November 20, 2014 updated by: Lois Claire Cone, R.T. (R) (ARRT), HTCP, M. AmSAT, Shriners Hospitals for Children

The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients: A Prospective Cross Over Trial

Adequate sleep is an important aspect of any healing process, and because it is known that children recovering from burns suffer long term sleep disruptions, the investigators believe that Healing Touch may improve the quality and quantity of sleep in the pediatric burn population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study examines the impact of Healing Touch on the quality and quantity of sleep in pediatric burn survivors. Polysomnography recordings are obtained in order to assess nocturnal sleep in conjunction with Healing Touch; which is done on 1 of 2 nights during Polysomnography. Soft background music is played on both nights.

Healing Touch is performed by one of 2 Healing Touch Certified Practitioners.

Study Type

Interventional

Enrollment (Actual)

29

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, 45229
        • 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 21 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. All pediatric patients (from 5 to 21 years of age) admitted for treatment (following an acute burn injury) to Shriners Hospitals for Children - Cincinnati Burns Hospital will be screened.
  2. Include electrical, flame, scald and chemical burns.
  3. Signed informed consent

Exclusion Criteria:

  1. Patients admitted for treatment unrelated to a burn injury.
  2. Patients admitted for less than 2 nights.
  3. Patients with face and head grafting if they interfere with the lead placements
  4. Neurological disorder

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healing Touch
Other: Healing Touch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of sleep
Time Frame: It takes 1 month for the PSG results to be completed
Comparison of sleep with and without Healing Touch at bedtime. Polysomnography measures whether the patient enters into all the different stages of sleep, particularly Rapid Eye Movement sleep.
It takes 1 month for the PSG results to be completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantity of sleep
Time Frame: It takes 1 month for the polysomnography results to be completed.
Polysomnography measures percentages of sleep stages and the overall duration of the combined stages.
It takes 1 month for the polysomnography results to be completed.

Collaborators and Investigators

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

Sponsor

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

October 1, 2009

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (ESTIMATE)

November 13, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 21, 2014

Last Update Submitted That Met QC Criteria

November 20, 2014

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013 6058 09081008

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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