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

Primary Purpose

Burn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healing Touch
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burn focused on measuring polysomnography, sleep, healing touch, pediatric burn

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shriners Hospitals for Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Healing Touch

Arm Description

Outcomes

Primary Outcome Measures

Quality of sleep
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.

Secondary Outcome Measures

Quantity of sleep
Polysomnography measures percentages of sleep stages and the overall duration of the combined stages.

Full Information

First Posted
September 30, 2013
Last Updated
November 20, 2014
Sponsor
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT01983280
Brief Title
The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients
Acronym
Sleep5
Official Title
The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients: A Prospective Cross Over Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn
Keywords
polysomnography, sleep, healing touch, pediatric burn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healing Touch
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Healing Touch
Primary Outcome Measure Information:
Title
Quality of sleep
Description
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.
Time Frame
It takes 1 month for the PSG results to be completed
Secondary Outcome Measure Information:
Title
Quantity of sleep
Description
Polysomnography measures percentages of sleep stages and the overall duration of the combined stages.
Time Frame
It takes 1 month for the polysomnography results to be completed.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Include electrical, flame, scald and chemical burns. Signed informed consent Exclusion Criteria: Patients admitted for treatment unrelated to a burn injury. Patients admitted for less than 2 nights. Patients with face and head grafting if they interfere with the lead placements Neurological disorder
Facility Information:
Facility Name
Shriners Hospitals for Children
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

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The Effect of Healing Touch on Sleep Patterns of Pediatric Burn Patients

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