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

Burn Clinical Trial

— Sleep5  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983280
• Other study ID #: 2013 6058 09081008
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: November 20, 2014
• Start date: October 2009
• Est. completion date: May 2013

Study information

• Verified date: November 2013
• Source: Shriners Hospitals for Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 21 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

Other:
• Healing Touch

Locations

Country	Name	City	State
United States	Shriners Hospitals for Children	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	It takes 1 month for the PSG results to be completed	No
Secondary	Quantity of sleep	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.	No