The Effect of Healing Touch on Sleep Patterns of Pediatri... | NCT01983280

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

NCT01983280

Sponsor

Shriners Hospitals for Children

Status

Completed

Last Update Posted

Nov 21, 2014Estimated

Enrollment

29Actual

Phase

Not Applicable

Conditions

Burn

Interventions

Healing Touch

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2009

Primary Completion Date

May 2013Actual

Completion Date

May 2013Actual

First Submitted Date

Sep 30, 2013

First Submission Date that Met QC Criteria

Nov 6, 2013

First Posted Date

Nov 13, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2014

Last Update Posted Date

Nov 21, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lois Claire Cone, R.T. (R) (ARRT), HTCP, M. AmSAT, Manager, Radiology, Shriners Hospitals for ChildrenPrincipal Investigator

Lead Sponsor

Shriners Hospitals for ChildrenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

29Actual

Label	Type	Description	Intervention Names
Healing Touch	Experimental		Other: Healing Touch

Name	Type	Description	Arm Group Labels	Other Names
Healing Touch	Other		Healing Touch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shriners Hospitals for Children		Cincinnati	Ohio	45229	United States

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D014110	Touch

Ancestor Terms

ID	Term
D012677	Sensation
D009424	Nervous System Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided