NCT01983280

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

November 21, 2014

Status Verified

November 1, 2013

Enrollment Period

3.6 years

First QC Date

September 30, 2013

Last Update Submit

November 20, 2014

Conditions

Burn

Keywords

polysomnographysleephealing touchpediatric burn

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Quantity of sleep

    It takes 1 month for the polysomnography results to be completed.

Study Arms (1)

Healing Touch

EXPERIMENTAL
Other: Healing Touch

Interventions

Healing TouchOTHER
Healing Touch

Eligibility Criteria

Age5 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shriners Hospitals for Children

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Touch

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

SensationNervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Manager, Radiology

Study Record Dates

First Submitted

September 30, 2013

First Posted

November 13, 2013

Study Start

October 1, 2009

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 21, 2014

Record last verified: 2013-11

Locations

US(1)