Status:
COMPLETED
The Effect of Healing Touch on Sleep
Lead Sponsor:
Shriners Hospitals for Children
Collaborating Sponsors:
Children's Hospital Medical Center, Cincinnati
Conditions:
Elective Reconstructive Surgery Population
Eligibility:
All Genders
5-25 years
Phase:
NA
Brief Summary
Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.
Detailed Description
Patients are to randomized into one of 4 treatment groups upon enrollment. Depending on randomization group, the study participant receives the treatment the evening before elective surgery. A polysom...
Eligibility Criteria
Inclusion
- 5-25 years of age, inclusive
- Elective admission for a reconstructive operative procedure
- Planned use of general anesthesia during the elective operative procedure
- Written informed consent, assent and Health Insurance Portability and Accountability Act (HIPAA) release signed by parent or legal guardian
Exclusion
- History of anoxic or suspected brain injury
- History of head injury within the last year
- Pre-existing neurological disorder
- History of Reynaud's syndrome
- Intellectual disability or inability to follow directions
- Face/head phenomena that prevent(s) proper placement of polysomnography(PSG) leads
- Taking medication for diagnosis of cardiomyopathy
Key Trial Info
Start Date :
December 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2017
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01870076
Start Date
December 12 2015
End Date
July 3 2017
Last Update
November 20 2017
Active Locations (1)
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1
Shriners Hospitals for Children
Cincinnati, Ohio, United States, 45231