Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2015-12-12
2017-07-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Healing Touch Intervention
Healing Touch performed one hour prior to bed.
Healing Touch
Healing Touch Sham
Healing Touch Sham provided one hour prior to bed.
Healing Touch, Sham
Control, Presence
Control, Presence Intervention in the room one hour prior to bed.
Control, Presence
Control, No Presence
No Presence in the room one hour prior to bed.
No interventions assigned to this group
Interventions
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Healing Touch
Healing Touch, Sham
Control, Presence
Eligibility Criteria
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Inclusion Criteria
2. Elective admission for a reconstructive operative procedure
3. Planned use of general anesthesia during the elective operative procedure
4. Written informed consent, assent and Health Insurance Portability and Accountability Act (HIPAA) release signed by parent or legal guardian
Exclusion Criteria
2. History of head injury within the last year
3. Pre-existing neurological disorder
4. History of Reynaud's syndrome
5. Intellectual disability or inability to follow directions
6. Face/head phenomena that prevent(s) proper placement of polysomnography(PSG) leads
7. Taking medication for diagnosis of cardiomyopathy
5 Years
25 Years
ALL
Yes
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Shriners Hospitals for Children
OTHER
Responsible Party
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Michele Gottschlich
Research Scientist
Principal Investigators
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Michele Gottschlich, PhD
Role: PRINCIPAL_INVESTIGATOR
Shriners Hospitals for Children
Locations
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Shriners Hospitals for Children
Cincinnati, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-1253
Identifier Type: -
Identifier Source: org_study_id