The Effect of Healing Touch on Sleep
Sleep7
Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical
1 other identifier
interventional
41
1 country
1
Brief Summary
Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2013
CompletedFirst Posted
Study publicly available on registry
June 5, 2013
CompletedStudy Start
First participant enrolled
December 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2017
CompletedResults Posted
Study results publicly available
November 20, 2017
CompletedNovember 20, 2017
October 1, 2017
1.4 years
May 28, 2013
July 15, 2017
October 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Healing Touch Will Improve Total Sleep Time
Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.
8 hours
Secondary Outcomes (1)
Preoperative Cortisol Level
Labs were drawn immediately pre-op.
Study Arms (4)
Healing Touch Intervention
EXPERIMENTALHealing Touch performed one hour prior to bed.
Healing Touch Sham
SHAM COMPARATORHealing Touch Sham provided one hour prior to bed.
Control, Presence
ACTIVE COMPARATORControl, Presence Intervention in the room one hour prior to bed.
Control, No Presence
NO INTERVENTIONNo Presence in the room one hour prior to bed.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shriners Hospitals for Children
Cincinnati, Ohio, 45231, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Laura Fowler/Clinical Research Coordinator
- Organization
- Shriners Hosptials for Children
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Gottschlich, PhD
Shriners Hospitals for Children
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Scientist
Study Record Dates
First Submitted
May 28, 2013
First Posted
June 5, 2013
Study Start
December 12, 2015
Primary Completion
May 15, 2017
Study Completion
July 3, 2017
Last Updated
November 20, 2017
Results First Posted
November 20, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share