The Effect of Healing Touch on Sleep

Study Overview
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Brief Summary
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Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.

Detailed Description
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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 polysomnographic sleep study is then completed. Plan is to review the effect of the treatment group on sleep quantity and sleep quality.

Official Title
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Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical

Conditions
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Elective Reconstructive Surgery Population

Intervention / Treatment
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* Behavioral: Healing Touch
* Behavioral: Healing Touch, Sham
* Behavioral: Control, Presence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healing Touch Intervention<br>Healing Touch performed one hour prior to bed. | Behavioral: Healing Touch<br> <br> |
| Sham Comparator: Healing Touch Sham<br>Healing Touch Sham provided one hour prior to bed. | Behavioral: Healing Touch, Sham<br> <br> |
| Active Comparator: Control, Presence<br>Control, Presence Intervention in the room one hour prior to bed. | Behavioral: Control, Presence<br> <br> |
| No Intervention: Control, No Presence<br>No Presence in the room one hour prior to bed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative Cortisol Level | Cortisol level was compared among the 4 study groups. | Labs were drawn immediately pre-op. |