The Effect of Healing Touch on Sleep (Sleep7)

Shriners Hospitals for Children

Status: Completed

Conditions: Elective Reconstructive Surgery Population

Treatments: Behavioral: Control, Presence; Behavioral: Healing Touch; Behavioral: Healing Touch, Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT01870076

2015-1253

Details and patient eligibility

About

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

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

Enrollment: 41 patients

Sex: All

Ages: 5 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 5-25 years of age, inclusive
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

1. History of anoxic or suspected brain injury
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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41 participants in 4 patient groups

Healing Touch Intervention

Experimental group

Description:

Healing Touch performed one hour prior to bed.

Treatment:

Behavioral: Healing Touch

Healing Touch Sham

Sham Comparator group

Description:

Healing Touch Sham provided one hour prior to bed.

Treatment:

Behavioral: Healing Touch, Sham

Control, Presence

Active Comparator group

Description:

Control, Presence Intervention in the room one hour prior to bed.

Treatment:

Behavioral: Control, Presence

Control, No Presence

No Intervention group

Description:

No Presence in the room one hour prior to bed.