Effectiveness of Healing Touch on Sleep, Pain, Anxiety, Anesthesia Emergence, Satisfaction and Cost of Care in Surgical
| Registry | NCT01870076, acronym Sleep7 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: quadruple, treatment |
| Enrollment | 41 (Actual) |
| Sponsor | Shriners Hospitals for Children (Other); collaborators: Children's Hospital Medical Center, Cincinnati |
| Conditions | Elective Reconstructive Surgery Population |
| Interventions | Healing Touch, Healing Touch, Sham, Control, Presence (Behavioral) |
| Dates | start 2015-12-12, primary completion 2017-05-15, completion 2017-07-03, first posted 2013-06-05, last updated 2017-11-20 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Elective Reconstructive Surgery Population All trials of Healing Touch All trials of Healing Touch, Sham
Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Healing Touch Intervention | Experimental | Behavioral: Healing Touch | Healing Touch performed one hour prior to bed. |
| Healing Touch Sham | Sham comparator | Behavioral: Healing Touch, Sham | Healing Touch Sham provided one hour prior to bed. |
| Control, Presence | Active comparator | Behavioral: Control, Presence | Control, Presence Intervention in the room one hour prior to bed. |
| Control, No Presence | No intervention | No Presence in the room one hour prior to bed. |
Sex: All, ages: 5 Years to 25 Years, 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
| Milestone | Healing Touch Intervention | Healing Touch Sham | Control, Presence | Control, No Presence |
|---|---|---|---|---|
| Started | 10 | 12 | 8 | 11 |
| Completed | 9 | 12 | 7 | 11 |
| Not completed | 1 | 0 | 1 | 0 |
Time frame: 2 years
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Healing Touch Intervention | 0/10 (0.0%) | 0/10 (0.0%) | 0/10 (0.0%) |
| Healing Touch Sham | 0/12 (0.0%) | 0/12 (0.0%) | 0/12 (0.0%) |
| Control, Presence | 0/8 (0.0%) | 0/8 (0.0%) | 0/8 (0.0%) |
| Control, No Presence | 0/11 (0.0%) | 0/11 (0.0%) | 0/11 (0.0%) |
| Facility | City | Country | Status |
|---|---|---|---|
| Shriners Hospitals for Children | Cincinnati, Ohio | United States |