Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital Medical Center, Cincinnati | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healing Touch Intervention | Experimental | Healing Touch performed one hour prior to bed. |
|
| Healing Touch Sham | Sham Comparator | Healing Touch Sham provided one hour prior to bed. |
|
| Control, Presence | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Healing Touch | Behavioral |
| ||
| Healing Touch, Sham |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative Cortisol Level | Cortisol level was compared among the 4 study groups. | Labs were drawn immediately pre-op. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michele Gottschlich, PhD | Shriners Hospitals for Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shriners Hospitals for Children | Cincinnati | Ohio | 45231 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Upon verbal agreement, study randomization was assigned and a study consent was mailed to the patient. Arrangements for arrival time the night before surgery for the study procedures were made. After arrival to the unit the guardian reviewed the consent with study staff and upon written consent, study procedures began based on randomization.
The elective surgery patient list was assess for eligible patients. Those scheduled patient meeting inclusion criteria between 5-25 years of age were invited to participate in the study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healing Touch Intervention | Healing Touch performed one hour prior to bed. Healing Touch |
| FG001 | Healing Touch Sham | Healing Touch Sham provided one hour prior to bed. Healing Touch, Sham |
| FG002 | Control, Presence | Control, Presence Intervention in the room one hour prior to bed. Control, Presence |
| FG003 | Control, No Presence | No Presence in the room one hour prior to bed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healing Touch Intervention | Healing Touch performed one hour prior to bed. Healing Touch |
| BG001 | Healing Touch Sham | Healing Touch Sham provided one hour prior to bed. Healing Touch, Sham |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Error | minutes | 8 hours |
|
2 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healing Touch Intervention | Healing Touch performed one hour prior to bed. Healing Touch |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Fowler/Clinical Research Coordinator | Shriners Hosptials for Children | 513-872-6000 | 6249 | lfowler@shrinenet.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2015 | Aug 14, 2017 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D014110 | Touch |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
|
| Control, Presence | Behavioral |
|
| BG002 | Control, Presence | Control, Presence Intervention in the room one hour prior to bed. Control, Presence |
| BG003 | Control, No Presence | No Presence in the room one hour prior to bed. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Number of Participants with Acuity Level 1 | Level 1 is defined as same day surgery and observation (e.g. patients are technically never admitted as inpatient). | Count of Participants | Participants |
|
Control, Presence Intervention in the room one hour prior to bed.
Control, Presence
| OG003 | Control, No Presence | No Presence in the room one hour prior to bed. |
|
|
| Secondary | Preoperative Cortisol Level | Cortisol level was compared among the 4 study groups. | Surgical patients who completed Polysomnography and pre-op study labs. | Posted | Mean | Standard Deviation | mcg/dL | Labs were drawn immediately pre-op. |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Healing Touch Sham | Healing Touch Sham provided one hour prior to bed. Healing Touch, Sham | 0 | 12 | 0 | 12 | 0 | 12 |
| EG002 | Control, Presence | Control, Presence Intervention in the room one hour prior to bed. Control, Presence | 0 | 8 | 0 | 8 | 0 | 8 |
| EG003 | Control, No Presence | No Presence in the room one hour prior to bed. | 0 | 11 | 0 | 11 | 0 | 11 |
Not provided
Not provided
Not provided