Elective Reconstructive Surgery Population
Conditions
Brief summary
Healing Touch improves measures of sleep the night prior to surgery, thus improving surgery-related morbidity.
Detailed 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.
Interventions
Sponsors
Children's Hospital Medical Center, Cincinnati
Shriners Hospitals for Children
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 25 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Healing Touch Will Improve Total Sleep Time | 8 hours | Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Preoperative Cortisol Level | Labs were drawn immediately pre-op. | Cortisol level was compared among the 4 study groups. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Healing Touch Intervention Healing Touch performed one hour prior to bed.
Healing Touch | 10 |
| Healing Touch Sham Healing Touch Sham provided one hour prior to bed.
Healing Touch, Sham | 12 |
| Control, Presence Control, Presence Intervention in the room one hour prior to bed.
Control, Presence | 8 |
| Control, No Presence No Presence in the room one hour prior to bed. | 11 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Healing Touch Intervention | Healing Touch Sham | Control, Presence | Control, No Presence | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 12 Participants | 6 Participants | 8 Participants | 35 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 6 Participants |
| Number of Participants with Acuity Level 1 | 3 Participants | 7 Participants | 5 Participants | 4 Participants | 19 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 3 Participants | 1 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 9 Participants | 4 Participants | 7 Participants | 25 Participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 6 Participants | 4 Participants | 23 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 2 Participants | 7 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 12 | 0 / 8 | 0 / 11 |
| other Total, other adverse events | 0 / 10 | 0 / 12 | 0 / 8 | 0 / 11 |
| serious Total, serious adverse events | 0 / 10 | 0 / 12 | 0 / 8 | 0 / 11 |
Outcome results
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.
Time frame: 8 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healing Touch Intervention | Healing Touch Will Improve Total Sleep Time | 352.9 minutes | Standard Error 17 |
| Healing Touch Sham | Healing Touch Will Improve Total Sleep Time | 368.2 minutes | Standard Error 22.8 |
| Control, Presence | Healing Touch Will Improve Total Sleep Time | 383.1 minutes | Standard Error 26.4 |
| Control, No Presence | Healing Touch Will Improve Total Sleep Time | 367.2 minutes | Standard Error 19.3 |
Secondary
Preoperative Cortisol Level
Cortisol level was compared among the 4 study groups.
Time frame: Labs were drawn immediately pre-op.
Population: Surgical patients who completed Polysomnography and pre-op study labs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healing Touch Intervention | Preoperative Cortisol Level | 6.7 mcg/dL | Standard Deviation 4.2 |
| Healing Touch Sham | Preoperative Cortisol Level | 7.1 mcg/dL | Standard Deviation 4.3 |
| Control, Presence | Preoperative Cortisol Level | 6.9 mcg/dL | Standard Deviation 3.4 |
| Control, No Presence | Preoperative Cortisol Level | 17.7 mcg/dL | Standard Deviation 34.1 |