Trial Outcomes & Findings for The Effect of Healing Touch on Sleep (NCT NCT01870076)
NCT ID: NCT01870076
Last Updated: 2017-11-20
Results Overview
Data from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
41 participants
Primary outcome timeframe
8 hours
Results posted on
2017-11-20
Participant Flow
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.
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.
Participant milestones
| Measure |
Healing Touch Intervention
Healing Touch performed one hour prior to bed.
Healing Touch
|
Healing Touch Sham
Healing Touch Sham provided one hour prior to bed.
Healing Touch, Sham
|
Control, Presence
Control, Presence Intervention in the room one hour prior to bed.
Control, Presence
|
Control, No Presence
No Presence in the room one hour prior to bed.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
12
|
8
|
11
|
|
Overall Study
COMPLETED
|
9
|
12
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Healing Touch Intervention
Healing Touch performed one hour prior to bed.
Healing Touch
|
Healing Touch Sham
Healing Touch Sham provided one hour prior to bed.
Healing Touch, Sham
|
Control, Presence
Control, Presence Intervention in the room one hour prior to bed.
Control, Presence
|
Control, No Presence
No Presence in the room one hour prior to bed.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
Baseline Characteristics
The Effect of Healing Touch on Sleep
Baseline characteristics by cohort
| Measure |
Healing Touch Intervention
n=10 Participants
Healing Touch performed one hour prior to bed.
Healing Touch
|
Healing Touch Sham
n=12 Participants
Healing Touch Sham provided one hour prior to bed.
Healing Touch, Sham
|
Control, Presence
n=8 Participants
Control, Presence Intervention in the room one hour prior to bed.
Control, Presence
|
Control, No Presence
n=11 Participants
No Presence in the room one hour prior to bed.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Number of Participants with Acuity Level 1
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 8 hoursData from nocturnal polysomnography, specifically total number of minutes of sleep time, will be compared between the healing touch and non healing touch groups.
Outcome measures
| Measure |
Healing Touch Intervention
n=9 Participants
Healing Touch performed one hour prior to bed.
Healing Touch
|
Healing Touch Sham
n=12 Participants
Healing Touch Sham provided one hour prior to bed.
Healing Touch, Sham
|
Control, Presence
n=7 Participants
Control, Presence Intervention in the room one hour prior to bed.
Control, Presence
|
Control, No Presence
n=11 Participants
No Presence in the room one hour prior to bed.
|
|---|---|---|---|---|
|
Healing Touch Will Improve Total Sleep Time
|
352.9 minutes
Standard Error 17.0
|
368.2 minutes
Standard Error 22.8
|
383.1 minutes
Standard Error 26.4
|
367.2 minutes
Standard Error 19.3
|
SECONDARY outcome
Timeframe: Labs were drawn immediately pre-op.Population: Surgical patients who completed Polysomnography and pre-op study labs.
Cortisol level was compared among the 4 study groups.
Outcome measures
| Measure |
Healing Touch Intervention
n=9 Participants
Healing Touch performed one hour prior to bed.
Healing Touch
|
Healing Touch Sham
n=12 Participants
Healing Touch Sham provided one hour prior to bed.
Healing Touch, Sham
|
Control, Presence
n=7 Participants
Control, Presence Intervention in the room one hour prior to bed.
Control, Presence
|
Control, No Presence
n=11 Participants
No Presence in the room one hour prior to bed.
|
|---|---|---|---|---|
|
Preoperative Cortisol Level
|
6.7 mcg/dL
Standard Deviation 4.2
|
7.1 mcg/dL
Standard Deviation 4.3
|
6.9 mcg/dL
Standard Deviation 3.4
|
17.7 mcg/dL
Standard Deviation 34.1
|
Adverse Events
Healing Touch Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healing Touch Sham
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control, Presence
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control, No Presence
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Laura Fowler/Clinical Research Coordinator
Shriners Hosptials for Children
Phone: 513-872-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place