Trial Outcomes & Findings for The Effect of Therapeutic Touch on Sleep and Anxiety (NCT NCT05363787)
NCT ID: NCT05363787
Last Updated: 2026-04-13
Results Overview
The Visual Analogue Scale - Anxiety Subtest (VAS-Anxiety) was used to measure anxiety levels. Scores ranged from 0 to 100, where 0 represents no anxiety and 100 represents the highest possible anxiety. Higher scores indicate a worse outcome. Patients marked their anxiety level on the scale, and this score was recorded as the outcome measure.
COMPLETED
NA
68 participants
pretest (Measurements taken during the initial consultation)
2026-04-13
Participant Flow
The population of the study consisted of 368 patients aged 65-85 years who applied to the clinic within one year. The sample size of the study was calculated by G-power analysis. The sample consisted of 68 patients, 34 in the experimental group and 34 in the control group.
Inclusion Criteria; Between 65 and 85 years of age according to the WHO classification of 1998, The patient was hospitalised in the orthopaedics and traumatology service for at least seven days, The patient is able to communicate. Exclusion Criteria; The presence of a hearing impairment, Intubation, In the acute pain period
Participant milestones
| Measure |
Experimental Group
Therapeutic touch was administered to this group.
|
Control Group
No intervention was administered to this group.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Therapeutic Touch on Sleep and Anxiety
Baseline characteristics by cohort
| Measure |
Experimental Group
n=34 Participants
Therapeutic touch was administered to this group.
|
Control Group
n=34 Participants
No intervention was administered to this group.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.74 years
STANDARD_DEVIATION 6.50 • n=193 Participants
|
70.50 years
STANDARD_DEVIATION 4.84 • n=193 Participants
|
71.12 years
STANDARD_DEVIATION 5.67 • n=386 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=193 Participants
|
22 Participants
n=193 Participants
|
47 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=193 Participants
|
12 Participants
n=193 Participants
|
21 Participants
n=386 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=193 Participants
|
34 Participants
n=193 Participants
|
68 Participants
n=386 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Total Count of Participants
|
34 Participants
n=193 Participants
|
34 Participants
n=193 Participants
|
68 Participants
n=386 Participants
|
PRIMARY outcome
Timeframe: pretest (Measurements taken during the initial consultation)Population: The analysis included only participants who completed the intervention according to the study protocol.
The Visual Analogue Scale - Anxiety Subtest (VAS-Anxiety) was used to measure anxiety levels. Scores ranged from 0 to 100, where 0 represents no anxiety and 100 represents the highest possible anxiety. Higher scores indicate a worse outcome. Patients marked their anxiety level on the scale, and this score was recorded as the outcome measure.
Outcome measures
| Measure |
Experimental Group
n=34 Participants
Therapeutic touch was administered to this group.
|
Control Group
n=34 Participants
No intervention was administered to this group.
|
|---|---|---|
|
Visual Analogue Scale
|
60.6 score on a scale
Standard Deviation 20.4
|
54.7 score on a scale
Standard Deviation 19.1
|
PRIMARY outcome
Timeframe: pretest (Measurements taken during the initial consultation)Population: The analysis included only participants who completed the intervention according to the study protocol
In this measurement, the sleep duration was recorded as subjective data by the researcher. (Calculated based on the intended bedtime and wake-up time)
Outcome measures
| Measure |
Experimental Group
n=34 Participants
Therapeutic touch was administered to this group.
|
Control Group
n=34 Participants
No intervention was administered to this group.
|
|---|---|---|
|
Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration)
|
6.71 hours
Standard Deviation 1.17
|
7.21 hours
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: posttest (three weeks after the pre-test)Population: The analysis included only participants who completed the intervention according to the study protocol.
The Visual Analogue Scale - Anxiety Subtest (VAS-Anxiety) was used to measure anxiety levels. Scores ranged from 0 to 100, where 0 represents no anxiety and 100 represents the highest possible anxiety. Higher scores indicate a worse outcome. Patients marked their anxiety level on the scale, and this score was recorded as the outcome measure.
Outcome measures
| Measure |
Experimental Group
n=34 Participants
Therapeutic touch was administered to this group.
|
Control Group
n=34 Participants
No intervention was administered to this group.
|
|---|---|---|
|
Visual Analogue Scale
|
45.9 score on a scale
Standard Deviation 13.1
|
62.9 score on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: posttest (three weeks after the pre-test)In this measurement, the sleep duration was recorded as subjective data by the researcher. (Calculated based on the intended bedtime and wake-up time)
Outcome measures
| Measure |
Experimental Group
n=34 Participants
Therapeutic touch was administered to this group.
|
Control Group
n=34 Participants
No intervention was administered to this group.
|
|---|---|---|
|
Comparison of Sleep Duration and Sleep Onset Difficulties by Group at Measurement Times (Sleep Duration)
|
6.50 hours
Standard Deviation 1.24
|
7.26 hours
Standard Deviation 1.73
|
Adverse Events
Experimental Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place