Title: Effect of Therapeutic Touch on Daytime Sleepiness, Stress and Fatigue

Study Overview
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Brief Summary
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Objective: This study was conducted to assess the effect of therapeutic touch on stress, daytime sleepiness, sleep quality and fatigue among the students of nursing and midwifery. Design: Randomized placebo-controlled study.

Detailed Description
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The trial was conducted between April and July 2018. The students who met the inclusion criteria were separated into three groups through randomization method as in therapeutic touch (n=32), placebo (n=32) and control (n=32), and a total of 96 students participated in the study. In this randomized placebo controlled study, the therapeutic touch group were subjected to therapeutic touch for twice a week throughout 4 weeks with each session of 20 minutes. The data was acquired via Student Information Form, Epworth Sleepiness Scale, Pittburgh Sleep Quality Index, Perceived Stress Scale and Visual Analogue Scale for Fatigue.

Official Title
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Mardin Artuklu University Of Scientific Research Projects

Conditions
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Stress, Fatigue, Sleepiness

Intervention / Treatment
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* Other: Therapeutic Touch
* Other: Control group
* Other: Sham Therapeutic Touch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: students who were at and above the age of 18, were the 1st year, 2nd year, 3rd year or 4th year students of nursing or midwifery, did not receive any energy therapy (Reiki, healing touch, therapeutic touch), received a score above 10 from the Epworth sleepiness scale (ESS), did not have any communication problem, and accepted to take part in the study were included in the study. Exclusion Criteria: Students who were getting a psychologic and/or pharmacologic treatment in regard to their sleep, fatigue and stress problems, previously got a psychiatric diagnosis, still had a psychiatric illness, previously or still used anxiety (psychotropic) medicines were excluded from the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic touch group<br>Each student from the Therapeutic touch (TT) group was given TT sessions via Krieger-Kunz method in a total of 8 times in the manner of twice a week for one group (Monday - Wednesday) and another group (Tuesday - Thursday) for a duration of 1 month (4 week). TT application procedure: The procedure was explained to the student, the student person was concentrated, concentrated practitioner for TT application, the student's entire body was evaluated from head to foot with the practitioner's hands at a distance of about 2 inc, hands were moved regularly and rhythmically to prevent imbalances in the energy field, the energy field was re-evaluated from top to bottom and rebalanced if there was a blocked area, finally, the student was left to rest and response to the treatment was observed. The TT sessions of 20 minutes were applied on the students and they were given a short rest at the end of the session | Other: Therapeutic Touch<br>* Therapeutic Touch<br>|
| Placebo Comparator: Placebo group<br>For students in the placebo group, the similar duration (20 minutes) and frequency (2 sessions a week, total of 8 sessions) of TT was applied with hands at a certain distance from the body (approximately 5 cm) and they were moved without a specific order. The application was performed by the other researcher in a separate room to the placebo group. | Other: Sham Therapeutic Touch<br>* Sham Therapeutic Touch<br>|
| Other: Control group<br>There was no attempt being made towards the students within the control group. At the end of the 4th week, all students were asked to repeat measurements | Other: Control group<br>* Making measurements at the beginning of the research and 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Stress Scale | The score of PSS-10 varied from 0 to 40. High score shows the excessiveness of the perceived stress of the individual | Change from baseline and 4 weeks. | 
| Change in Epworth Sleepiness Scale | The scale consists of 8 items and score varies from 0-24. If the total score is between 2-10, it is considered as normal, pathological sleepiness indicator is greater than 10, thirteen and higher values are considered excessive daytime sleepiness. | Change from baseline and 4 weeks. | 
| Change in Pittsburgh Sleep Quality Index | In PSQI analysis, 18 items were scored and there are 7 categories as in subjective sleep quality, delayed sleep, sleep duration, accustomed sleep activity, sleep disorder, use of sleeping pill and daytime dysfunction. Total score varies from 0 to 21. If the total PSQI score is ≤5, it stands for good sleep quality, and if the score is >5, it stands for bad sleep quality | Change from baseline and 4 weeks. | 
| Change in Visual Analogue Scale | The scale of fatigue is a scale of 10 cm that assesses the severity of the fatigue in the last week. The left side of the scale contains the label of I do not feel fatigue, while the right side of the scale contains the label of I Feel Extreme Fatigue and Exhaustion. VASF value is determined through the measurement of the distance between the very left side of the scale and the marked point | Change from baseline and 4 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Therapeutic touch, Daytime sleepiness, Sleep quality, Stress, Fatigue, Nurse-midwifery student