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

Not Applicable

Completed

• Conditions: Fatigue; Stress; Sleepiness

• Registration Number: NCT04515381
• Lead Sponsor: Mardin Artuklu University

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-04-20
• Primary Completion: 2018-05-01
• Study Completion: 2018-06-15
• Status Verified: 2020-08
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-14
• Last Update Submitted: 2020-08-14
• Study First Posted: 2020-08-17
• Last Update Posted: 2020-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Perceived Stress Scale	Change from baseline and 4 weeks.	The score of PSS-10 varied from 0 to 40. High score shows the excessiveness of the perceived stress of the individual
Change in Visual Analogue Scale	Change from baseline and 4 weeks.	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 in Epworth Sleepiness Scale	Change from baseline and 4 weeks.	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 in Pittsburgh Sleep Quality Index	Change from baseline and 4 weeks.	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"

Trial Locations

Locations (1)

Mardin Artuklu University; 🇹🇷 Mardin, Turkey