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

Stress Clinical Trial

Official title:

Mardin Artuklu University Of Scientific Research Projects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04515381
• Other study ID #: MAU.SRP.SH.005
• Status: Completed
• Phase: N/A
• Start date: April 20, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: August 2020
• Source: Mardin Artuklu University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 15, 2018
• Est. primary completion date: May 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatigue
• Sleepiness
• Stress

Intervention

Other:
• Therapeutic Touch
Therapeutic Touch
• Control group
Making measurements at the beginning of the research and 4 weeks
• Sham Therapeutic Touch
Sham Therapeutic Touch

Locations

Country	Name	City	State
Turkey	Mardin Artuklu University	Mardin

Sponsors (1)

Lead Sponsor	Collaborator
Mardin Artuklu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.