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Completed

NCT Number: NCT04515381

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

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.

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Key information

Conditions

Stress Disorders of Excessive Somnolence Dyssomnias Fatigue Mental Disorders Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Sleepiness

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mardin Artuklu University

Mardin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic Touch

Other

Therapeutic Touch

Control Group

Other

Making measurements at the beginning of the research and 4 weeks

Sham Therapeutic Touch

Other

Sham Therapeutic Touch

Primary outcomes

  1. Change in Perceived Stress Scale

    Time frame: 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

  2. Change in Epworth Sleepiness Scale

    Time frame: 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.

  3. Change in Pittsburgh Sleep Quality Index

    Time frame: 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"

  4. Change in Visual Analogue Scale

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Registry information

Official study title

Mardin Artuklu University Of Scientific Research Projects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 17, 2020
Registry last updated
Aug 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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