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

Primary Purpose

Stress, Fatigue, Sleepiness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Touch
Control group
Sham Therapeutic Touch
Sponsored by
Mardin Artuklu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stress focused on measuring Therapeutic touch, Daytime sleepiness, Sleep quality, Stress, Fatigue, Nurse-midwifery student

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mardin Artuklu University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Therapeutic touch group

Placebo group

Control group

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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 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 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 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

Secondary Outcome Measures

Full Information

First Posted
August 6, 2020
Last Updated
August 14, 2020
Sponsor
Mardin Artuklu University
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1. Study Identification

Unique Protocol Identification Number
NCT04515381
Brief Title
Title: Effect of Therapeutic Touch on Daytime Sleepiness, Stress and Fatigue
Official Title
Mardin Artuklu University Of Scientific Research Projects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 20, 2018 (Actual)
Primary Completion Date
May 1, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mardin Artuklu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Fatigue, Sleepiness
Keywords
Therapeutic touch, Daytime sleepiness, Sleep quality, Stress, Fatigue, Nurse-midwifery student

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic touch group
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Therapeutic Touch
Intervention Description
Therapeutic Touch
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
Making measurements at the beginning of the research and 4 weeks
Intervention Type
Other
Intervention Name(s)
Sham Therapeutic Touch
Intervention Description
Sham Therapeutic Touch
Primary Outcome Measure Information:
Title
Change in Perceived Stress Scale
Description
The score of PSS-10 varied from 0 to 40. High score shows the excessiveness of the perceived stress of the individual
Time Frame
Change from baseline and 4 weeks.
Title
Change in Epworth Sleepiness Scale
Description
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.
Time Frame
Change from baseline and 4 weeks.
Title
Change in Pittsburgh Sleep Quality Index
Description
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"
Time Frame
Change from baseline and 4 weeks.
Title
Change in Visual Analogue Scale
Description
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
Time Frame
Change from baseline and 4 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mardin Artuklu University
City
Mardin
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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