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The Effect of Laughter Therapy on Nursing Students (Therapy)

Primary Purpose

Mental Stress, Insomnia, Sleep Disorder

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laughter Therapy
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mental Stress focused on measuring Sleep Quality, Psychological Stress, General Health, Nursing Students, Laughter Therapy

Eligibility Criteria

18 Years - 23 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Volunteering to participate in research Being a 1st or 2nd-year student in the Faculty of Health Sciences, Department of Nursing Not have any health problems that may create a communication barrier Being in a quiet environment to participate in the online study due to the pandemic period Have an internet connection to attend online sessions Exclusion Criteria: Having undergone abdominal surgery in the past three months Having a disability to attend regular sessions

Sites / Locations

  • Muğla Sıtkı Koçman University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laughter Therapy Group

Control Group

Arm Description

A pre-test was administered to all students. In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index and Perceived Stress Scale were applied. Experimental and control groups were formed randomly among the students who filled all the scales. Communication groups were established for the students in both groups without being told which group they belonged to. Considering the hours suitable for the experimental group, 8 sessions of laughter therapy were applied for an average of 45 minutes. At the end of the therapy in the last session, a post-test was administered to all of the students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied.

In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. At the end of the therapy in the last session, a post-test was administered to all students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied.

Outcomes

Primary Outcome Measures

Introductory Information Form
It was prepared by the researchers in line with the literature in order to collect data about the individual characteristics of the participants. Form; family structure, gender, income status, marital status, health status, age, etc. It consists of 13 items (pretest-posttest design was applied).
General Health Questionnaire-28 (GHQ-28)
It was prepared to detect mental health problems. Individuals who score below 5 on the scale are evaluated as "normal", while individuals who score 5 and above are considered as a "risk group" in terms of mental health (pretest-posttest design was applied).
Pittsburgh Sleep Quality Index (PUKI)
"Poor sleep quality" is expressed for individuals who score 5 and above from the scale. The scale consists of 24 items that evaluate sleep quality and disorders by scoring over a one-month period (pretest-posttest design was applied).
Perceived Stress Scale (PSS)
The scale, which was prepared to evaluate the perceived stress level of the individual, consists of 14 items. High scores obtained from the scale indicate that the person has a high perception of stress(pretest-posttest design was applied).

Secondary Outcome Measures

Full Information

First Posted
December 11, 2022
Last Updated
December 27, 2022
Sponsor
Muğla Sıtkı Koçman University
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1. Study Identification

Unique Protocol Identification Number
NCT05681013
Brief Title
The Effect of Laughter Therapy on Nursing Students
Acronym
Therapy
Official Title
The Effect of Laughter Therapy on the General Health Status, Sleep Quality, and Stress Level of Nursing Students
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

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

5. Study Description

Brief Summary
The aim of this study is to determine the effect of laughter therapy on the general health status, sleep quality, and stress level of nursing students.
Detailed Description
H1.1: Students who receive laughter therapy will have lower mean scores in the general health questionnaire than students who do not receive laughter therapy. H1.2: Students who receive laughter therapy will have a lower Pittsburgh sleep quality index score than students who do not receive laughter therapy. H1.3: Students who receive laughter therapy will have a lower mean stress level than students who do not receive laughter therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Stress, Insomnia, Sleep Disorder, Mental Health Disorder
Keywords
Sleep Quality, Psychological Stress, General Health, Nursing Students, Laughter Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laughter Therapy Group
Arm Type
Experimental
Arm Description
A pre-test was administered to all students. In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index and Perceived Stress Scale were applied. Experimental and control groups were formed randomly among the students who filled all the scales. Communication groups were established for the students in both groups without being told which group they belonged to. Considering the hours suitable for the experimental group, 8 sessions of laughter therapy were applied for an average of 45 minutes. At the end of the therapy in the last session, a post-test was administered to all of the students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. At the end of the therapy in the last session, a post-test was administered to all students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied.
Intervention Type
Behavioral
Intervention Name(s)
Laughter Therapy
Intervention Description
The effect of the Laughter Therapy on nursing students
Primary Outcome Measure Information:
Title
Introductory Information Form
Description
It was prepared by the researchers in line with the literature in order to collect data about the individual characteristics of the participants. Form; family structure, gender, income status, marital status, health status, age, etc. It consists of 13 items (pretest-posttest design was applied).
Time Frame
2 minutes
Title
General Health Questionnaire-28 (GHQ-28)
Description
It was prepared to detect mental health problems. Individuals who score below 5 on the scale are evaluated as "normal", while individuals who score 5 and above are considered as a "risk group" in terms of mental health (pretest-posttest design was applied).
Time Frame
5 minutes
Title
Pittsburgh Sleep Quality Index (PUKI)
Description
"Poor sleep quality" is expressed for individuals who score 5 and above from the scale. The scale consists of 24 items that evaluate sleep quality and disorders by scoring over a one-month period (pretest-posttest design was applied).
Time Frame
5 minutes
Title
Perceived Stress Scale (PSS)
Description
The scale, which was prepared to evaluate the perceived stress level of the individual, consists of 14 items. High scores obtained from the scale indicate that the person has a high perception of stress(pretest-posttest design was applied).
Time Frame
3 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteering to participate in research Being a 1st or 2nd-year student in the Faculty of Health Sciences, Department of Nursing Not have any health problems that may create a communication barrier Being in a quiet environment to participate in the online study due to the pandemic period Have an internet connection to attend online sessions Exclusion Criteria: Having undergone abdominal surgery in the past three months Having a disability to attend regular sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Uner, Dr
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muğla Sıtkı Koçman University
City
Mugla
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Laughter Therapy on Nursing Students

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