- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05681013
The Effect of Laughter Therapy on Nursing Students (Therapy)
The Effect of Laughter Therapy on the General Health Status, Sleep Quality, and Stress Level of Nursing Students
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mugla, Turkey
- Muğla Sıtkı Koçman University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Laughter Therapy Group
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.
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The effect of the Laughter Therapy on nursing students
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No Intervention: Control Group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Introductory Information Form
Time Frame: 2 minutes
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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).
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2 minutes
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General Health Questionnaire-28 (GHQ-28)
Time Frame: 5 minutes
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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).
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5 minutes
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Pittsburgh Sleep Quality Index (PUKI)
Time Frame: 5 minutes
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"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).
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5 minutes
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Perceived Stress Scale (PSS)
Time Frame: 3 minutes
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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).
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3 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Elif Uner, Dr, Muğla Sıtkı Koçman University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 739904
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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