- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04786483
The Effect of Laughter Therapy on Students in the COVID-19 Pandemic
The Effect of Laughter Therapy on Students' Anxiety, Life Satisfaction and Psychological Well-being in the Covid-19 Pandemic
This study was designed as a randomized controlled, pre-test-post-test control group in order to determine the effect of laughter therapy on anxiety, life satisfaction and psychological well-being of nursing students. Laughter therapy was applied to the experimental group for at least 60 minutes, 10 sessions two days a week. For the evaluation, the state-continuity anxiety scale, life satisfaction scale, psychological well-being scale were applied at the pre-application stage (pre-test) and after the laughter therapy sessions (post-test). The following hypotheses were included in this study;
H1: Laughter therapy given during the Covid19 pandemic reduces the anxiety level of intern students.
H2: Laughter therapy given during the Covid19 pandemic affects the life satisfaction of intern students.
H3: During the Covid19 pandemic process, the laughter therapy given to interns affects the relationship between anxiety levels and life satisfaction.
H4: Laughter therapy given to intern students during the Covid19 pandemic process affects psychological well-being.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Zonguldak, Turkey
- Zonguldak Bülent Ecevit University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A student of the Faculty of Health Sciences, Department of Nursing and enrolled in the fall semester,
- Who has not studied laughter yoga before or did not do laughter yoga,
- It will create students who agree to participate in the research.
Exclusion Criteria:
- Being a foreign national,
- Having a situation where laughter yoga is not recommended (having surgery in the abdominal region in the last three months, uncontrolled hypertension, chronic cough, incontinence, acute back pain, acute mental disorders, consumption of antipsychotic drugs, glaucoma, hernia, epilepsy),
- Students with simultaneous participation in any complementary treatment methods will be excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Laughter Therapy group
All students enrolled in the laughter therapy group will receive a total of 10 sessions of laughter therapy, 60 minutes, 2 days a week.
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Laughter therapy will be applied for 60 minutes, 10 sessions, 2 days a week.
The therapy, which starts with the stimulation of the acupuncture points in the palm and acquaintance with hand clapping for an average of 10 minutes, continues with deep breathing and breathing exercises that include diaphragmatic breathing.
The childish games section, which is played to reveal and trigger simulated laughter, is the section where laughter starts as "if" and turns into reality.
The last part is the part where the group makes eye contact for no reason and for no reason, and laughs for at least 3 minutes unconditionally.
In the last part, wish meditation and relaxation sessions are performed.
Other Names:
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No Intervention: Control
No attempt will be made to students in this group.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychological well-being
Time Frame: 4 months
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What are the anxiety levels of the students after the laughter therapy given during the Covid19 pandemic?
State and trait anxiety scales will be used to measure students' anxiety levels before and after laughter therapy.
The scale is a Likert-type scale that separately measures state-continuity anxiety levels with 20 questions.
The scale consists of twenty-item state anxiety and trait anxiety scales, with high scores showing high levels of anxiety, and low scores showing low levels of anxiety.
The total score obtained from both scales varies between 20-80.
Big score indicates high anxiety level, small score indicates low anxiety level.
It is a four-degree scale ranging from "None" to "Totally".
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4 months
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life satisfaction
Time Frame: 4 months
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What is the life satisfaction of the students after the laughter therapy given during the Covid19 pandemic? The life satisfaction levels of the students before and after the laughter therapy will be measured using the 'life satisfaction scale'. The scale consists of five positive statements. The scale, which aims to measure general life satisfaction, is suitable for all ages, from adolescents to adults. The scale has a 7-point Likert type evaluation. Level of participation in scale items "1 = Not at all appropriate", "2 = Not suitable", "3 = Somewhat unsuitable", "4 = Neither suitable nor not appropriate", "5 = Somewhat appropriate", "6 = Not suitable", It is scored as "7 = Very suitable". A minimum of 5 and a maximum of 35 points can be obtained from scale items. A low score on the scale is accepted as an indicator of low life satisfaction. |
4 months
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Psychological Well-being
Time Frame: 4 months
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What are the psychological well-being levels of the students after the laughter therapy given during the Covid19 pandemic? Psychological well-being scale will be used to evaluate students' psychological well-being before and after laughter therapy. Psychological well-being scale consists of eight items. The scale is scored between 1-7. The high score to be obtained from the scale indicates that the person has psychological power. |
4 months
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Collaborators and Investigators
Collaborators
Investigators
- Study Director: Şule Ecevit Alpar, Doctorate, Université
Publications and helpful links
General Publications
- Morishima T, Miyashiro I, Inoue N, Kitasaka M, Akazawa T, Higeno A, Idota A, Sato A, Ohira T, Sakon M, Matsuura N. Effects of laughter therapy on quality of life in patients with cancer: An open-label, randomized controlled trial. PLoS One. 2019 Jun 27;14(6):e0219065. doi: 10.1371/journal.pone.0219065. eCollection 2019.
- Kuru Alici N, Zorba Bahceli P, Emiroglu ON. The preliminary effects of laughter therapy on loneliness and death anxiety among older adults living in nursing homes: A nonrandomised pilot study. Int J Older People Nurs. 2018 Dec;13(4):e12206. doi: 10.1111/opn.12206. Epub 2018 Jul 13.
- Sahu P. Closure of Universities Due to Coronavirus Disease 2019 (COVID-19): Impact on Education and Mental Health of Students and Academic Staff. Cureus. 2020 Apr 4;12(4):e7541. doi: 10.7759/cureus.7541.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021/06
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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