Clinical trial NCT04786483: The Effect of Laughter Therapy on Students in the COVID-19 Pandemic
Official title: The Effect of Laughter Therapy on Students' Anxiety, Life Satisfaction and Psychological Well-being in the Covid-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laughter Yoga
Anxiety
Life Satisfaction
Psychological Well-being
COVID-19
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
Collaborators: name: Prof. Dr. Şule Ecevit Alpar
First posted: 2021-03-08
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: Today, all countries are struggling with COVID-19, which typically presents with mild symptoms but causes serious mortality in the world population. In addition to the routine changes due to the pandemic, face-to-face education has been switched to online education. The integration of online education and more technology into the curriculum than ever before has increased students' anxiety towards learning. It was also found to cause high levels of anxiety and stress, characterized by feelings of risk, insecurity, and unhappiness. Studies show that high levels of anxiety negatively affect students' adaptation to daily life and their life satisfaction levels. In recent years, non-pharmacological techniques have been widely used in reducing anxiety and stress. One of them is laughter therapy. Laughter therapy reduces feelings of negative stress, anxiety, and depression by increasing the body's readiness to deal with different types of problems. The aim of this study is to examine the effects of online laughter therapy on anxiety, life satisfaction and psychological well-being levels of nursing students, who have switched to online education during the pandemic process.

Eligibility criteria: 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.

Primary outcomes:
measure: psychological well-being
timeFrame: 4 months
measure: life satisfaction
timeFrame: 4 months
measure: Psychological Well-being
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Zonguldak Bülent Ecevit University
Study officials:
affiliation: Üniversite
name: Şule Ecevit Alpar, Doctorate
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.