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The Effect of Laughter Therapy on Students in the COVID-19 Pandemic

Primary Purpose

Laughter Yoga, Anxiety, Life Satisfaction

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Laughter Theraphy
Sponsored by
Zonguldak Bulent Ecevit University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Laughter Yoga

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Zonguldak Bülent Ecevit University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Laughter Therapy group

Control

Arm Description

All students enrolled in the laughter therapy group will receive a total of 10 sessions of laughter therapy, 60 minutes, 2 days a week.

No attempt will be made to students in this group.

Outcomes

Primary Outcome Measures

psychological well-being
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".
life satisfaction
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.
Psychological Well-being
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.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2021
Last Updated
March 5, 2021
Sponsor
Zonguldak Bulent Ecevit University
Collaborators
Prof. Dr. Şule Ecevit Alpar
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1. Study Identification

Unique Protocol Identification Number
NCT04786483
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
May 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zonguldak Bulent Ecevit University
Collaborators
Prof. Dr. Şule Ecevit Alpar

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laughter Yoga, Anxiety, Life Satisfaction, Psychological Well-being, COVID-19

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laughter Therapy group
Arm Type
Experimental
Arm Description
All students enrolled in the laughter therapy group will receive a total of 10 sessions of laughter therapy, 60 minutes, 2 days a week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No attempt will be made to students in this group.
Intervention Type
Other
Intervention Name(s)
Laughter Theraphy
Other Intervention Name(s)
Alternative
Intervention Description
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.
Primary Outcome Measure Information:
Title
psychological well-being
Description
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".
Time Frame
4 months
Title
life satisfaction
Description
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.
Time Frame
4 months
Title
Psychological Well-being
Description
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.
Time Frame
4 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şule Ecevit Alpar, Doctorate
Organizational Affiliation
Üniversite
Official's Role
Study Director
Facility Information:
Facility Name
Zonguldak Bülent Ecevit University
City
Zonguldak
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31247017
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.
Results Reference
background
PubMed Identifier
30004172
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.
Results Reference
background
PubMed Identifier
32377489
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.
Results Reference
result

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The Effect of Laughter Therapy on Students in the COVID-19 Pandemic

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