Laughter YogaNCT04786483
The Effect of Laughter Therapy on Students in the COVID-19 Pandemic
A study testing Laughter Theraphy in people with Laughter Yoga and Anxiety, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga, Anxiety, Life Satisfaction
- What is being tested?
- Laughter Theraphy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2020to 10 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Laughter Yoga, Anxiety, Life Satisfaction, Psychological Well-being, COVID-19
- Being tested
- Laughter Theraphy
- Medical subject headings
- Anxiety Disorders, Personal Satisfaction, Psychological Well-Being, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter TheraphyOther
Also called Alternative
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.
| Study group | Role | What they receive |
|---|---|---|
| Laughter Therapy group | Experimental | All students enrolled in the laughter therapy group will receive a total of 10 sessions of laughter therapy, 60 minutes, 2 days a week. Receives: Other: Laughter Theraphy |
| Control | No intervention | No attempt will be made to students in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Nov 2020
- Primary completion30 Jan 2021
- Study completion10 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laughter YogaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zonguldak Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Şule Ecevit Alpar
- Responsible party
- Principal investigator, Canan Eraydın, Zonguldak Bulent Ecevit University
- Investigators
- Şule Ecevit Alpar, Doctorate, Study director, Üniversite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786483
- Sponsor's protocol ID
- 2021/06
- Status last verified
- Mar 2021
- First submitted
- 24 Feb 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31247017Kuru 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.
PubMed 30004172Sahu 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.
PubMed 32377489
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Therapy on Students' Anxiety, Life Satisfaction and Psychological Well-being in the Covid-19 Pandemic
- ClinicalTrials.gov ID
- NCT04786483
- Acronym / sponsor ID
- 2021/06
- Conditions
- Laughter Yoga, Anxiety, Life Satisfaction, Psychological Well-being, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zonguldak Bulent Ecevit UniversityUniversity, hospital or other
- Collaborators
- Prof. Dr. Şule Ecevit Alpar
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 10 May 2021 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter Therapy group | Experimental | Other: Laughter TheraphyAll students enrolled in the laughter therapy group will receive a total of 10 sessions of laughter therapy, 60 minutes, 2 days a week. |
| Control | No intervention | –No attempt will be made to students in this group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter TheraphyAlso: AlternativeLaughter 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 | Laughter Therapy group |
Primary outcome
psychological well-being
Time frame: 4 months
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
Time frame: 4 months
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
Time frame: 4 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Background: PubMed 31247017Morishima 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.
- Background: PubMed 30004172Kuru 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 publication: PubMed 32377489Sahu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şule Ecevit Alpar, Doctorate study director
Üniversite
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Theraphy in people with Laughter Yoga and Anxiety, run by Zonguldak Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
psychological well-being (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04786483, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.