Laughter YogaLaughter yogaNCT07540039
LaughterYogaStress
A study testing laughter yoga in people with Laughter Yoga and Perceived Stress, run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
It is important for students to develop effective coping behaviors to manage stress, as this contributes to the formation of a positive professional identity. Studies have shown that stress negatively affects student success (Chapman and Orb, 2001; Chan, So, and Fong, 2009). Read more about this study
- Who is it for?
- Ages 17 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga, Perceived Stress, Self-Efficacy
- What is being tested?
- laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Feb 2025to 10 Apr 2025
- 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 17 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being a first-year nursing student
- Enrolled in the Fundamentals of Nursing course for the first time
- Volunteering to participate in the study
- No history of psychiatric diagnosis
Who cannot join
- Previous education in any health-related field
- Prior enrollment in the Fundamentals of Nursing course
- History of psychiatric disorders
- Diagnosis of diabetes mellitus, hypertension, hypothyroidism, or hyperthyroidism
- Pregnancy
- History of malignancy
Show all 14Show fewer
- Congestive heart failure
- Psychotic disorders
- Chronic liver or kidney failure
- Nephrotic syndrome
- Continuous medication use (e.g., ACE inhibitors, ARBs, phenytoin, barbiturates, oral contraceptives)
- Surgery within the last 3 months
- Uncontrolled hypertension
- Glaucoma, hernia, or epilepsy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kırıkkale University Rectorate Ankara Road 7.Km 71450 Yahşihan/ KIRIKKALE
Kirikkale, Kırıkkale Yahşihan, 71450
About this study
Official title: The Effect of Laughter Yoga on Clinical Stress and Self-Efficacy Levels of First-Year Nursing Students
It is important for students to develop effective coping behaviors to manage stress, as this contributes to the formation of a positive professional identity. Studies have shown that stress negatively affects student success (Chapman and Orb, 2001; Chan, So, and Fong, 2009). First-year nursing students may particularly experience difficulties in performing clinical practice for the first time and communicating with healthcare professionals (Ağaçdiken et al., 2016; Pryjmachuk and Richards, 2007).
Self-efficacy is one of the key factors determining how individuals handle and cope with stressful situations, and it serves as a protective factor in stress management. Various methods are used to cope with stress. In the Traditional Medicine Strategy report published by the World Health Organization, yoga is identified as a complementary medicine practice (WHO, 2013b).
Read more
Laughter yoga is an exercise program that combines unconditional laughter with breathing techniques and is considered a non-invasive and non-pharmacological intervention (Strean, 2009). It activates muscles through laughter-related movements, enhances blood circulation, and contributes to reducing stress hormone levels (Yim, 2016). Therefore, laughter yoga will be used in this study to help students cope with stress and improve their self-efficacy levels.
This study is designed as a randomized controlled trial with an experimental and a control group, using a pre-test, post-test, and follow-up design. The population of the study will consist of first-year nursing students at Kırıkkale University, Faculty of Health Sciences, during the 2024-2025 academic year.
Data will be collected using an introductory characteristics form, the Perceived Stress Scale for Nursing Students, the Bio-Psycho-Social Response Scale for Nursing Students, the Stress Coping Behaviors Scale for Nursing Students, and the General Self-Efficacy Scale. Data analysis will be conducted using SPSS for Windows 22. Descriptive statistics will be used for all variables. The chi-square test will be applied to compare sociodemographic characteristics between groups, and the independent samples t-test will be used to compare differences between two independent groups.
Read the detailed description
This study aims to evaluate the effect of laughter yoga on clinical stress and self-efficacy levels among first-year nursing students. Clinical stress is a common challenge in early nursing education and may negatively affect students' performance, confidence, and adaptation to clinical practice. Supporting students in managing stress and improving self-efficacy is important for both educational outcomes and patient safety.
The study is designed as a randomized controlled trial with experimental and control groups using a pre-test, post-test, and follow-up design. The study will be conducted among first-year nursing students at Kırıkkale University Faculty of Health Sciences during the 2024-2025 academic year.
The intervention will consist of a structured laughter yoga program delivered by a certified laughter yoga leader. The program will be implemented over four weeks, with two sessions per week, resulting in a total of eight sessions. Each session will last approximately 40 minutes and will be conducted in a classroom setting suitable for group activities.
Each session will include four main components. The first component consists of clapping and warm-up exercises performed in a rhythmic and synchronized manner to increase energy and group interaction. The second component includes deep breathing exercises involving controlled inhalation and prolonged exhalation to promote relaxation. The third component consists of playful group activities designed to encourage spontaneity and engagement. The fourth component includes guided laughter exercises in which participants simulate laughter through structured activities to stimulate genuine laughter responses. Sessions will end with brief relaxation exercises.
The control group will receive standard clinical orientation procedures without any additional intervention during the study period.
Data will be collected at three different time points: before the intervention, immediately after the intervention, and at the end of the clinical practice period.
Data analysis will be conducted using appropriate statistical methods. Descriptive statistics will be used to summarize the data, and group comparisons will be performed using suitable statistical tests. Statistical significance will be accepted at p<0.05.
The study will be conducted in accordance with ethical principles. Participants will be informed about the study and their voluntary participation will be ensured. Confidentiality of the data will be protected, and participants will have the right to withdraw from the study at any time. Ethical approval and institutional permissions will be obtained before the study begins.
The study is planned to be conducted between February 2024 and July 2024. There is no conflict of interest, and all expenses related to the study will be covered by the researchers.
- Conditions
- Laughter Yoga, Perceived Stress, Self-Efficacy, Nursing Students
- Being tested
- laughter yoga
- Keywords
- Laughter Yoga, Perceived Stress, Self-Efficacy, Nursing Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter yogaOther
Laughter yoga will be applied to nursing students to reduce stress levels and improve bio-psychosocial responses. The control group will receive traditional training.
| Study group | Role | What they receive |
|---|---|---|
| experiment | Experimental | Participants in the intervention group received laughter yoga sessions twice a week for a total of four weeks. Receives: Other: laughter yoga |
| Standard Education | Active comparator | No application was made to the control group, standard procedure was followed. Receives: Other: laughter yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress Level
Perceived stress levels of nursing students will be assessed using the Perceived Stress Scale for Nursing Students.
Assessments will be conducted at baseline and after the intervention (4th week).
Higher scores indicate higher levels of perceived stress.
Measured: At baseline and post-intervention (Week 4)
Biopsychosocial Response
Biopsychosocial responses of nursing students will be evaluated using the Biopsychosocial Response Scale for Nursing Students.
Assessments will be conducted at baseline and after the intervention (4th week).
Higher scores indicate more negative biopsychosocial responses.
Measured: At baseline and post-intervention (week 4)
Coping with Stress
Coping behaviors of nursing students will be assessed using the Coping with Stress Scale for Nursing Students.
Assessments will be conducted at baseline and after the intervention (4th week).
Higher scores indicate better coping with stress.
Measured: At baseline and post-intervention (week 4 )
Secondary outcomes (1)
Self-Efficacy Level
Self-efficacy levels of nursing students will be measured using the General Self-Efficacy Scale.
Assessments will be conducted at baseline and after the intervention (4th week).
Higher scores indicate higher self-efficacy
Measured: At baseline and post-intervention (Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start27 Feb 2025
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beyza Kalkan, Kırıkkale University
- Investigators
- BEYZA KALKAN KALKAN, license, Principal investigator, Kırıkkale UniversityKALKAN, Principal investigator, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540039
- Sponsor's protocol ID
- KUSBFBK01
- Acronym
- Laughter yoga
- Status last verified
- Apr 2026
- First submitted
- 27 Nov 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Clinical Stress and Self-Efficacy Levels of First-Year Nursing Students
- ClinicalTrials.gov ID
- NCT07540039
- Acronym / sponsor ID
- Laughter yoga / KUSBFBK01
- Conditions
- Laughter Yoga, Perceived Stress, Self-Efficacy, Nursing Students
- Keywords
- Laughter Yoga, Perceived Stress, Self-Efficacy, Nursing Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 20 Apr 2026 (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.
It is important for students to develop effective coping behaviors to manage stress, as this contributes to the formation of a positive professional identity. Studies have shown that stress negatively affects student success (Chapman and Orb, 2001; Chan, So, and Fong, 2009). First-year nursing students may particularly experience difficulties in performing clinical practice for the first time and communicating with healthcare professionals (Ağaçdiken et al., 2016; Pryjmachuk and Richards, 2007).
Self-efficacy is one of the key factors determining how individuals handle and cope with stressful situations, and it serves as a protective factor in stress management. Various methods are used to cope with stress. In the Traditional Medicine Strategy report published by the World Health Organization, yoga is identified as a complementary medicine practice (WHO, 2013b).
Laughter yoga is an exercise program that combines unconditional laughter with breathing techniques and is considered a non-invasive and non-pharmacological intervention (Strean, 2009). It activates muscles through laughter-related movements, enhances blood circulation, and contributes to reducing stress hormone levels (Yim, 2016). Therefore, laughter yoga will be used in this study to help students cope with stress and improve their self-efficacy levels.
This study is designed as a randomized controlled trial with an experimental and a control group, using a pre-test, post-test, and follow-up design. The population of the study will consist of first-year nursing students at Kırıkkale University, Faculty of Health Sciences, during the 2024-2025 academic year.
Data will be collected using an introductory characteristics form, the Perceived Stress Scale for Nursing Students, the Bio-Psycho-Social Response Scale for Nursing Students, the Stress Coping Behaviors Scale for Nursing Students, and the General Self-Efficacy Scale. Data analysis will be conducted using SPSS for Windows 22. Descriptive statistics will be used for all variables. The chi-square test will be applied to compare sociodemographic characteristics between groups, and the independent samples t-test will be used to compare differences between two independent groups.
Detailed description
This study aims to evaluate the effect of laughter yoga on clinical stress and self-efficacy levels among first-year nursing students. Clinical stress is a common challenge in early nursing education and may negatively affect students' performance, confidence, and adaptation to clinical practice. Supporting students in managing stress and improving self-efficacy is important for both educational outcomes and patient safety.
The study is designed as a randomized controlled trial with experimental and control groups using a pre-test, post-test, and follow-up design. The study will be conducted among first-year nursing students at Kırıkkale University Faculty of Health Sciences during the 2024-2025 academic year.
The intervention will consist of a structured laughter yoga program delivered by a certified laughter yoga leader. The program will be implemented over four weeks, with two sessions per week, resulting in a total of eight sessions. Each session will last approximately 40 minutes and will be conducted in a classroom setting suitable for group activities.
Each session will include four main components. The first component consists of clapping and warm-up exercises performed in a rhythmic and synchronized manner to increase energy and group interaction. The second component includes deep breathing exercises involving controlled inhalation and prolonged exhalation to promote relaxation. The third component consists of playful group activities designed to encourage spontaneity and engagement. The fourth component includes guided laughter exercises in which participants simulate laughter through structured activities to stimulate genuine laughter responses. Sessions will end with brief relaxation exercises.
The control group will receive standard clinical orientation procedures without any additional intervention during the study period.
Data will be collected at three different time points: before the intervention, immediately after the intervention, and at the end of the clinical practice period.
Data analysis will be conducted using appropriate statistical methods. Descriptive statistics will be used to summarize the data, and group comparisons will be performed using suitable statistical tests. Statistical significance will be accepted at p<0.05.
The study will be conducted in accordance with ethical principles. Participants will be informed about the study and their voluntary participation will be ensured. Confidentiality of the data will be protected, and participants will have the right to withdraw from the study at any time. Ethical approval and institutional permissions will be obtained before the study begins.
The study is planned to be conducted between February 2024 and July 2024. There is no conflict of interest, and all expenses related to the study will be covered by the researchers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experiment | Experimental | Other: laughter yogaParticipants in the intervention group received laughter yoga sessions twice a week for a total of four weeks. |
| Standard Education | Active comparator | Other: laughter yogaNo application was made to the control group, standard procedure was followed. |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Being a first-year nursing student
- Enrolled in the Fundamentals of Nursing course for the first time
- Volunteering to participate in the study
- No history of psychiatric diagnosis
Key exclusion criteria (14 listed)
- Previous education in any health-related field
- Prior enrollment in the Fundamentals of Nursing course
- History of psychiatric disorders
- Diagnosis of diabetes mellitus, hypertension, hypothyroidism, or hyperthyroidism
- Pregnancy
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 yogaLaughter yoga will be applied to nursing students to reduce stress levels and improve bio-psychosocial responses. The control group will receive traditional training. | Other | Standard Education, experiment |
Primary outcome
Perceived Stress Level
Time frame: At baseline and post-intervention (Week 4)
Perceived stress levels of nursing students will be assessed using the Perceived Stress Scale for Nursing Students. Assessments will be conducted at baseline and after the intervention (4th week). Higher scores indicate higher levels of perceived stress.
Biopsychosocial Response
Time frame: At baseline and post-intervention (week 4)
Biopsychosocial responses of nursing students will be evaluated using the Biopsychosocial Response Scale for Nursing Students. Assessments will be conducted at baseline and after the intervention (4th week). Higher scores indicate more negative biopsychosocial responses.
Coping with Stress
Time frame: At baseline and post-intervention (week 4 )
Coping behaviors of nursing students will be assessed using the Coping with Stress Scale for Nursing Students. Assessments will be conducted at baseline and after the intervention (4th week). Higher scores indicate better coping with stress.
1 secondary outcome
Self-Efficacy Level
Time frame: At baseline and post-intervention (Week 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
BEYZA KALKAN KALKAN, license principal investigator
Kırıkkale University
KALKAN principal investigator
Kırıkkale University
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 yoga in people with Laughter Yoga and Perceived Stress, run by Kırıkkale 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 20 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Perceived Stress Level (time frame: At baseline and post-intervention (Week 4)). 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?
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 20 Apr 2026.