- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540039
LaughterYogaStress (Laughter yoga)
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).
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kırıkkale Yahşihan
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Kirikkale, Kırıkkale Yahşihan, Turkey (Türkiye), 71450
- Kırıkkale University Rectorate Ankara Road 7.Km 71450 Yahşihan/ KIRIKKALE
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experiment
Participants in the intervention group received laughter yoga sessions twice a week for a total of four weeks.
|
Laughter yoga will be applied to nursing students to reduce stress levels and improve bio-psychosocial responses.
The control group will receive traditional training.
|
|
Active Comparator: Standard Education
No application was made to the control group, standard procedure was followed.
|
Laughter yoga will be applied to nursing students to reduce stress levels and improve bio-psychosocial responses.
The control group will receive traditional training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
At baseline and post-intervention (Week 4)
|
|
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. |
At baseline and post-intervention (week 4)
|
|
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. |
At baseline and post-intervention (week 4 )
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Efficacy Level
Time Frame: At baseline and post-intervention (Week 4)
|
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 |
At baseline and post-intervention (Week 4)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: BEYZA KALKAN KALKAN, license, Kırıkkale University
- Principal Investigator: KALKAN, Kırıkkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- KUSBFBK01
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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