NCT07540039

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 20, 2026

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

1 month

First QC Date

November 27, 2025

Last Update Submit

April 16, 2026

Conditions

Keywords

Laughter YogaPerceived StressSelf-EfficacyNursing Students

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    At baseline and post-intervention (week 4 )

Secondary Outcomes (1)

  • Self-Efficacy Level

    At baseline and post-intervention (Week 4)

Study Arms (2)

experiment

EXPERIMENTAL

Participants in the intervention group received laughter yoga sessions twice a week for a total of four weeks.

Other: laughter yoga

Standard Education

ACTIVE COMPARATOR

No application was made to the control group, standard procedure was followed.

Other: laughter yoga

Interventions

Laughter yoga will be applied to nursing students to reduce stress levels and improve bio-psychosocial responses. The control group will receive traditional training.

Standard Educationexperiment

Eligibility Criteria

Age17 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale University Rectorate Ankara Road 7.Km 71450 Yahşihan/ KIRIKKALE

Kirikkale, Kırıkkale Yahşihan, 71450, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • BEYZA KALKAN KALKAN, license

    Kırıkkale University

    PRINCIPAL INVESTIGATOR
  • KALKAN

    Kırıkkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 27, 2025

First Posted

April 20, 2026

Study Start

February 27, 2025

Primary Completion

April 10, 2025

Study Completion

April 10, 2025

Last Updated

April 20, 2026

Record last verified: 2026-04

Locations