NCT07212348

Brief Summary

The aim of this study is to examine the effect of laughter yoga on well-being and psychological adjustment in first-year midwifery students and to evaluate its potential contributions in the context of adaptation to the educational process. The research is a randomized controlled experimental study. The study will be conducted at the Faculty of Health Sciences, Ağrı İbrahim Çeçen University. The population of the study consists of all students newly enrolled in the Department of Midwifery, Faculty of Health Sciences, Ağrı İbrahim Çeçen University, in the 2025-2026 academic year. No sampling will be carried out; instead, all students who meet the inclusion criteria and volunteer to participate will be included in the study. Participants will be randomly assigned to two groups: the experimental group (who will receive the laughter yoga intervention) and the control group (who will not receive any intervention). Thus, the study will be conducted as a randomized controlled experimental research. The research data will be collected using the General Health Questionnaire, Student Information Form, Subjective Well-Being Scale, Psychological Well-Being Scale, and The Short Version of the Scales of General Well-Being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 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

First Submitted

Initial submission to the registry

September 23, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
2 days until next milestone

Study Start

First participant enrolled

October 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2025

Completed
Last Updated

January 6, 2026

Status Verified

September 1, 2025

Enrollment Period

2 months

First QC Date

September 23, 2025

Last Update Submit

January 3, 2026

Conditions

Keywords

Laughter YogaWell-beingPsychological AdjustmentMidwifery Studentsadaption

Outcome Measures

Primary Outcomes (5)

  • General Health Questionnaire

    The original version of the questionnaire, developed by David Goldberg in 1978, consists of 60 items and is used to determine the level of general psychopathology and to identify psychiatric cases in community surveys. All adaptations show high correlations with each other. .In this study, the GHQ-12, consisting of 12 items, was used. Each item asks about symptoms experienced over the past few weeks and has four response options: "not at all," "no more than usual," "rather more than usual," and "much more than usual." These four options are coded as 0 for "not at all," 1 for "no more than usual," 2 for "rather more than usual," and 3 for "much more than usual," or the administrator reads each item aloud and records the participant's response. In this study, the GHQ-type scoring used in Kılıç's (1996) validity and reliability study was applied. Therefore, participants with a GHQ-12 total score of 2 or higher are considered "cases requiring mental health assessment.

    At the time of study enrollment (baseline)

  • Student Information Form

    Prepared by the researchers based on the literature, it includes questions such as age, parents' educational level, and voluntarily choosing the midwifery program.

    At the time of study enrollment (baseline)

  • Subjective Well-Being Scale

    Developed by Tuzgöl-Dost (2005), the scale aims to determine individuals' levels of subjective well-being by assessing their cognitive evaluations of life and the frequency and intensity of positive and negative emotions experienced. The scale consists of 46 items, 26 of which are positive and 20 negative statements. Negative items are reverse-scored. The total score ranges from 46 to 230, with higher scores indicating higher levels of subjective well-being. The scale uses a five-point Likert format: (5) Completely Agree, (4) Mostly Agree, (3) Partially Agree, (2) Slightly Agree, and (1) Strongly Disagree. To assess reliability, Cronbach's alpha coefficient and the test-retest method were used. Cronbach's alpha reliability coefficient was found to be 0.93, and the test-retest reliability for the entire scale was 0.86. For validity, confirmatory factor analysis showed factor loadings between 0.32 and 0.63.

    At baseline (pre-test), immediately after the intervention (post-test), and at 1-month follow-up

  • Psychological Well-Being Scale

    The Psychological Well-Being Scale was developed by Diener and colleagues (2009-2010) to complement existing well-being measures and to assess socio-psychological well-being. The Turkish adaptation of the scale was conducted by Telef (2011; 2013). Items on the Psychological Well-Being Scale are rated on a 7-point Likert scale, from 1 (strongly disagree) to 7 (strongly agree). All items are positively worded. Total scores range from 8 (if a respondent answers "strongly disagree" to all items) to 56 (if a respondent answers "strongly agree" to all items). Higher scores indicate that the individual possesses multiple psychological resources and strengths.

    At baseline (pre-test), immediately after the intervention (post-test), and at 1-month follow-up

  • The Short Version of the Scales of General Well-Being

    The Short Version of the Scales of General Well-Being (SVSGW) was developed by Longo, Coyne, and Joseph. The validity and reliability of the Turkish version of this scale were established by Kalafatoğlu and Balcı Çelik. The scale is a single-factor instrument consisting of 13 items rated on a five-point Likert scale. The minimum possible score on the scale is 13 and the maximum score is 65. Higher scores indicate a higher level of general well-being. The Cronbach's alpha coefficient of the original scale was reported as 0.90.

    At baseline (pre-test), immediately after the intervention (post-test), and at 1-month follow-up

Study Arms (2)

Experimental

EXPERIMENTAL

Students in the experimental group will participate in laughter yoga sessions conducted twice a week (Thursday and Friday) for four weeks, outside of class hours and in an indoor setting. The sessions will be carried out in subgroups of 9-10 students each, with a total of eight sessions. After completing the eight-session intervention, participants were sent reminder exercises via WhatsApp group for four weeks, and participants provided feedback with emojis as they practiced.

Behavioral: Laughter Yoga

Control

NO INTERVENTION

Students in the control group will not receive any intervention.

Interventions

Laughter YogaBEHAVIORAL

Students in the experimental group will participate in laughter yoga sessions conducted twice a week (Thursday and Friday) for four weeks, outside of class hours and in an indoor setting.

Experimental

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newly enrolled in the Department of Midwifery, Faculty of Health Sciences, Ağrı İbrahim Çeçen University in the 2025-2026 academic year.
  • Willing to participate in the study voluntarily.

You may not qualify if:

  • İndividuals scoring 2 or higher on the GHQ-12.
  • Those with urinary incontinence problems.
  • Individuals who have recently undergone surgical operations.
  • Those who regularly practice yoga, pilates, or similar sports/exercises.
  • Individuals with asthma, COPD, or heart conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ağrı İbrahim Çeçen Üniversitesi

Ağrı, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Rumeysa ÖZAYABAKAN, Asst. Prof.

    Agri Ibrahim Cecen University

    STUDY DIRECTOR
  • Betül UNCU

    İstanbul University-Cerrahpaşa

    PRINCIPAL INVESTIGATOR
  • Ebru SOLMAZ

    Agri Ibrahim Cecen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 8, 2025

Study Start

October 10, 2025

Primary Completion

December 3, 2025

Study Completion

December 3, 2025

Last Updated

January 6, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

Locations