NCT07062029

Brief Summary

The goal of this clinical trial is to learn if laughter yoga sessions improve spiritual well-being and perception of spiritual care among nursing students. The main questions it aims to answer are: Does laughter yoga increase the spiritual well-being scores of participants? Does laughter yoga improve participants' perception of spiritual care? Researchers will compare laughter yoga to no intervention (control group) to see if laughter yoga has an effect on spiritual well-being and spiritual care perception. Participants will: Attend laughter yoga sessions once a week for 4 weeks (intervention group) Complete questionnaires about their spiritual well-being and perception of spiritual care before and after the intervention Control group will not receive any intervention during this period, but will complete the same questionnaires at the same time points

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

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

September 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
Last Updated

July 14, 2025

Status Verified

July 1, 2025

Enrollment Period

1 month

First QC Date

July 2, 2025

Last Update Submit

July 11, 2025

Conditions

Keywords

NursingSpiritual- Well Beingspiritual carelaugther yoga

Outcome Measures

Primary Outcomes (1)

  • Change in Spiritual Well-Being Score

    Spiritual well-being will be measured using the Three-Factor Spiritual Well-Being Scale, which has a total score range from 29 to 145, with higher scores indicating greater spiritual well-being.

    1 week before intervention (baseline) and 1 week after completing the fourth session (Week 5)

Secondary Outcomes (1)

  • Change in Spirituality and Spiritual Care Rating Scale Score

    1 week before intervention (baseline) and 1 week after completing the fourth session (Week 5)

Study Arms (2)

Laughter Yoga Intervention

EXPERIMENTAL

Participants in this arm will attend laughter yoga sessions once a week for 4 weeks. Each session will last approximately 30 minutes and will be conducted by a certified laughter yoga leader in a quiet classroom environment where participants can move freely. The intervention aims to improve spiritual well-being and perception of spiritual care among nursing students.

Other: Laughter Yoga

Control Group

NO INTERVENTION

Participants in this arm will not receive any intervention during the 4-week study period. They will complete the same pretest and posttest questionnaires as the intervention group, at the same time points, to evaluate their spiritual well-being and perception of spiritual care.

Interventions

The laughter yoga intervention consists of four sessions conducted once a week for four weeks. Each session lasts approximately 30 minutes and includes four components: * Warm-up exercises with clapping and rhythmic movements * Deep breathing exercises * Childlike playful activities and laughter exercises * Laughter meditation and relaxation Sessions are led by a certified laughter yoga leader in a quiet classroom setting that allows participants to move freely and comfortably. The intervention is designed to improve spiritual well-being and perception of spiritual care among nursing students.

Laughter Yoga Intervention

Eligibility Criteria

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

You may qualify if:

  • Being a third- or fourth-year nursing student enrolled in the Faculty of Health Sciences, Department of Nursing at Izmir Demokrasi University during the 2024-2025 academic year
  • Volunteering to participate in the study

You may not qualify if:

  • Irregular attendance to the intervention sessions
  • Failure to complete all sessions
  • Voluntary withdrawal from the study
  • Having a diagnosis of a respiratory disease (e.g., asthma, bronchitis, dyspnea)
  • Having a diagnosis of inguinal hernia or epilepsy
  • Having undergone abdominal surgery within the last three to six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Izmir Democracy University

Izmir, Konak, 35250, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Sadiye Associate Professor, PhD

    Izmir Democracy University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was a randomized controlled trial with intervention and control groups. Sixty 3rd- and 4th-year nursing students provided informed consent and were randomized using randomizer.org and the URN method by drawing colored balls (green=intervention, white=control). The intervention group attended laughter yoga sessions twice a week for 4 weeks (each \~30 mins) led by a certified laughter yoga leader in a quiet, temperature-controlled lab suitable for movement. Sessions included warm-up, breathing, playful activities, and laughter exercises. Before the first session, students received an educational presentation and brochure. The control group received no intervention. Data were collected using the Spirituality and Spiritual Care Rating Scale and Three-Factor Spiritual Well-Being Scale 1 week before and 1 week after intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 2, 2025

First Posted

July 14, 2025

Study Start

September 20, 2024

Primary Completion

October 21, 2024

Study Completion

November 25, 2024

Last Updated

July 14, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the data are part of a thesis study with limited scope and there is no current plan or institutional repository available for data sharing. Additionally, participant privacy and confidentiality cannot be ensured for sharing de-identified data at this time.

Locations