NCT06350747

Brief Summary

The planned study aims to contribute to the existing literature by comparatively evaluating the effects of online and face-to-face laughter yoga interventions on nurses, focusing on stress, sleep quality, and burnout. In line with this purpose, the research hypotheses are as follows: H1. Laughter yoga intervention provided to nurses has a positive effect on their perceived stress levels. H2. Laughter yoga intervention provided to nurses has a positive effect on their sleep quality. H3. Laughter yoga intervention provided to nurses has a positive effect on their burnout levels. H4. There is a significant difference between the effects of online and face-to-face laughter yoga interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2024

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

March 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2025

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

11 months

First QC Date

March 30, 2024

Last Update Submit

May 15, 2025

Conditions

Keywords

burnout levellaughter yoganursesstresssleep quality

Outcome Measures

Primary Outcomes (3)

  • Perceived Stress Scale

    ASQ is designed to measure how stressful some situations in a person's life are perceived. A total score of 0-32 is taken from the scale. It has two subscales: perceived stress (items 1, 2, 3, 7, 8) and perceived coping (items 4, 5, and 6). The scale is evaluated on both total score and subscale scores. A high total score means a high perceived stress level. High scores from the subscales are a negative situation.

    two week and three week after intervention

  • Jenkins Sleep Scale

    It is used in clinical studies to evaluate patients' sleep problems. Patients are asked 4 questions about their sleep problems in the last month and asked to tick the boxes that apply to them. 0 (almost never), 1 (1-3 days per month), 2 (4-7 days per month), 3 (8-14 days per month), 4 (15-21 days per month), 5 (23-31 days per month) It is evaluated as . An increase in the score indicates that the person's sleep quality decreases.

    two week and three week after intervention

  • Maslach Burnout Scale

    This measurement tool consists of a total of 22 items and three subscales. Among these subscales, the emotional exhaustion subscale consists of 9 items, the depersonalization subscale consists of 5 items, and the personal accomplishment subscale consists of a total of 8 items. Scale items are scored as "1: never" and "7: always". It was decided to arrange the scale as a five-degree scale, with the answer options being "0 never" and "4 always". The high level of burnout reflects the high score on the emotional exhaustion and depersonalization subscales and the low score on the personal accomplishment subscale. Moderate levels of burnout reflect moderate scores for all three subscales, while low levels reflect low scores on the emotional exhaustion and depersonalization subscales and high scores on the "personal accomplishment" subscale.

    two week and three week after intervention

Study Arms (3)

Control Group

OTHER

Participants in this group did not receive any intervention during the study period. They only completed the pre- and post-intervention assessments. After study completion, they were offered a single optional laughter yoga session.

Other: control group

Face-to-Face Laughter Yoga Group

EXPERIMENTAL

Participants in this group attended four sessions of laughter yoga conducted in person by certified instructors. Sessions lasted approximately 40 minutes and were held twice a week for two weeks in groups of 5-6 nurses.This intervention included hand clapping and warm-up exercises, deep breathing, playful games, and laughter exercises. Delivered in-person, each session lasted 30-40 minutes and followed a standardized format developed by Dr. Madan Kataria.

Behavioral: Face-to-Face Laughter Yoga Group

Online Laughter Yoga Group

EXPERIMENTAL

Participants in this group received the same laughter yoga intervention as the face-to-face group, but it was delivered online via Zoom. Sessions were held in the evening hours twice a week over two weeks.This intervention followed the same structure as the face-to-face program, including clapping, breathing, and laughter exercises. Sessions were conducted in real time via Zoom by certified laughter yoga instructors.

Behavioral: Online Laughter Yoga Group

Interventions

In this study, each laughter yoga session lasted approximately 30-40 minutes and consisted of four parts: hand clapping and warm-up exercises, deep breathing exercises, playful games, and laughter exercises. According to Kataria (2011), the first three parts remained consistent across all sessions, while the laughter exercises in the fourth part varied (Kataria 2011). In the first session of each new group, participants were introduced to laughter yoga, its purpose, and objectives, with 10 minutes allocated to this introductory section. As a result, the first session for each group lasted 40 minutes, while the remaining sessions were 30 minutes each. The structure and duration of each session were as follows: * Section 1: Hand Clapping and Warm-up Exercises - 5 minutes * Section 2: Deep Breathing Exercises - 10 minutes * Section 3: Playful Games - 5 minutes * Section 4: Laughter Exercises - 10 minutes

Face-to-Face Laughter Yoga Group

In this study, each laughter yoga session lasted approximately 30-40 minutes and consisted of four parts: hand clapping and warm-up exercises, deep breathing exercises, playful games, and laughter exercises. According to Kataria (2011), the first three parts remained consistent across all sessions, while the laughter exercises in the fourth part varied (Kataria 2011). In the first session of each new group, participants were introduced to laughter yoga, its purpose, and objectives, with 10 minutes allocated to this introductory section. As a result, the first session for each group lasted 40 minutes, while the remaining sessions were 30 minutes each. The structure and duration of each session were as follows: * Section 1: Hand Clapping and Warm-up Exercises - 5 minutes * Section 2: Deep Breathing Exercises - 10 minutes * Section 3: Playful Games - 5 minutes * Section 4: Laughter Exercises - 10 minutes

Online Laughter Yoga Group

Participants in the control group will not receive the laughter yoga intervention. They will continue with their usual daily routines and will only complete pre- and post-test assessments.

Control Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • working as a nurse
  • over 18 years old

You may not qualify if:

  • No uncontrolled hypertension
  • No history of abdominal surgery in the last three months
  • Not suffering from glaucoma, hernia or epilepsy
  • Not receiving psychiatric diagnosis and treatment
  • Not receiving sleep-related diagnosis and treatment
  • having incontinence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi

Manisa, 45060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Özge TOPSAKAL

    Manisa Celal Bayar University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: pretest-posttest with control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 5, 2024

Study Start

April 1, 2024

Primary Completion

February 10, 2025

Study Completion

March 10, 2025

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations