NCT06642727

Brief Summary

The purpose of this clinical trial is to determine the effect of laughter yoga on the burnout levels and stress of nurses. The main questions of the study are as follows:

  1. 1.What is the burnout level of nurses in the control and intervention groups?
  2. 2.What is the stress level of nurses in the control and intervention groups?
  3. 3.Has there been a change in the burnout levels of nurses practicing laughter yoga?
  4. 4.Has there been a change in the stress levels of nurses practicing laughter yoga? To compare whether laughter yoga affects burnout and stress levels, participants will be divided into control and experimental groups. The experimental group will undergo laughter yoga sessions twice a week for one month.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Nov 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Nov 2024Jan 2027

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
17 days until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Expected
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1 month

First QC Date

October 10, 2024

Last Update Submit

October 11, 2024

Conditions

Keywords

BURNOUTstressnurseLaughter Yoga

Outcome Measures

Primary Outcomes (2)

  • Maslach burnout ineventory

    The scale consists of 22 items in a 5-point Likert format (0: Never, 1: Very Rarely, 2: Sometimes, 3: Often, 4: Always). It has three dimensions: Emotional Exhaustion (EE, 9 items), Depersonalization (D, 5 items), and Personal Accomplishment Deficiency (PAD, 8 items). EE refers to the emotional overload an individual feels due to their work and is the most significant predictor of burnout. D represents attitudes and behaviors exhibited by the individual without regard to the fact that the people they serve are unique individuals, displaying a lack of emotion. PAD is defined as the inability to cope with problems successfully and feeling insufficient. Individuals experiencing burnout are expected to have high scores in EE (0-36), D (0-20), and PAD (0-32). The Cronbach Alpha coefficients for the three subdimensions of the scale are 0.83 for emotional exhaustion, 0.65 for depersonalization, and 0.72 for personal accomplishment deficiency.

    1 month

  • Nurse Stress Scale

    The original "Nurse Job Stress Scale," developed by Gray-Toft and Anderson, consists of 34 items and seven factors. These factors include: Uncertainty Related to Treatment (8 items = 1,2,3,4,5,6,7,8), Workload (6 items = 9,10,11,12,13,14), Patient Death (5 items = 15,16,17,18,19), Conflict with Physicians (5 items = 20,21,22,23,24), Conflict with Other Nurses (5 items = 25,26,27,28,29), Inadequate Support (3 items = 30,31,32), and Suffering Patient (2 items = 33,34). It is rated using a 4-point Likert system, where (1 point) means never, (2 points) sometimes, (3 points) often, and (4 points) very often. The Cronbach α reliability coefficient of the original scale has been found to be between α = .89 and α = .65 for the subfactors. A high total score indicates that the nurse experiences more frequent periods of stress related to individual stress issues in the physical, psychological, and environmental contexts.

    1 month

Study Arms (2)

the group undergoing laughter yoga

EXPERIMENTAL

Laughter Yoga is a complementary therapy that combines fake and genuine laughter with yoga and breathing exercises, including neck and shoulder exercises. It does not involve humor and is non-pharmacological and non-invasive. A session of laughter yoga lasts about 40 minutes and consists of four sections. The first section includes deep breathing exercises, the second section consists of warm-up exercises, the third section involves childlike games, and the fourth section includes laughter exercises. The experimental group will consist of 25 participants. Before starting laughter yoga, the "Maslach Burnout Inventory" and the "Nurse Job Stress Scale" will be used to measure burnout and stress levels. Subsequently, a total of eight laughter yoga sessions will be conducted twice a week for one month, after which burnout and stress levels will be measured again using the scales.

Behavioral: laughter yoga

control group

NO INTERVENTION

The control group will consist of 25 participants, whose burnout and stress levels will be measured only using the "Maslach Burnout Inventory" and the "Nurse Job Stress Scale." No intervention will be applied to the participants.

Interventions

laughter yogaBEHAVIORAL

Laughter yoga reduces stress levels through sessions lasting approximately 40 minutes without any invasive or pharmacological interventions. It regulates breathing, relaxes muscles, stimulates circulation, increases pain thresholds, strengthens immunity, lightens the mind, enhances social relationships, promotes mental balance, and boosts self-esteem, hope, energy, and quality of life. The content of a session includes deep breathing exercises, warm-up exercises, childlike games, and laughter exercises.

the group undergoing laughter yoga

Eligibility Criteria

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

You may qualify if:

  • Being a nurse working day and night shifts
  • Not having participated in laughter yoga sessions before
  • Being willing to participate in the study

You may not qualify if:

  • Having a physical condition that prevents participation in laughter yoga sessions (hernia, hemorrhoids, vertigo, respiratory disorders, urinary incontinence, epilepsy)
  • Not being a nurse
  • Working continuously day or continuously night shifts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Mustafakemalpaşa Public Hospital

Bursa, Mustafakemalpaşa, 16500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: There will be two groups: an experimental group and a control group. The experimental group will undergo laughter yoga, while the control group will not receive any intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
student

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

November 1, 2024

Primary Completion

December 1, 2024

Study Completion (Estimated)

January 1, 2027

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations