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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06350747
Other study ID # CelalBayarU-SBF-OT-02
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date July 30, 2024

Study information

Verified date April 2024
Source Celal Bayar University
Contact Özge TOPSAKAL, PhD
Phone 05549165599
Email ozgebydr_19@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study was to investigate the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels.


Description:

In the literature, it has been found that laughter yoga improves mental health and respiratory functions, positively influences sleep, reduces stress, creates positive mood, enhances cognitive functions, reduces pain, and facilitates circulation. Nurses are a high-risk occupational group for stress, sleep problems, and burnout due to their working conditions and patient care burdens. The aim of this planned study is to examine the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels. The sample size for the experimental study, which will be conducted as a pre-test post-test control group design, was calculated using the G*Power 3.1.9.7 program. Sample size calculation was performed for the independent-samples t-test. The effect size used in the calculation was based on the results of the study conducted by Çelik and Kılınç (2022). With an effect size of 2.20 (d = 2.20), a 5% error margin (α = 0.05), and 95% power (1-β = 0.95), the sample size for each group was calculated as 6. However, considering the high effect size obtained from the reference study, a recommended effect size of 0.80 (d = 0.50), a 5% error margin (α = 0.05), and 80% power (1-β = 0.80) were used, resulting in a sample size of 26 for each group. Taking into account the possibility of data loss, the sample size for each group was increased by 20%, and a total of 64 participants, with 32 participants in each group, were planned to be included in the sampling. Nurses participating in the study will be stratified according to the units they work in (internal and surgical units) and randomized. In data collection, the Demographic Characteristics Questionnaire, Perceived Stress Scale, Jenkins Sleep Scale, and Maslach Burnout Scale will be used. For data analysis, number percentage distribution and descriptive statistics will be used to describe demographic characteristics. Differences between basic descriptive characteristics of nurses in the experimental and control groups will be analyzed using Chi-square and Fisher's exact tests. The relationship between the scale score averages of the experimental and control groups will be analyzed using independent-samples t-tests and the Mann-Whitney U test.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date July 30, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - working as a nurse - over 18 years old Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Laughter Yoga
A laughter yoga session lasts approximately 30 minutes and consists of four parts. These parts are hand clapping and warm-up exercises, deep breathing exercises, playful games, and laughter exercises. The sections of laughter yoga are explained below (Kataria, 2011). Each laughter yoga session includes the same first three parts, with variations in the laughter exercises in the fourth part. In each new group, the first session will introduce participants to laughter yoga, its purpose, and objectives. Ten minutes are allocated for this section in the first session of each group. Therefore, the first sessions are 40 minutes long in each group, while all subsequent sessions are 30 minutes long. The total duration of the session, broken down by section, is 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

Locations

Country Name City State
Turkey Manisa Celal Bayar Üniversitesi Hafsa Sultan Hastanesi Manisa

Sponsors (1)

Lead Sponsor Collaborator
Celal Bayar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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