NCT05301244

Brief Summary

This study aimed to determine the effects of laughter yoga on the psychological resilience and sleep quality of active nurses during the pandemic period. Initial stage of labor on randomized controlled birth outcomes and maternal satisfaction. A total of 100 nurses, determined by power analysis, were recruited into the randomized controlled, single-blind clinical study. The study included 2 groups (group A nurses who had active contact with patients diagnosed with or at risk of covid-19, group B: nurses who had active contact with patients diagnosed or at risk of covid-19 and participated in laughter yoga practice. Laughter yoga; immune system It has been proven by experimental studies that there is a connection between antibodies and endorphins, that it has a healing effect, that it accelerates the circulatory system as an adverse effect to stress, and that it has a vasodilation effect in the vessels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 24, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 29, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

March 18, 2022

Last Update Submit

March 29, 2022

Conditions

Keywords

Nurse, laughter yoga

Outcome Measures

Primary Outcomes (3)

  • Introductory Information Form (questionnaire)

    The form prepared by the researchers consists of a total of 13 questions, including some demographic characteristics (age, education level, marital status, etc.) and professional characteristics (working years, frequently worked shifts, clinic/unit worked during the epidemic period, etc.) of the nurses.

    up to 2 weeks

  • Connor-Davidson Resilience Scale (CD-RISC)-pre-test

    The scale consists of 25 items and has a 5-point Likert type scoring ranging from 'never true' (0) to 'always true' (4). Scale; It consists of three sub-dimensions, namely perseverance and personal competence, tolerance to negative phenomena, and spiritual inclination, and the total score to be taken from the scale is minimum 0 and maximum 100 points. High scores obtained from the scale indicate high levels of psychological resilience. According to the factor structure, perseverance and personal competence with items 1, 5, 10, 11, 12, 15, 16, 17, 18, 19, 21, 22, 23, 24, 25; Resilience levels can be determined by examining tolerance to negative events with items 4, 6, 7, 8, 13, 14, and moral tendency with items 2, 3, 9, 20. The Cronbach's alpha coefficient of the scale was stated as 0.89. In this study, the Cronbach's alpha coefficient of the scale was calculated as 0.92.

    up to 5 weeks

  • Pittsburgh Sleep Quality Index (PSQI)-pre-test

    In the form consisting of a total of 24 questions, scores of 7 components are obtained. PSQI; It consists of seven sub-components that evaluate subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping pills, and dysfunction during the day. The response of each is scored between 0-3 according to symptom frequency. The sum of the scores of the seven components gives the total PSQI score. The total score obtained varies between 0-21, and high values indicate poor sleep quality and high sleep disturbance level. A total score of 6 or above indicates that the sleep quality is clinically significantly worse. The Cronbach Alpha internal consistency coefficient of the scale was found to be 0.80. In this study, the Cronbach's alpha coefficient of the PSQI Scale was calculated as 0.83.

    up to 5 weeks

Secondary Outcomes (2)

  • Connor-Davidson Resilience Scale (CD-RISC)-post-application testing

    up to 5 weeks

  • Pittsburgh Sleep Quality Index (PSQI)-post-application testing

    up to 5 weeks

Study Arms (5)

laughter yoga practice

EXPERIMENTAL

Laughter yoga practiced by a researcher with a laughter yoga practitioner certificate

Other: laughter yoga for nursesOther: laughter yoga for nurses-Deep breathing exercisesOther: laughter yoga for nurses-Warm-up exercisesOther: laughter yoga for nurses-Childish gamesOther: laughter yoga for nurses-Laughter exercises

Laughter yoga session parts-1

EXPERIMENTAL

Deep breathing exercises (5 minutes)

Other: laughter yoga for nursesOther: laughter yoga for nurses-Deep breathing exercisesOther: laughter yoga for nurses-Warm-up exercisesOther: laughter yoga for nurses-Childish gamesOther: laughter yoga for nurses-Laughter exercises

Laughter yoga session parts-2

EXPERIMENTAL

Warm-up exercises (10 minutes)

Other: laughter yoga for nursesOther: laughter yoga for nurses-Deep breathing exercisesOther: laughter yoga for nurses-Warm-up exercisesOther: laughter yoga for nurses-Childish gamesOther: laughter yoga for nurses-Laughter exercises

Laughter yoga session parts-3

EXPERIMENTAL

Childish games (10 minutes)

Other: laughter yoga for nursesOther: laughter yoga for nurses-Deep breathing exercisesOther: laughter yoga for nurses-Warm-up exercisesOther: laughter yoga for nurses-Childish gamesOther: laughter yoga for nurses-Laughter exercises

Laughter yoga session parts-4

EXPERIMENTAL

Laughter exercises (15 minutes)

Other: laughter yoga for nursesOther: laughter yoga for nurses-Deep breathing exercisesOther: laughter yoga for nurses-Warm-up exercisesOther: laughter yoga for nurses-Childish gamesOther: laughter yoga for nurses-Laughter exercises

Interventions

The experimental group was divided into three groups as 17-17-16 people. For four weeks, laughter yoga sessions were held between 20.00 and 21.00, 2 days a week for each group. Laughter yoga sessions were held for the 1st group between 20.00-21.00 on Mondays and Thursdays, for the 2nd group between 20.00-21.00 on Tuesdays and Fridays, and for the 3rd group between 20.00-21.00 on Wednesdays and Sundays. The first sessions lasted 45 minutes, every other session 40 minutes.

Laughter yoga session parts-1Laughter yoga session parts-2Laughter yoga session parts-3Laughter yoga session parts-4laughter yoga practice

Deep breathing exercises (5 minutes) Breathing is held for 4-5 seconds after deep inspiration. While the arms are brought to the normal position, exhale slowly and rhythmically. When expressing after deep inspiration, the lips can be pursed as if whistling or exhaled with laughter.

Laughter yoga session parts-1Laughter yoga session parts-2Laughter yoga session parts-3Laughter yoga session parts-4laughter yoga practice

Warm-up exercises (10 minutes) Rhythm of 1-2, 1-2-3 is added to increase the energy level even more and synchronize the movements of the group. After a few rhythmic clapping movements, another movement is added. Whisking hands left and right. Then an audible rhythm of ho, ho, ha-ha-ha is added to the clapping gesture. Make eye contact with people in the group and smile at them.

Laughter yoga session parts-1Laughter yoga session parts-2Laughter yoga session parts-3Laughter yoga session parts-4laughter yoga practice

Childish games (10 minutes) Childlike games are used to help laugh without reason just like a child. The group is motivated by visualizing these games in their minds, raising the arms up in the form of a "Y" letter, and saying "very good (applause), very good (applause), hey" with palms facing the sky.

Laughter yoga session parts-1Laughter yoga session parts-2Laughter yoga session parts-3Laughter yoga session parts-4laughter yoga practice

Laughter exercises (15 minutes) This section includes a variety of laughter exercises such as greetings, strawberry milk, conductor, bonus, hot soup, lion, aloha, bird, appreciation, laughter lotion, elevator, cream cake, and bursting balloon laughter.

Laughter yoga session parts-1Laughter yoga session parts-2Laughter yoga session parts-3Laughter yoga session parts-4laughter yoga practice

Eligibility Criteria

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

You may qualify if:

  • Not have undergone abdominal surgery in the past three months
  • Not have uncontrolled hypertension
  • Not have epilepsy
  • Not have received a psychiatric diagnosis or treatment
  • Working actively during the pandemic period

You may not qualify if:

  • Not attending sessions regularly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Süheyla Yaralı

Yakutiye, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laughter TherapyNurses

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsHealth PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Experiment and control groups were not clearly stated in the outcome evaluation. Coded as A-B.The person making the assessment was not informed about this.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 29, 2022

Study Start

June 24, 2021

Primary Completion

August 15, 2021

Study Completion

August 31, 2021

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations