Effect of Laughter Yoga on Mental Symptoms Frequency and Level of Saliva Cortisol

January 21, 2019 updated by: Fatma Ozlem Ozturk, Ankara University

The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.

This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to evaluate the effect of laughter yoga on mental symptom frequency and salivary cortisol level among the 1st Year Nursing Students.

This is a randomized controlled study using pre-post-test design with control group. The population of our research; Ankara University Faculty of Health Sciences Nursing Department consisting of 202 students studying at the First Year. A descriptive question form will apply to the entire population of the research.191 students fulfilling the criteria of this study will be included. Eleven students who have not fullfilled this criteria the inclusion criteria will be excluded from the study. Power analysis has been performed and the required sample volume for each group has been calculated as 34 with 0,90 power and 0.05 margin of error. Sample of the study consistsof 75 students considering the possibility of students leaving the research. This 75 students will be divided into two groups as intervention group (n=38) and control group (n=37). Intervention and control group have been randomly selected among Ankara University Faculty of Health Sciences Nursing Department.

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Altindag
      • Ankara, Altindag, Turkey, 06340
        • Ankara University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ankara University Faculty of Health Sciences Department of Nursing to be a 1st year student.

Exclusion Criteria:

  • Diabetes mellitus
  • Hypertension
  • Hypothyroidism
  • Hyperaldosteronism
  • Pregnancy
  • Malignancy
  • Congestive heart failure
  • Psychotic disorder
  • Chronic hepatic failure
  • Nephrotic syndrome
  • Chronic renal failure diagnosis
  • Using medical drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
No intervention
Experimental: Intervention
Laughter yoga group
Behavioral: Laughter yoga
440/5000 Laughter yoga; It is an exercise program that combines breathing techniques with unconditional laughter. During the sessions, laughter is simulated by hand clapping and warm-up exercises and by eye contact with other members in the group and by playing childish games with group members. Most of the time this simulation turns into genuine and contagious laughter. Laughter yoga is based on the argument that the brain cannot distinguish between real and unreal laugh.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of mental symptoms
Time Frame: Four weeks
Data Collection Form is Brief Symptom Inventory(BSI). There are 5 sub-dimensions and 53 items in total.BSI has 5 sub-dimensions: Anxiety, Hostility, Somatization, Depression, Anxiety. The total score for each subscale is divided by the number of items in that sub-scale. The height of the total scores taken from the scale indicates the frequency of the individual's symptoms. The person answering the scale marks one of the following for each question: (0) None; (1) Very little; (2) "Moderate; (3) quite a lot; (4) Too much Application process consist of three phases such as; pre-test, intervention and post-test. During pre-test phase. Whether there is a significant decrease in posttest scores compared to pre-test mean scores.
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of saliva cortisol
Time Frame: Each session for four weeks
Saliva samples for the study of salivary cortisol level. Saliva samples have been taken from intervention and control group students for measurement of salivary cortisol level at 07.55 am before each session. During the intervention phase; laughter yoga has been applied to the intervention group after the pre-test. There hasn't been any intervention for the control group during the research.Saliva samples have been taken from the students who have participated in the study at 08.40 am for each cortisol level measurement after each session. According to the Preliminary Test, it will be evaluated whether there is a significant decrease in the final test scores.
Each session for four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara University

Investigators

  • Study Director: Ayfer Tezel, Prof. Dr., Ankara Uviversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2017

Primary Completion (Actual)

December 5, 2017

Study Completion (Actual)

December 20, 2017

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

January 21, 2019

First Posted (Actual)

January 24, 2019

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LYMSSC26102018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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