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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03814265
Other study ID # LYMSSC26102018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 14, 2017
Est. completion date December 20, 2017

Study information

Verified date January 2019
Source Ankara University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date December 20, 2017
Est. primary completion date December 5, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 25 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Turkey Ankara University Ankara Altindag

Sponsors (1)

Lead Sponsor Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Measurement of mental symptoms 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 Measurement of saliva cortisol 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
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