NCT03814265

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 14, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 5, 2017

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

21 days

First QC Date

November 22, 2018

Last Update Submit

January 21, 2019

Conditions

Keywords

CortisolLaughter YogaMental SymptomNursingStudent

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Measurement of saliva cortisol

    Each session for four weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Laughter yoga group

Behavioral: Laughter yoga

Control

NO INTERVENTION

No intervention

Interventions

Laughter yogaBEHAVIORAL

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.

Intervention

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University

Ankara, Altindag, 06340, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Ayfer Tezel, Prof. Dr.

    Ankara Uviversity

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Fatma Ozlem Ozturk

Study Record Dates

First Submitted

November 22, 2018

First Posted

January 24, 2019

Study Start

November 14, 2017

Primary Completion

December 5, 2017

Study Completion

December 20, 2017

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations