NCT05358197

Brief Summary

In this study, the effect of laughter yoga on sleep quality and happiness level in individuals with sleep problems will be investigated. Yoga exercises will be done for about 30 minutes with a laughter yoga instructor 3 days a week for a month.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 28, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

May 3, 2022

Status Verified

April 1, 2022

Enrollment Period

14 days

First QC Date

April 28, 2022

Last Update Submit

April 28, 2022

Conditions

Keywords

sleep quality,laughter yoga,happiness,

Outcome Measures

Primary Outcomes (4)

  • Laughter yoga improves sleep quality

    The PSQI allows evaluating the quality and disturbances of sleep over one month. The questionnaire consists of 19 self-assessed questions that are categorized into 7 components: 1) sleep quality, 2) sleep latency, 3) sleep duration, 4) sleep efficiency, 5) sleep disorders, 6) medication use to sleep, and 7) daytime sleepiness. Each component is classified in a score ranging from 0 to 3. The sum of the scores for these 7 components produces a score ranging from 0 to 21. It presents a cutoff point where it considers good sleep quality if PSQI≤5 and poor sleep quality if PSQI\>5 21

    1-15. day

  • Laughter yoga improves happiness

    "Oxford Happiness Scale Short Form OHS-F", developed by Hills and Argyle (2002) and adapted into Turkish by Dogan and Cotok (2011) was used. Oxford Happiness Scale consists of 7 expressions in one sub-dimension. The expressions on the 5-item Likert scale are answered as (1) Disagree - (5) Completely agree.

    1-15. day

  • Laughter yoga improves sleep quality

    The PSQI allows evaluating the quality and disturbances of sleep over one month. The questionnaire consists of 19 self-assessed questions that are categorized into 7 components: 1) sleep quality, 2) sleep latency, 3) sleep duration, 4) sleep efficiency, 5) sleep disorders, 6) medication use to sleep, and 7) daytime sleepiness. Each component is classified in a score ranging from 0 to 3. The sum of the scores for these 7 components produces a score ranging from 0 to 21. It presents a cutoff point where it considers good sleep quality if PSQI≤5 and poor sleep quality if PSQI\>5 21

    30. DAY

  • Laughter yoga improves happiness

    "Oxford Happiness Scale Short Form OHS-F", developed by Hills and Argyle (2002) and adapted into Turkish by Dogan and Cotok (2011) was used. Oxford Happiness Scale consists of 7 expressions in one sub-dimension. The expressions on the 5-item Likert scale are answered as (1) Disagree - (5) Completely agree.

    30. day

Study Arms (1)

Control group

EXPERIMENTAL
Other: yoga

Interventions

yogaOTHER

laughter yoga

Control group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • individuals with sleep problems individuals without mental illness

You may not qualify if:

  • those who use sleeping pills those with mental disabilities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aksaray University

Aksaray, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Yoga

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Kevser Sevgi ÜNAL ASLAN

    OSMANİYE KORKUT ATA UNİVERSİTY

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevser Sevgi ÜNAL ASLAN

CONTACT

fUNDA Çetinkaya

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nursing Department

Study Record Dates

First Submitted

April 28, 2022

First Posted

May 3, 2022

Study Start

May 1, 2022

Primary Completion

May 15, 2022

Study Completion

June 1, 2022

Last Updated

May 3, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations