NCT04786483

Brief Summary

This study was designed as a randomized controlled, pre-test-post-test control group in order to determine the effect of laughter therapy on anxiety, life satisfaction and psychological well-being of nursing students. Laughter therapy was applied to the experimental group for at least 60 minutes, 10 sessions two days a week. For the evaluation, the state-continuity anxiety scale, life satisfaction scale, psychological well-being scale were applied at the pre-application stage (pre-test) and after the laughter therapy sessions (post-test). The following hypotheses were included in this study; H1: Laughter therapy given during the Covid19 pandemic reduces the anxiety level of intern students. H2: Laughter therapy given during the Covid19 pandemic affects the life satisfaction of intern students. H3: During the Covid19 pandemic process, the laughter therapy given to interns affects the relationship between anxiety levels and life satisfaction. H4: Laughter therapy given to intern students during the Covid19 pandemic process affects psychological well-being.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2020

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

Study Start

First participant enrolled

November 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

February 24, 2021

Last Update Submit

March 5, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • psychological well-being

    What are the anxiety levels of the students after the laughter therapy given during the Covid19 pandemic? State and trait anxiety scales will be used to measure students' anxiety levels before and after laughter therapy. The scale is a Likert-type scale that separately measures state-continuity anxiety levels with 20 questions. The scale consists of twenty-item state anxiety and trait anxiety scales, with high scores showing high levels of anxiety, and low scores showing low levels of anxiety. The total score obtained from both scales varies between 20-80. Big score indicates high anxiety level, small score indicates low anxiety level. It is a four-degree scale ranging from "None" to "Totally".

    4 months

  • life satisfaction

    What is the life satisfaction of the students after the laughter therapy given during the Covid19 pandemic? The life satisfaction levels of the students before and after the laughter therapy will be measured using the 'life satisfaction scale'. The scale consists of five positive statements. The scale, which aims to measure general life satisfaction, is suitable for all ages, from adolescents to adults. The scale has a 7-point Likert type evaluation. Level of participation in scale items "1 = Not at all appropriate", "2 = Not suitable", "3 = Somewhat unsuitable", "4 = Neither suitable nor not appropriate", "5 = Somewhat appropriate", "6 = Not suitable", It is scored as "7 = Very suitable". A minimum of 5 and a maximum of 35 points can be obtained from scale items. A low score on the scale is accepted as an indicator of low life satisfaction.

    4 months

  • Psychological Well-being

    What are the psychological well-being levels of the students after the laughter therapy given during the Covid19 pandemic? Psychological well-being scale will be used to evaluate students' psychological well-being before and after laughter therapy. Psychological well-being scale consists of eight items. The scale is scored between 1-7. The high score to be obtained from the scale indicates that the person has psychological power.

    4 months

Study Arms (2)

Laughter Therapy group

EXPERIMENTAL

All students enrolled in the laughter therapy group will receive a total of 10 sessions of laughter therapy, 60 minutes, 2 days a week.

Other: Laughter Theraphy

Control

NO INTERVENTION

No attempt will be made to students in this group.

Interventions

Laughter therapy will be applied for 60 minutes, 10 sessions, 2 days a week. The therapy, which starts with the stimulation of the acupuncture points in the palm and acquaintance with hand clapping for an average of 10 minutes, continues with deep breathing and breathing exercises that include diaphragmatic breathing. The childish games section, which is played to reveal and trigger simulated laughter, is the section where laughter starts as "if" and turns into reality. The last part is the part where the group makes eye contact for no reason and for no reason, and laughs for at least 3 minutes unconditionally. In the last part, wish meditation and relaxation sessions are performed.

Also known as: Alternative
Laughter Therapy group

Eligibility Criteria

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

You may qualify if:

  • A student of the Faculty of Health Sciences, Department of Nursing and enrolled in the fall semester,
  • Who has not studied laughter yoga before or did not do laughter yoga,
  • It will create students who agree to participate in the research.

You may not qualify if:

  • Being a foreign national,
  • Having a situation where laughter yoga is not recommended (having surgery in the abdominal region in the last three months, uncontrolled hypertension, chronic cough, incontinence, acute back pain, acute mental disorders, consumption of antipsychotic drugs, glaucoma, hernia, epilepsy),
  • Students with simultaneous participation in any complementary treatment methods will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zonguldak Bülent Ecevit University

Zonguldak, Turkey (Türkiye)

Location

Related Publications (3)

  • Morishima T, Miyashiro I, Inoue N, Kitasaka M, Akazawa T, Higeno A, Idota A, Sato A, Ohira T, Sakon M, Matsuura N. Effects of laughter therapy on quality of life in patients with cancer: An open-label, randomized controlled trial. PLoS One. 2019 Jun 27;14(6):e0219065. doi: 10.1371/journal.pone.0219065. eCollection 2019.

    PMID: 31247017BACKGROUND
  • Kuru Alici N, Zorba Bahceli P, Emiroglu ON. The preliminary effects of laughter therapy on loneliness and death anxiety among older adults living in nursing homes: A nonrandomised pilot study. Int J Older People Nurs. 2018 Dec;13(4):e12206. doi: 10.1111/opn.12206. Epub 2018 Jul 13.

    PMID: 30004172BACKGROUND
  • Sahu P. Closure of Universities Due to Coronavirus Disease 2019 (COVID-19): Impact on Education and Mental Health of Students and Academic Staff. Cureus. 2020 Apr 4;12(4):e7541. doi: 10.7759/cureus.7541.

MeSH Terms

Conditions

Anxiety DisordersPersonal SatisfactionPsychological Well-BeingCOVID-19

Interventions

Mutation

Condition Hierarchy (Ancestors)

Mental DisordersBehaviorPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Genetic VariationGenetic Phenomena

Study Officials

  • Şule Ecevit Alpar, Doctorate

    Üniversite

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 24, 2021

First Posted

March 8, 2021

Study Start

November 1, 2020

Primary Completion

January 30, 2021

Study Completion

May 10, 2021

Last Updated

March 8, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations