NCT05806541

Brief Summary

Brief Summary: Laughter is an innate, universal response we give to events in our lives. "Laughter Therapy" is a technique created by combining breathing techniques and laughter and takes its place in complementary medicine. It is a simulation performed by making eye contact with the members of the group, in which physical exercise and childlike games take place. Laughter sessions are about 30-40 minutes. continues and this simulation in a short time creates a real and contagious laugh. It has been determined by studies that laughter therapy physiologically increases breathing and relaxes muscles, strengthens mental function by decreasing the level of stress hormones, reduces burnout, depression and anxiety levels, positively affects quality of life, increases social interaction and provides psychological well-being. Self-efficacy, on the other hand, is a state that expresses a person's belief that he or she is able to perform a certain task. More broadly, self-efficacy examines an individual's ability to perform a task rather than individual characteristics such as physical or psychological characteristics. Psychological well-being is as important as self-efficacy in the development of students. In addition, studies on mental health have generally focused on anxiety and depression. Most of these studies were related to well-being and contributed to the literature. Psychological well-being is defined as managing existential challenges in life. Aim: This study was planned to determine the Effect of Laughter Therapy on Self-Efficacy and Psychological Well-Being in Nursing Students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

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

First Submitted

Initial submission to the registry

March 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 10, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

November 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2024

Completed
Last Updated

April 1, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 28, 2023

Last Update Submit

March 29, 2024

Conditions

Keywords

laughter therapyself efficacynursing studentwell being

Outcome Measures

Primary Outcomes (1)

  • Introductory Information Form

    This form consists of questions such as age, gender, distraction, loss of interest in lessons, eating problems, sleep status, stress, anxiety, fear, social media use.

    one day

Secondary Outcomes (1)

  • Academic Self-Efficacy Scale

    one day

Other Outcomes (1)

  • Psychological Well-Being Scale

    one day

Study Arms (2)

control group

NO INTERVENTION

At the beginning of the study, data collection tools Personal Information Form, Academic Self-Efficacy Scale and Psychological Well-Being Scale will be applied to the control group. No intervention will be made in the control group. Measurement tools will be applied for the post-test.

experimental group

EXPERIMENTAL

Arm: Experimental: experimental group Personal Information Form, Academic Self-Efficacy Scale and Psychological Well-Being Scale will be applied to all 4th year nursing students studying at Sinop University Health Sciences in the autumn term of 2023-2024. Laughter therapy session will be applied face to face for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. Psychological Well-Being Scale and Academic Self-Efficacy Scale will be applied again after the application and in the follow-up (after the application is over).

Behavioral: laughter therapy

Interventions

Laughter therapy session will be applied online for 25-30 minutes once a week for 2 months by the researcher who has the Laughter therapy certificate to the application group. In the laughter therapy session, the practices of introducing the practitioner and introducing the therapy, breathing exercises for a healthy life, keeping the rhythm accompanied by music, turning the laughter that started as if it were childlike games into reality will be carried out.

experimental group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Study as a nursing student at the Faculty of Health Sciences where the study will be conducted,
  • Being a nursing first class student,
  • Volunteering to participate in the study.
  • Absence of any psychological disorder

You may not qualify if:

  • Not to study as a nursing student at the Faculty of Health Sciences where the study will be conducted,
  • Not to volunteer to participate in the study.
  • Have any psychological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop University

Sinop, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Laughter

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Yasemin Özyer, PhD

    Sinop University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2023

First Posted

April 10, 2023

Study Start

November 5, 2023

Primary Completion

January 5, 2024

Study Completion

January 8, 2024

Last Updated

April 1, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations