NCT05681013

Brief Summary

The aim of this study is to determine the effect of laughter therapy on the general health status, sleep quality, and stress level of nursing students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 11, 2023

Completed
Last Updated

January 11, 2023

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

December 11, 2022

Last Update Submit

December 27, 2022

Conditions

Keywords

Sleep QualityPsychological StressGeneral HealthNursing StudentsLaughter Therapy

Outcome Measures

Primary Outcomes (4)

  • Introductory Information Form

    It was prepared by the researchers in line with the literature in order to collect data about the individual characteristics of the participants. Form; family structure, gender, income status, marital status, health status, age, etc. It consists of 13 items (pretest-posttest design was applied).

    2 minutes

  • General Health Questionnaire-28 (GHQ-28)

    It was prepared to detect mental health problems. Individuals who score below 5 on the scale are evaluated as "normal", while individuals who score 5 and above are considered as a "risk group" in terms of mental health (pretest-posttest design was applied).

    5 minutes

  • Pittsburgh Sleep Quality Index (PUKI)

    "Poor sleep quality" is expressed for individuals who score 5 and above from the scale. The scale consists of 24 items that evaluate sleep quality and disorders by scoring over a one-month period (pretest-posttest design was applied).

    5 minutes

  • Perceived Stress Scale (PSS)

    The scale, which was prepared to evaluate the perceived stress level of the individual, consists of 14 items. High scores obtained from the scale indicate that the person has a high perception of stress(pretest-posttest design was applied).

    3 minutes

Study Arms (2)

Laughter Therapy Group

EXPERIMENTAL

A pre-test was administered to all students. In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index and Perceived Stress Scale were applied. Experimental and control groups were formed randomly among the students who filled all the scales. Communication groups were established for the students in both groups without being told which group they belonged to. Considering the hours suitable for the experimental group, 8 sessions of laughter therapy were applied for an average of 45 minutes. At the end of the therapy in the last session, a post-test was administered to all of the students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied.

Behavioral: Laughter Therapy

Control Group

NO INTERVENTION

In the pre-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied. At the end of the therapy in the last session, a post-test was administered to all students. In the post-test application, the Descriptive Information Form, General Health Questionnaire-28, Pittsburgh Sleep Quality Index, and Perceived Stress Scale were applied.

Interventions

The effect of the Laughter Therapy on nursing students

Laughter Therapy Group

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Volunteering to participate in research
  • Being a 1st or 2nd-year student in the Faculty of Health Sciences, Department of Nursing
  • Not have any health problems that may create a communication barrier
  • Being in a quiet environment to participate in the online study due to the pandemic period
  • Have an internet connection to attend online sessions

You may not qualify if:

  • Having undergone abdominal surgery in the past three months
  • Having a disability to attend regular sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Sıtkı Koçman University

Muğla, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress, PsychologicalSleep Initiation and Maintenance DisordersSleep Wake DisordersMental Disorders

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Elif Uner, Dr

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 11, 2022

First Posted

January 11, 2023

Study Start

February 1, 2021

Primary Completion

May 30, 2021

Study Completion

June 17, 2022

Last Updated

January 11, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations