NCT05193955

Brief Summary

Simulation education has become one of the innovative educational approaches that are widely used in providing nursing students with knowledge, skills, and attitudes towards vocational courses. Simulation education provides students with the opportunity to combine their knowledge and skills and provide nursing care in a high-reality environment. However, the fact that simulation training is a method that requires the student to recognize a clinical event, make a clinical decision, and intervene with the patient in line with this decision may cause students to experience anxiety and affect their learning. Although there are limited studies conducted on nursing students, it is stated that new approaches such as laughter yoga are effective in reducing anxiety and stress levels. In this direction, this research; In this study, it was planned to investigate the effectiveness of laughter yoga in terms of reducing the anxiety experienced by nursing students during simulation training and increasing their learning satisfaction. The universe of the research will be the second-year students of Hacettepe University Faculty of Nursing. As a result of the power analysis, it is aimed to reach 54 people. The study was planned in a randomized controlled design. Research data will be collected through Personal Information Form, State Anxiety Scale, Student Satisfaction and Self-Confidence in Learning Scale, Perceived Stress Scale for Nursing Students, and Students' Vital Findings Evaluation Form. With this study, it is predicted that laughter yoga to be applied to nursing students before simulation training will have a positive effect on state anxiety, student satisfaction, and perceived stress level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

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

November 26, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

November 26, 2021

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • State Anxiety Scale

    Inventory is used to determine how an individual feels at a particular moment and in a situation.High scores indicate high anxiety level, low scores indicate low anxiety level. There are two types of statements in the scale, direct and reverse. Direct statements express negative emotions, reversed statements express positive emotions. Reversed statements are items 1,2,5,8,10,11,15,16,19 and 20. After finding the total weights of the direct and reversed statements separately, a predetermined and unchanging value (50) is added to the result obtained by subtracting the total weight score of the reverse statements from the total weight score obtained for the direct statements.Range of scores for each subtest is 20-80, the higher score indicating greater anxiety.

    It will be applied to the students just before simulation and/or laughter yoga and after completing the training on the same day (each session is 60 minutes). Change from baseline State Anxiety scores at the end of 60 minutes.

Secondary Outcomes (2)

  • Student Satisfaction and Self-Confidence in Learning Scale

    It will be applied immediately after completing the simulation training and/or laughter yoga on the same day (at the end of 60 minutes). Change from baseline Student Satisfaction and Self-Confidence in Learning scores at the end of 60 minutes.

  • Perceived Stress Scale for Nursing Students

    It will be applied to the students just before simulation and/or laughter yoga and after completing the training on the same day (each session is 60 minutes). Change from baseline Perceived Stress scores at the end of 60 minutes.

Study Arms (2)

Intervention Group

EXPERIMENTAL

undergraduate students who practice laughter yoga and simulation education together

Other: Laughter Yoga

Control Group

NO INTERVENTION

undergraduate students who practice simulation education

Interventions

Laughter yoga is one of the methods that is among the complementary therapy and supportive care practices in the world and is used increasingly. Laughter yoga is a non-invasive and non-pharmacological method that combines unconditional laughter with yoga breathing techniques. In laughter yoga, one can laugh without being humorous, joking, or funny. Laughter is simulated by starting out as a physical exercise and making eye contact with other members of the group and playing games with them. The body cannot distinguish between real and unreal laughter and laughter begins.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • years and over,
  • Students who voluntarily agree to participate in the research will be included in the research.

You may not qualify if:

  • Taking any medication that affects the heart rate,
  • Having any psychiatric disease such as anxiety disorder,
  • Students who do not accept to participate in the research will not be included in the research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

LaughterAnxiety DisordersPersonal Satisfaction

Interventions

Laughter Therapy

Condition Hierarchy (Ancestors)

Nonverbal CommunicationCommunicationBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Ayşe ARIKAN DÖNMEZ, PhD

    Hacettepe University Faculty of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

November 26, 2021

First Posted

January 18, 2022

Study Start

January 1, 2022

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations