The Effect of Laughter Yoga Practiced Before Simulation Training

April 26, 2023 updated by: Ayşe ARIKAN DÖNMEZ, Hacettepe University

The Effect of Laughter Yoga Practiced Before Simulation Training on State Anxiety, Student Satisfaction and Perceived Stress Level of Undergraduate Nursing Students

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study will be carried out in a randomized controlled design with the aim of determining the effect of laughter yoga applied before the simulation training on the state anxiety, student satisfaction, and perceived stress level of nursing students. After the power analysis to calculate the sample size of the study, a total of 36 students will be included in each group with 90% power and 5% margin of error for multiple variance analysis in repeated measurements in a 2x2 factorial pattern between groups. In the research, students who have applied laughter yoga and simulation application together will form the intervention group, and students who only participated in the simulation application will form the control group.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
undergraduate students who practice laughter yoga and simulation education together
Other: Laughter Yoga
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.
No Intervention: Control Group
undergraduate students who practice simulation education

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
State Anxiety Scale
Time Frame: 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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Student Satisfaction and Self-Confidence in Learning Scale
Time Frame: 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.
This scale, which is widely used to evaluate students' attitudes and beliefs about simulation, was published by the National League for Nurses. The Turkish validity-reliability study of the scale was carried out by Karaçay and Kaya in 2017. Accordingly, the Cronbach's Alpha coefficient of the scale was found to be 0.88. There are two sub-dimensions, "satisfaction with learning" and "self-confidence", and a total of 13 items in the scale. The highest total score that can be obtained from the scale is 65, and the lowest is 13.The high score that can be obtained from the total of the scale indicates high satisfaction and self-confidence.
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
Time Frame: 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.
The Perceived Stress Scale for Nursing Students (PSASS), a 29-item scale originally in Chinese, was developed by Sheu et al. It was developed by (2002) . The Turkish validity-reliability study of the scale was performed by Karaca et al. (2015) made by Accordingly, the Cronbach's Alpha coefficient of the scale was found to be 0.85. The total score that can be obtained from the scale ranges from 0 to 116. As the score obtained from the scale increases; perceived stress level also increases.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hacettepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ayşe ARIKAN DÖNMEZ, PhD, Hacettepe University Faculty of Nursing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KA-20027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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