LaughterNCT05193955
The Effect of Laughter Yoga Practiced Before Simulation Training
A study testing Laughter Yoga in people with Laughter and State Anxiety, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laughter, State Anxiety, Stress
- What is being tested?
- Laughter Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over,
- Students who voluntarily agree to participate in the research will be included in the research.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Laughter, State Anxiety, Stress, Self Confidence, Satisfaction, Personal
- Being tested
- Laughter Yoga
- Medical subject headings
- Laughter, Anxiety Disorders, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | undergraduate students who practice laughter yoga and simulation education together Receives: Other: Laughter Yoga |
| Control Group | No intervention | undergraduate students who practice simulation education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Jan 2022
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaughterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe ARIKAN DÖNMEZ, Hacettepe University
- Investigators
- Ayşe ARIKAN DÖNMEZ, PhD, Principal investigator, Hacettepe University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193955
- Sponsor's protocol ID
- KA-20027
- Status last verified
- Apr 2023
- First submitted
- 26 Nov 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga Practiced Before Simulation Training on State Anxiety, Student Satisfaction and Perceived Stress Level of Undergraduate Nursing Students
- ClinicalTrials.gov ID
- NCT05193955
- Acronym / sponsor ID
- KA-20027
- Conditions
- Laughter, State Anxiety, Stress, Self Confidence, Satisfaction, Personal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Laughter Yogaundergraduate students who practice laughter yoga and simulation education together |
| Control Group | No intervention | –undergraduate students who practice simulation education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and over,
- Students who voluntarily agree to participate in the research will be included in the research.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laughter YogaLaughter 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. | Other | Intervention Group |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşe ARIKAN DÖNMEZ, PhD principal investigator
Hacettepe University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laughter Yoga in people with Laughter and State Anxiety, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.