Laughter YogaNCT05942131
The Effect of Group-Based Laughter Yoga on Midwifery Students
A study testing Group-based laughter yoga in people with Laughter Yoga, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of laughter yoga on the secondary traumatic stress and depression levels experienced by midwifery students due to the use of social media after the earthquake. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga
- What is being tested?
- Group-based laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Aug 2024
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being an active student in the 3rd year of Health Sciences University, Hamidiye Faculty of Health Sciences, Department of Midwifery
- Volunteering to participate in research
Who cannot join
- Having a psychiatric diagnosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences
Istanbul, Uskudar
Yasemin Aydın Kartal Assoc. Prof. Dr., +90 543 287 00 29, yasemin.aydin@sbu.edu.tr
Aleyna Bulut Research Assistant, +90 536 562 61 84, aleyna.bulut@sbu.edu.tr
About this study
Official title: The Effect of Group-Based Laughter Yoga on the Level of Secondary Traumatic Stress and Depression Experienced by Midwifery Students After the Earthquake
This study was planned to determine the effect of laughter yoga on the secondary traumatic stress and depression levels experienced by midwifery students due to the use of social media after the earthquake. The universe of the research will be the third year students of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department (N:84).
A total of 8 sessions of laughter yoga, 2 sessions per week, will be applied to midwifery students in the intervention group of the research. It will be determined as intervention (n:42) and control (n:42) groups. "Descriptive Information Form", "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" will be applied to both groups.
Read the detailed description
It was planned to determine the effect of laughter yoga on the secondary traumatic stress and depression levels experienced by midwifery students due to the use of social media after the earthquake. The study will be implemented according to the CONSORT 2010 guidelines.
The research will be carried out in Health Sciences University, Hamidiye Faculty of Health Sciences, Midwifery department classroom. In pre-research classrooms; An environment with good lighting, sound systems and allowing individuals to move comfortably will be arranged. Hamidiye Faculty of Health Sciences Midwifery Department 3rd year students who volunteered to participate in the study will be determined as the intervention (n:42) and control (n:42) groups with the numbers assigned by the researchers via the https://www.randomizer.org/ site. An introductory information form will be applied to all students. A total of 8 sessions of laughter yoga, 2 sessions per week, will be applied to midwifery students in the intervention group of the research. Laughter yoga will be practiced by researchers with leadership certification. Each session will take an average of 45 minutes. Each session will consist of groups of 7 people. Before starting the laughter yoga session, an information meeting will be held with midwifery students who volunteered to participate in the study and were assigned to the intervention group. Midwifery students will be administered "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" before and 4-6 weeks after the application. No intervention will be applied to the control group midwives, and "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" will be administered again when they are included in the study and 4-6 weeks later.
- Conditions
- Laughter Yoga
- Being tested
- Group-based laughter yoga
- Keywords
- secondary trauma, depression, midwifery student, earthquake
- Medical subject headings
- Compassion Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-based laughter yogaOther
A total of 8 sessions of laughter yoga will be applied to the students in the intervention group, 2 sessions per week. Each session will last 45 minutes on average. Each session will consist of groups of 7 people. An information meeting about the sessions will be held with the midwifery students who volunteered to participate in the study and assigned to the intervention group before starting laughter yoga. Midwifery students will be administered "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" before and after 4-6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (n:42) | Experimental | Laughter yoga will be practiced to students in the intervention group Receives: Other: Group-based laughter yoga |
| Control Group (n:42) | No intervention | No intervention will be applied to the control group midwives and "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" will be applied when they are included in the study and again after 4-6 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory Information Form
In this form, which was created by the researchers based on the literature, participants' age, high school they graduated from, secondary traumatic stress experience, etc. questions are included.
Measured: 1 hour before laughter yoga practice
Beck Depression Inventory (BDI)
The scale designed to determine the depressive levels of individuals consists of 21 items. The aim of the inventory is not to diagnose depression but to express the degree of depressive symptoms numerically. Higher scores indicate an increase in depressive symptoms. Each item receives a score between 0-3 and the scores that can be obtained from the inventory are between 0-63. The scores of 0-9 points indicate normal, 10-18 points indicate mild, 19-29 points indicate moderate, and 30-63 points indicate severe depressive symptoms.
Measured: 1 hour before laughter yoga practice
Secondary Traumatic Stress Scale for Social Media Users
The scale was developed to examine avoidance and arousal symptoms associated with indirect exposure to traumatic experiences through social media users. The scale consists of 17 items. The scale was reduced to a single-factor structure. There are no reverse coded items. The lowest score that can be obtained from the scale is 17 and the highest score is 85. As the total score obtained from the scale increases, individuals' secondary traumatic stress caused by social media increases.
Measured: 1 hour before laughter yoga practice
Secondary outcomes (2)
Beck Depression Inventory (BDI)
The scale designed to determine the depressive levels of individuals consists of 21 items. The aim of the inventory is not to diagnose depression but to express the degree of depressive symptoms numerically. Higher scores indicate an increase in depressive symptoms. Each item receives a score between 0-3 and the scores that can be obtained from the inventory are between 0-63. The scores of 0-9 points indicate normal, 10-18 points indicate mild, 19-29 points indicate moderate, and 30-63 points indicate severe depressive symptoms.
Measured: 4-6 weeks after application
Secondary Traumatic Stress Scale for Social Media Users
The scale was developed to examine avoidance and arousal symptoms associated with indirect exposure to traumatic experiences through social media users. The scale consists of 17 items. The scale was reduced to a single-factor structure. There are no reverse coded items. The lowest score that can be obtained from the scale is 17 and the highest score is 85. As the total score obtained from the scale increases, individuals' secondary traumatic stress caused by social media increases.
Measured: 4-6 weeks after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laughter YogaStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Model description
- Single blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YASEMİN AYDIN KARTAL, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942131
- Sponsor's protocol ID
- SBÜ-AYDINKARTAL-005
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2023
- Last updated
- 12 Jul 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 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Group-Based Laughter Yoga on the Level of Secondary Traumatic Stress and Depression Experienced by Midwifery Students After the Earthquake
- ClinicalTrials.gov ID
- NCT05942131
- Acronym / sponsor ID
- SBÜ-AYDINKARTAL-005
- Conditions
- Laughter Yoga
- Keywords
- secondary trauma, depression, midwifery student, earthquake
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 12 Jul 2023 (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.
This study was planned to determine the effect of laughter yoga on the secondary traumatic stress and depression levels experienced by midwifery students due to the use of social media after the earthquake. The universe of the research will be the third year students of Health Sciences University Hamidiye Health Sciences Faculty Midwifery Department (N:84).
A total of 8 sessions of laughter yoga, 2 sessions per week, will be applied to midwifery students in the intervention group of the research. It will be determined as intervention (n:42) and control (n:42) groups. "Descriptive Information Form", "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" will be applied to both groups.
Detailed description
It was planned to determine the effect of laughter yoga on the secondary traumatic stress and depression levels experienced by midwifery students due to the use of social media after the earthquake. The study will be implemented according to the CONSORT 2010 guidelines.
The research will be carried out in Health Sciences University, Hamidiye Faculty of Health Sciences, Midwifery department classroom. In pre-research classrooms; An environment with good lighting, sound systems and allowing individuals to move comfortably will be arranged. Hamidiye Faculty of Health Sciences Midwifery Department 3rd year students who volunteered to participate in the study will be determined as the intervention (n:42) and control (n:42) groups with the numbers assigned by the researchers via the https://www.randomizer.org/ site. An introductory information form will be applied to all students. A total of 8 sessions of laughter yoga, 2 sessions per week, will be applied to midwifery students in the intervention group of the research. Laughter yoga will be practiced by researchers with leadership certification. Each session will take an average of 45 minutes. Each session will consist of groups of 7 people. Before starting the laughter yoga session, an information meeting will be held with midwifery students who volunteered to participate in the study and were assigned to the intervention group. Midwifery students will be administered "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" before and 4-6 weeks after the application. No intervention will be applied to the control group midwives, and "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" will be administered again when they are included in the study and 4-6 weeks later.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (n:42) | Experimental | Other: Group-based laughter yogaLaughter yoga will be practiced to students in the intervention group |
| Control Group (n:42) | No intervention | –No intervention will be applied to the control group midwives and "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" will be applied when they are included in the study and again after 4-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being an active student in the 3rd year of Health Sciences University, Hamidiye Faculty of Health Sciences, Department of Midwifery
- Volunteering to participate in research
Key exclusion criteria (1 listed)
- Having a psychiatric diagnosis
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 |
|---|---|---|
| Group-based laughter yogaA total of 8 sessions of laughter yoga will be applied to the students in the intervention group, 2 sessions per week. Each session will last 45 minutes on average. Each session will consist of groups of 7 people. An information meeting about the sessions will be held with the midwifery students who volunteered to participate in the study and assigned to the intervention group before starting laughter yoga. Midwifery students will be administered "Secondary Traumatic Stress Scale for Social Media Users" and "Beck Depression Inventory" before and after 4-6 weeks. | Other | Intervention Group (n:42) |
Primary outcome
Introductory Information Form
Time frame: 1 hour before laughter yoga practice
In this form, which was created by the researchers based on the literature, participants' age, high school they graduated from, secondary traumatic stress experience, etc. questions are included.
Beck Depression Inventory (BDI)
Time frame: 1 hour before laughter yoga practice
The scale designed to determine the depressive levels of individuals consists of 21 items. The aim of the inventory is not to diagnose depression but to express the degree of depressive symptoms numerically. Higher scores indicate an increase in depressive symptoms. Each item receives a score between 0-3 and the scores that can be obtained from the inventory are between 0-63. The scores of 0-9 points indicate normal, 10-18 points indicate mild, 19-29 points indicate moderate, and 30-63 points indicate severe depressive symptoms.
Secondary Traumatic Stress Scale for Social Media Users
Time frame: 1 hour before laughter yoga practice
The scale was developed to examine avoidance and arousal symptoms associated with indirect exposure to traumatic experiences through social media users. The scale consists of 17 items. The scale was reduced to a single-factor structure. There are no reverse coded items. The lowest score that can be obtained from the scale is 17 and the highest score is 85. As the total score obtained from the scale increases, individuals' secondary traumatic stress caused by social media increases.
2 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: 4-6 weeks after application
Secondary Traumatic Stress Scale for Social Media Users
Time frame: 4-6 weeks after application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Laughter Yoga
Not yet recruiting
The Effect of Laughter Yoga on Individual and Organizational Outcomes in Nurse Managers
Burnout, Professional, Stress, Psychological
Not yet recruiting
Laughter Yoga- Integrated Virtual Reality Nature Exploration in Early Stage of Chemotherapy
Patiens in Early Stage of Chemotherapy
Enrolling by invitation
Effects of Laughter Yoga in the Third Trimester
Pregnancy, Psychosocial Health
Active, not recruiting
Laughter Yoga, Emotional Labor, and Menopause-Specific Quality of Life in Nurses
Menopause, Menopause-Related Quality of Life
Recruiting
Evaluation of the Effects of Laughter Yoga
Multiple Sclerosis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-based laughter yoga in people with Laughter Yoga, run by Saglik Bilimleri Universitesi 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 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasemin Aydın Kartal Assoc. Prof. Dr. (+90 543 287 00 29, yasemin.aydin@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Introductory Information Form (time frame: 1 hour before laughter yoga practice). The study lists 3 primary outcomes in all. 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 12 Jul 2023.