Laughter YogaNCT05831280
The Effect of Laughter Yoga on the Stress Levels of Infertility Women
A study testing Laughter Yoga in people with Laughter Yoga, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. Randomization was provided in the sample included in the study, and it was divided into experimental and control groups. Read more about this study
- Who is it for?
- Ages 19 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Laughter Yoga
- What is being tested?
- Laughter Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2022to 30 Jun 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 19 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- be between the ages of 19-45
- have been diagnosed with infertility
- At least primary school graduate
- Not having a diagnosed psychiatric disease
- Will not have an ovulation pick up process, Intrauterine insemination and Embryo transfer procedure in the next 1 month
Who cannot join
- Have ovulation pick up process in the last 1 month
- undergoing Intrauterine insemination in the last 1 month
- undergoing an Embryo transfer in the last 1 month
- Not regularly attending laughter yoga sessions (for the experimental group)
- Applying another alternative method to reduce stress during the research process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Laughter Yoga on the Stress Levels of Infertility Women: A Randomized Controlled Trial
This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. Randomization was provided in the sample included in the study, and it was divided into experimental and control groups. At the beginning of the study, the Infertility Stress Scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks. No application was made to the control group. After 4 weeks, the Infertility Stress Scale was administered to the women in both groups to re-determine their stress levels.
Read the detailed description
This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. At the beginning of the study, necessary ethics committee permission and institutional permissions were obtained. Both of the researchers have a certificate of leadership in laughter yoga. As a result of the power analysis, it was determined that 80 women should be included in the study. Considering that there may be losses, it was decided to include 90 women in the study. By providing randomization, 90 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 45 experimental and 45 control. At the beginning of the study, the Infertility stress scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks, two sessions a week. No application was made to the control group. After 4 weeks, the Infertility stress scale was administered to the women in both groups to re-determine their stress levels.
- Conditions
- Laughter Yoga
- Being tested
- Laughter Yoga
- Keywords
- Laughter Yoga, Infertility, Stress, Nurse
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter YogaBehavioural
- Warm-up exercises (5 minutes),
- Deep breathing exercises (5 minutes),
- Childlike playfulness (5 minutes),
- Laughter exercises (15 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Experimantal Group | Experimental | In the study, 8 sessions of laughter yoga will be applied to the women in the experimental group twice a week for 4 weeks. Receives: Behavioral: Laughter Yoga |
| Control Group | No intervention | no intervention will be applied to the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress levels of women
The difference between the infertility stress scale pretest and posttest mean scores of women in both groups. Higher scores indicate increased stress.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start10 Sep 2022
- Primary completion10 Feb 2023
- Study completion30 Jun 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 Ataturk UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı SİS ÇELİK, Ataturk University
- Investigators
- Aslı SİS ÇELİK, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831280
- Sponsor's protocol ID
- aslı14
- Status last verified
- Jul 2023
- First submitted
- 14 Apr 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on the Stress Levels of Infertility Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05831280
- Acronym / sponsor ID
- aslı14
- Conditions
- Laughter Yoga
- Keywords
- Laughter Yoga, Infertility, Stress, Nurse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Apr 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 research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. Randomization was provided in the sample included in the study, and it was divided into experimental and control groups. At the beginning of the study, the Infertility Stress Scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks. No application was made to the control group. After 4 weeks, the Infertility Stress Scale was administered to the women in both groups to re-determine their stress levels.
Detailed description
This research is a randomized controlled study to evaluate the effect of Laughter yoga on the stress levels of infertility women. At the beginning of the study, necessary ethics committee permission and institutional permissions were obtained. Both of the researchers have a certificate of leadership in laughter yoga. As a result of the power analysis, it was determined that 80 women should be included in the study. Considering that there may be losses, it was decided to include 90 women in the study. By providing randomization, 90 women who met the sampling criteria and volunteered to participate in the study were divided into two groups as 45 experimental and 45 control. At the beginning of the study, the Infertility stress scale was applied to women in both groups to determine their stress levels. Afterwards, 8 sessions of laughter yoga were applied to the experimental group for 4 weeks, two sessions a week. No application was made to the control group. After 4 weeks, the Infertility stress scale was administered to the women in both groups to re-determine their stress levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Experimantal Group | Experimental | Behavioral: Laughter YogaIn the study, 8 sessions of laughter yoga will be applied to the women in the experimental group twice a week for 4 weeks. |
| Control Group | No intervention | –no intervention will be applied to the control group |
Who may qualify
- Ages
- 19 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- be between the ages of 19-45
- have been diagnosed with infertility
- At least primary school graduate
- Not having a diagnosed psychiatric disease
- Will not have an ovulation pick up process, Intrauterine insemination and Embryo transfer procedure in the next 1 month
Key exclusion criteria (5 listed)
- Have ovulation pick up process in the last 1 month
- undergoing Intrauterine insemination in the last 1 month
- undergoing an Embryo transfer in the last 1 month
- Not regularly attending laughter yoga sessions (for the experimental group)
- Applying another alternative method to reduce stress during the research process
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 Yoga* Warm-up exercises (5 minutes), * Deep breathing exercises (5 minutes), * Childlike playfulness (5 minutes), * Laughter exercises (15 minutes). | Behavioural | Experimantal Group |
Primary outcome
Stress levels of women
Time frame: 1 month
The difference between the infertility stress scale pretest and posttest mean scores of women in both groups. Higher scores indicate increased stress.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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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.
Aslı SİS ÇELİK study director
Ataturk University
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 Yoga, run by Ataturk 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 5 inclusion and 5 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 20 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?
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?
Stress levels of women (time frame: 1 month). 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 20 Jul 2023.