AnxietyNCT06556927
The Laughter, Pregnancy, Anxiety and Llife Quality
A study testing Laughter yoga in people with Anxiety and Life Style, run by Kırklareli University at 1 site in Turkey (Türkiye).
Trial summary
Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Life Style, Gestational Diabetes
- What is being tested?
- Laughter yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2024to 15 May 2025
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteering to participate in the study
- Answering the survey and scale forms completely
- Being 18 years of age or older
- Being able to read and understand Turkish
- Not having any physical or mental problems that would prevent communication
- Pregnant women diagnosed with gestational diabetes
Show all 9Show fewer
- Being in social media accounts and WhatsApp groups
- Scoring 35 and above on the STAI scale
- Scoring 37 and above on the quality of life scale during pregnancy
Who cannot join
- Not volunteering to participate in the study
- Incomplete responses to surveys and scales
- Being under the age of 18
- Not understanding Turkish
- Having any physical or mental problems that would prevent communication
- Pregnant women who have not been diagnosed with gestational diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laughter Yoga on Stress and Quality of Life in Pregnant Women With Gestational Diabetes
Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy.
Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.
Read the detailed description
Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy.
The American College of Obstetricians and Gynecologists (ACOG) defines GDM as "abnormal glucose tolerance that begins in pregnancy or is first diagnosed during pregnancy." However, the American Diabetes Association (ADA) and the World Health Organization (WHO) want to distinguish cases with possible diabetes diagnosed before pregnancy and diagnosed during pregnancy from glucose intolerance that occurs as a result of pregnancy and is related to pregnancy. Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. Laughter yoga is a non-pharmacological and non-invasive alternative treatment method. Laughter yoga is a type of communication that combines pleasant emotions, smiles, and laughter. It is a different approach from medical treatments; indicates that the psychological aspects of the brain must change in order for both the mind and body to be healthy. Maternal complications increase in pregnant women diagnosed with gestational diabetes. The prospective psychological concerns experienced by the pregnant woman (low risk, preterm birth, low birth weight) negatively affect the quality of life of the pregnant woman. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.
- Conditions
- Anxiety, Life Style, Gestational Diabetes, Pregnancy Related
- Being tested
- Laughter yoga
- Keywords
- Pregnancy, Gestational Diabetes, Laughter yoga
- Medical subject headings
- Anxiety Disorders, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaOther
Part 1: Deep Breathing Exercises: Raise the arms up towards the sky and take a deep breath as possible and hold the breath for 4-5 seconds. This application is repeated several times. This section takes approximately 5-10 minutes.
Part 2: Warm-up exercises: Hands are kept parallel to each other and clapped. The tips of the fingers and palms touch each other, the acupuncture points on both hands are stimulated and the individual's energy level increases.
Section 3: Childish Games: In this section there are childish games. These games are visualized in the mind and the participants are asked to raise their arms upwards in the shape of the letter "Y".This section takes approximately 10 minutes.
Section 4: Laughter Exercises: Participants are given verbal guidance such as "Put your hand on your heart, feel your heartbeat, let's exhale with a smile, let's make a wish or pray" and the laughter exercise is terminated. This section takes approximately 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Laughter yoga group | Experimental | Laughter yoga will be performed in 8 sessions, 2 days a week for 4 weeks. The duration of each session will be 40 minutes. Laughter yoga sessions will be held on a day suitable for all participants and with the participation of at least 8 people. The session will start with warm-up exercises and continue with laughter exercises. People in the group will do these exercises with the guidance of the researcher. Receives: Other: Laughter yoga |
| Control group | No intervention | Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety and increase life quality. The researcher will ask the participants via phone 4 times a week for 1 month whether they have taken any action to reduce their anxiety and increase life quality symptoms. Participants who use any of the pharmacological or non-pharmacological practices to reduce anxiety and increase life quality symptoms will be excluded from the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life Scale During Pregnancy
It aims to optimally evaluate the quality of life of women with normal pregnancies and consists of nine items. It is a scale specific to singleton pregnancies that should be used in clinical and social research because it provides a better perspective on the quality of life of pregnant women rather than a general quality of life scale. The total score of the scale varies between 9-45, with higher scores indicating higher quality of life.There is no adverse substance in the scale. It can be used in every trimester
Measured: between 2 to 4 weeks
State-Trait Anxiety Inventory
The lowest and highest scores that can be obtained from each subscale are 20 and 80, respectively. Higher scores are associated with more anxiety.
Measured: between 2 to 4 weeks
Psychometric Properties of Eurohis (Whoqol-8.Tr) Turkish Version in Turkish Society
EUROHIS-QOL 8 was developed by the World Health Organization (WHO) in 2003. It consists of 8 items and was validated in Turkish by Eser et al in 2010. The total score determines the overall quality of life level; higher scores indicate higher quality of life
Measured: between 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Oct 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırklareli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Solt Kirca, Kırklareli University
- Investigators
- AYCA SOLT KIRCA, Phd, Study chair, Kırklareli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556927
- Sponsor's protocol ID
- KırklareliAS-12
- Status last verified
- Jun 2026
- First submitted
- 13 Aug 2024
- Last updated
- 18 Jun 2026
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laughter Yoga on Stress and Quality of Life in Pregnant Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT06556927
- Acronym / sponsor ID
- KırklareliAS-12
- Conditions
- Anxiety, Life Style, Gestational Diabetes, Pregnancy Related
- Keywords
- Pregnancy, Gestational Diabetes, Laughter yoga
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kırklareli UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 16 Aug 2024 (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.
Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy.
Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.
Detailed description
Gestational Diabetes is one of the most common medical complications during pregnancy. It is seen between the 24th and 28th weeks of pregnancy with the increase in insulin resistance in the second trimester and ends with the end of the birth process. Due to this feature, it is distinguished from Type 2 diabetes. This disease, which is seen for the necessary energy needs of the fetus and placenta, is defined as the diabetogenic effect of pregnancy.
The American College of Obstetricians and Gynecologists (ACOG) defines GDM as "abnormal glucose tolerance that begins in pregnancy or is first diagnosed during pregnancy." However, the American Diabetes Association (ADA) and the World Health Organization (WHO) want to distinguish cases with possible diabetes diagnosed before pregnancy and diagnosed during pregnancy from glucose intolerance that occurs as a result of pregnancy and is related to pregnancy. Laughter is a universal response to humorous stimuli that exists in our lives. Laughter yoga is holistic with breathing techniques. It is a form of yoga that utilizes the brain's inability to distinguish between real and fake laughter. Laughter yoga helps people cope with stressful times and helps the person control themselves by reducing negative cognitive reactions. Laughter yoga is a non-pharmacological and non-invasive alternative treatment method. Laughter yoga is a type of communication that combines pleasant emotions, smiles, and laughter. It is a different approach from medical treatments; indicates that the psychological aspects of the brain must change in order for both the mind and body to be healthy. Maternal complications increase in pregnant women diagnosed with gestational diabetes. The prospective psychological concerns experienced by the pregnant woman (low risk, preterm birth, low birth weight) negatively affect the quality of life of the pregnant woman. In line with this information, the aim of the study was to determine the effect of laughter yoga applied to pregnant women with gestational diabetes on perceived stress and quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter yoga group | Experimental | Other: Laughter yogaLaughter yoga will be performed in 8 sessions, 2 days a week for 4 weeks. The duration of each session will be 40 minutes. Laughter yoga sessions will be held on a day suitable for all participants and with the participation of at least 8 people. The session will start with warm-up exercises and continue with laughter exercises. People in the group will do these exercises with the guidance of the researcher. |
| Control group | No intervention | –Participants in this group will consist of people who do not routinely do any practice on their own to reduce anxiety and increase life quality. The researcher will ask the participants via phone 4 times a week for 1 month whether they have taken any action to reduce their anxiety and increase life quality symptoms. Participants who use any of the pharmacological or non-pharmacological practices to reduce anxiety and increase life quality symptoms will be excluded from the study. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Volunteering to participate in the study
- Answering the survey and scale forms completely
- Being 18 years of age or older
- Being able to read and understand Turkish
- Not having any physical or mental problems that would prevent communication
Key exclusion criteria (6 listed)
- Not volunteering to participate in the study
- Incomplete responses to surveys and scales
- Being under the age of 18
- Not understanding Turkish
- Having any physical or mental problems that would prevent communication
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 yogaPart 1: Deep Breathing Exercises: Raise the arms up towards the sky and take a deep breath as possible and hold the breath for 4-5 seconds. This application is repeated several times. This section takes approximately 5-10 minutes. Part 2: Warm-up exercises: Hands are kept parallel to each other and clapped. The tips of the fingers and palms touch each other, the acupuncture points on both hands are stimulated and the individual's energy level increases. Section 3: Childish Games: In this section there are childish games. These games are visualized in the mind and the participants are asked to raise their arms upwards in the shape of the letter "Y".This section takes approximately 10 minutes. Section 4: Laughter Exercises: Participants are given verbal guidance such as "Put your hand on your heart, feel your heartbeat, let's exhale with a smile, let's make a wish or pray" and the laughter exercise is terminated. This section takes approximately 15 minutes. | Other | Laughter yoga group |
Primary outcome
Quality of Life Scale During Pregnancy
Time frame: between 2 to 4 weeks
It aims to optimally evaluate the quality of life of women with normal pregnancies and consists of nine items. It is a scale specific to singleton pregnancies that should be used in clinical and social research because it provides a better perspective on the quality of life of pregnant women rather than a general quality of life scale. The total score of the scale varies between 9-45, with higher scores indicating higher quality of life.There is no adverse substance in the scale. It can be used in every trimester
State-Trait Anxiety Inventory
Time frame: between 2 to 4 weeks
The lowest and highest scores that can be obtained from each subscale are 20 and 80, respectively. Higher scores are associated with more anxiety.
Psychometric Properties of Eurohis (Whoqol-8.Tr) Turkish Version in Turkish Society
Time frame: between 2 to 4 weeks
EUROHIS-QOL 8 was developed by the World Health Organization (WHO) in 2003. It consists of 8 items and was validated in Turkish by Eser et al in 2010. The total score determines the overall quality of life level; higher scores indicate higher quality of life
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 18 Jun 2026.
- 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.
AYCA SOLT KIRCA, Phd study chair
Kırklareli 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 Anxiety and Life Style, run by Kırklareli 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 9 inclusion and 6 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 18 Jun 2026. 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?
Quality of Life Scale During Pregnancy (time frame: between 2 to 4 weeks). 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 18 Jun 2026.