PregnancyNCT07794371
Effects of Laughter Yoga in the Third Trimester
A study testing laughter therapy in people with Pregnancy and Psychosocial Health, run by Agri Ibrahim Cecen University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancy is a physiological process during which a number of biological changes occur in a woman's body. This period represents an important turning point in the lives of women, whose reproductive capacity ensures the continuation of generations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, Psychosocial Health
- What is being tested?
- laughter therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2025to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being 18 years of age or older
- Having no communication barriers
- Applying for antenatal education during the study period
- Volunteering to participate in the study
- Being in the third trimester of pregnancy
- Having no condition that would prevent participation in laughter yoga sessions
Who cannot join
- Refusing to participate in the study
- Providing incomplete responses or failing to answer the questions in the questionnaire
- Having a high-risk pregnancy
- Having a multiple pregnancy (e.g., twins)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ağrı İbrahim Çeçen University
Ağrı, Ağri, 04100
About this study
Official title: Laughter Yoga for Pregnant Women in the Third Trimester: Evaluation of Its Effects on Stress, Psychosocial Health, and Brain Fog
Pregnancy is a physiological process during which a number of biological changes occur in a woman's body. This period represents an important turning point in the lives of women, whose reproductive capacity ensures the continuation of generations. While some women perceive pregnancy as a source of joy and happiness because of the anticipated arrival of a new family member, others may perceive it as a source of worry, anxious anticipation, and stress.
In addition to physical and hormonal changes, expectant mothers experience numerous psychological and social changes during pregnancy. A woman's psychological state and experiences may influence the course of pregnancy, while pregnancy itself may also cause significant changes in her psychological state. Women who are unable to adequately adapt to these changes may experience various psychological problems due to pregnancy-related bodily changes and physical complaints, concerns about parenthood, changes in family and social roles, fear of childbirth, unwanted pregnancy and miscarriage, new challenges and needs arising from pregnancy, concerns and worries about the baby, parenting stress, low self-esteem, a persistent tendency toward negative thinking, lack of social support and social isolation, marital and partner-related problems, domestic violence, adverse life experiences, alcohol and tobacco use during pregnancy, chronic diseases, inadequate weight gain during pregnancy, exposure to sexual abuse, employment-related issues, and financial concerns. If these psychological problems arising during pregnancy are not resolved, emotional distress may continue to increase, potentially leading to stress and depression
Read more
Symptoms of brain fog, such as forgetfulness and absent-mindedness, may occur once or twice during pregnancy or may persist throughout pregnancy. Brain fog may become more pronounced during periods of fatigue or irregular sleep, such as in the early or late stages of pregnancy. Studies conducted among pregnant women have shown that fluctuations in progesterone and estrogen during pregnancy may lead to impairments in attention, memory, and executive functioning because the brain is sensitive to changes in hormone levels.
Laughter yoga (Laughter Therapy/Laughter Yoga), developed by Dr. Kataria, is a therapeutic method that combines yogic breathing techniques with laughter exercises. A systematic review reported that laughter yoga physiologically increases oxygenation, relaxes muscles, stimulates circulation and the immune system, increases endorphin release and thereby enhances the pain threshold and pain tolerance, strengthens mental functioning by reducing stress hormone levels, decreases depression and anxiety, improves sleep quality, and promotes psychological well-being by enhancing interpersonal relationships and social interaction. The literature highlights the positive physiological, psychological, and social effects of laughter on health. Although laughter yoga has increasingly been used in healthcare in recent years, positive outcomes have been reported across different age groups and health conditions. Laughter yoga performed with pregnant women has been reported to reduce the frequency of pregnancy-related symptoms and increase psychological well-being and prenatal attachment levels. However, no studies examining its effects on the outcomes addressed in the present study were identified in the literature. Therefore, this study aims to determine the effects of laughter yoga on perceived stress, psychosocial health, and brain fog among pregnant women in the third trimester.
Keywords: laughter, pregnancy, stress, psychosocial health, brain fog
- Conditions
- Pregnancy, Psychosocial Health
- Being tested
- laughter therapy
- Keywords
- lLaughter,, pregnancy,, stress,, psychosocial health,, brain fog
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laughter therapyOther
Participants will receive a total of 4-5 laughter therapy sessions during the study period.
| Study group | Role | What they receive |
|---|---|---|
| 1.laughter | Experimental | laughter therapy Receives: Other: laughter therapy |
| 2 CONTROL | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Information Form:
This form was developed by the researchers based on the relevant literature to assess the sociodemographic characteristics of the participants.
Measured: Baseline and immediately after completion of the final laughter yoga session
Perceived Stress Scale (PSS):
The scale, developed by Cohen et al., consists of 14 items and was designed to assess the extent to which situations in an individual's life are perceived as stressful. Participants rate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very Often (4)." Seven positively worded items are reverse-scored. In the Turkish adaptation, reliability, and validity study of the Perceived Stress Scale conducted by Eskin et al., the Turkish PSS-14 demonstrated an internal consistency coefficient of 0.84 and a test-retest reliability coefficient of 0.87. The scale was concluded to be a valid and reliable instrument for assessing perceived stress.
Measured: Baseline and immediately after completion of the final laughter yoga session
The Antenatal Psychosocial Health Assessment Scale
This scale was developed by Yıldız to assess psychosocial health during pregnancy. It consists of 46 items and six subscales: characteristics related to pregnancy and the spousal relationship, characteristics related to anxiety and stress, characteristics related to domestic violence, characteristics related to the need for psychosocial support, familial characteristics, and characteristics related to physical and psychosocial changes associated with pregnancy. The total score is divided by the number of items to obtain a mean score ranging from 1 to 5. Scores closer to 1 indicate greater psychosocial health problems during pregnancy, with a score of 1 representing very poor psychosocial health. The Cronbach's alpha coefficient of the scale was reported as 0.93.
Measured: Baseline and immediately after completion of the final laughter yoga session
Brain Fog Scale
The scale consists of 30 items and three subscales. The total score ranges from 30 to 150. The Cognitive Symptoms subscale is scored between 17 and 85, the Physical Symptoms subscale between 8 and 40, and the Psychological Symptoms subscale between 5 and 25. Higher scores on the subscales and/or the overall scale indicate higher levels of brain fog.
Measured: Baseline and immediately after completion of the final laughter yoga session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start30 Nov 2025
- Primary completion30 Mar 2026
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- None (open label)
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Agri Ibrahim Cecen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURTEN ÖZÇALKAP, Agri Ibrahim Cecen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794371
- Sponsor's protocol ID
- 2025 /37
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 31 Aug 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laughter Yoga for Pregnant Women in the Third Trimester: Evaluation of Its Effects on Stress, Psychosocial Health, and Brain Fog
- ClinicalTrials.gov ID
- NCT07794371
- Acronym / sponsor ID
- 2025 /37
- Conditions
- Pregnancy, Psychosocial Health
- Keywords
- lLaughter,, pregnancy,, stress,, psychosocial health,, brain fog
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Agri Ibrahim Cecen UniversityUniversity, hospital or other
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 31 Aug 2026 (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.
Pregnancy is a physiological process during which a number of biological changes occur in a woman's body. This period represents an important turning point in the lives of women, whose reproductive capacity ensures the continuation of generations. While some women perceive pregnancy as a source of joy and happiness because of the anticipated arrival of a new family member, others may perceive it as a source of worry, anxious anticipation, and stress.
In addition to physical and hormonal changes, expectant mothers experience numerous psychological and social changes during pregnancy. A woman's psychological state and experiences may influence the course of pregnancy, while pregnancy itself may also cause significant changes in her psychological state. Women who are unable to adequately adapt to these changes may experience various psychological problems due to pregnancy-related bodily changes and physical complaints, concerns about parenthood, changes in family and social roles, fear of childbirth, unwanted pregnancy and miscarriage, new challenges and needs arising from pregnancy, concerns and worries about the baby, parenting stress, low self-esteem, a persistent tendency toward negative thinking, lack of social support and social isolation, marital and partner-related problems, domestic violence, adverse life experiences, alcohol and tobacco use during pregnancy, chronic diseases, inadequate weight gain during pregnancy, exposure to sexual abuse, employment-related issues, and financial concerns. If these psychological problems arising during pregnancy are not resolved, emotional distress may continue to increase, potentially leading to stress and depression
Symptoms of brain fog, such as forgetfulness and absent-mindedness, may occur once or twice during pregnancy or may persist throughout pregnancy. Brain fog may become more pronounced during periods of fatigue or irregular sleep, such as in the early or late stages of pregnancy. Studies conducted among pregnant women have shown that fluctuations in progesterone and estrogen during pregnancy may lead to impairments in attention, memory, and executive functioning because the brain is sensitive to changes in hormone levels.
Laughter yoga (Laughter Therapy/Laughter Yoga), developed by Dr. Kataria, is a therapeutic method that combines yogic breathing techniques with laughter exercises. A systematic review reported that laughter yoga physiologically increases oxygenation, relaxes muscles, stimulates circulation and the immune system, increases endorphin release and thereby enhances the pain threshold and pain tolerance, strengthens mental functioning by reducing stress hormone levels, decreases depression and anxiety, improves sleep quality, and promotes psychological well-being by enhancing interpersonal relationships and social interaction. The literature highlights the positive physiological, psychological, and social effects of laughter on health. Although laughter yoga has increasingly been used in healthcare in recent years, positive outcomes have been reported across different age groups and health conditions. Laughter yoga performed with pregnant women has been reported to reduce the frequency of pregnancy-related symptoms and increase psychological well-being and prenatal attachment levels. However, no studies examining its effects on the outcomes addressed in the present study were identified in the literature. Therefore, this study aims to determine the effects of laughter yoga on perceived stress, psychosocial health, and brain fog among pregnant women in the third trimester.
Keywords: laughter, pregnancy, stress, psychosocial health, brain fog
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.laughter | Experimental | Other: laughter therapylaughter therapy |
| 2 CONTROL | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being 18 years of age or older
- Having no communication barriers
- Applying for antenatal education during the study period
- Volunteering to participate in the study
- Being in the third trimester of pregnancy
Key exclusion criteria (4 listed)
- Refusing to participate in the study
- Providing incomplete responses or failing to answer the questions in the questionnaire
- Having a high-risk pregnancy
- Having a multiple pregnancy (e.g., twins)
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 therapyParticipants will receive a total of 4-5 laughter therapy sessions during the study period. | Other | 1.laughter |
Primary outcome
Descriptive Information Form:
Time frame: Baseline and immediately after completion of the final laughter yoga session
This form was developed by the researchers based on the relevant literature to assess the sociodemographic characteristics of the participants.
Perceived Stress Scale (PSS):
Time frame: Baseline and immediately after completion of the final laughter yoga session
The scale, developed by Cohen et al., consists of 14 items and was designed to assess the extent to which situations in an individual's life are perceived as stressful. Participants rate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very Often (4)." Seven positively worded items are reverse-scored. In the Turkish adaptation, reliability, and validity study of the Perceived Stress Scale conducted by Eskin et al., the Turkish PSS-14 demonstrated an internal consistency coefficient of 0.84 and a test-retest reliability coefficient of 0.87. The scale was concluded to be a valid and reliable instrument for assessing perceived stress.
The Antenatal Psychosocial Health Assessment Scale
Time frame: Baseline and immediately after completion of the final laughter yoga session
This scale was developed by Yıldız to assess psychosocial health during pregnancy. It consists of 46 items and six subscales: characteristics related to pregnancy and the spousal relationship, characteristics related to anxiety and stress, characteristics related to domestic violence, characteristics related to the need for psychosocial support, familial characteristics, and characteristics related to physical and psychosocial changes associated with pregnancy. The total score is divided by the number of items to obtain a mean score ranging from 1 to 5. Scores closer to 1 indicate greater psychosocial health problems during pregnancy, with a score of 1 representing very poor psychosocial health. The Cronbach's alpha coefficient of the scale was reported as 0.93.
Brain Fog Scale
Time frame: Baseline and immediately after completion of the final laughter yoga session
The scale consists of 30 items and three subscales. The total score ranges from 30 to 150. The Cognitive Symptoms subscale is scored between 17 and 85, the Physical Symptoms subscale between 8 and 40, and the Psychological Symptoms subscale between 5 and 25. Higher scores on the subscales and/or the overall scale indicate higher levels of brain fog.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.
The record lists no contact. Use the official record to reach the sponsor.
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 therapy in people with Pregnancy and Psychosocial Health, run by Agri Ibrahim Cecen 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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 31 Aug 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?
This study is still under way. Results are not available in the source record yet.
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?
Descriptive Information Form: (time frame: Baseline and immediately after completion of the final laughter yoga session). The study lists 4 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 31 Aug 2026.