LaughterNCT07360184
The Effect of Laughter Yoga on Primiparous Pregnant Women
A study testing Laughter yoga in people with Laughter, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
Primiparous women constitute a special risk group who may experience higher levels of fear of childbirth and lower birth self-efficacy during pregnancy due to their lack of prior childbirth experience. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Laughter
- 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
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2026to 22 Mar 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being 18 years of age or older,
- never having given birth before
- be a primiparous pregnant woman experiencing her first birth,
- be pregnant with a single baby,
- be approximately 28-34 weeks pregnant at the start of the intervention,
- be planning a vaginal birth,
- have the ability to read and speak Turkish,
- volunteer to participate in the study
Who cannot join
- A diagnosis of high-risk pregnancy or the presence of serious obstetric complications that prevent participation in exercise (e.g., placenta previa, uncontrolled gestational hypertension or preeclampsia, bed rest recommended due to threatened preterm labor, cervical insufficiency),
- multiple pregnancy,
- history of recurrent pregnancy loss (≥2 miscarriages) or pregnancy achieved through assisted reproductive techniques (e.g., IVF),
- diagnosis of a known psychiatric disorder (major depression, anxiety disorder, psychosis, etc.),
- history of alcohol or substance use during pregnancy,
- Severe orthopedic problems or chronic respiratory system diseases that prevent participation in light exercise or laughter exercises,
- Participation in other structured prenatal interventions (e.g., prenatal yoga, hypno-birth, intensive childbirth education programs) aimed at reducing fear or anxiety about childbirth during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Laughter Yoga on Fear of Childbirth and Self-Efficacy During Childbirth in Primiparous Women: A Randomized Controlled Trial
Primiparous women constitute a special risk group who may experience higher levels of fear of childbirth and lower birth self-efficacy during pregnancy due to their lack of prior childbirth experience. Fear of childbirth is associated with increased anxiety, negative birth experiences, and unnecessary medical interventions, while birth self-efficacy is an important determinant of adaptation to the birth process and positive birth outcomes. In recent years, non-pharmacological and mind-body-based interventions have become increasingly important in the management of these psychological problems. Laughter yoga is a complementary method that combines conscious laughter exercises with breathing techniques to reduce stress and anxiety. This randomized controlled trial aims to evaluate the effect of laughter yoga on fear of childbirth and self-efficacy during childbirth in primiparous pregnant women. The study aims to provide scientific evidence for the use of laughter yoga as an effective, safe, and inexpensive psychosocial intervention that can be applied in prenatal care.
Read the detailed description
Primiparous pregnant women are considered a special risk group during pregnancy from a physical, psychological, and social perspective because they have not previously experienced childbirth. Primiparous pregnancy refers to a woman's first pregnancy, and during this process, women may experience more stress and psychological difficulties than multiparous women due to their lack of experience with childbirth, uncertainty, perceived loss of control, and concerns about the future. The literature indicates that primiparous women report higher levels of anxiety, stress, and psychological sensitivity during pregnancy, and that lack of knowledge and uncertainty about the birth process exacerbate these problems. For this reason, primiparous women are considered a priority group in terms of psychological support and protective interventions during the prenatal period.
One of the most commonly reported psychological problems in primiparous women is fear of childbirth. Fear of childbirth, defined in medical literature as tokophobia, is an intense fear of pregnancy and the birth process that can impair functioning and lead to avoidance behaviors. Studies show that primiparous pregnant women have significantly higher levels of fear of childbirth compared to multiparous women. This fear is related to expectations of labor pain, loss of control during childbirth, anxiety about medical interventions, and fears about possible complications. High levels of fear of childbirth can lead to negative outcomes in primiparous women, such as increased anxiety, prolonged labor, decreased satisfaction with childbirth, and increased requests for elective cesarean delivery without medical necessity. Furthermore, it has been reported that fear of childbirth can negatively affect mental health, mother-infant bonding, and breastfeeding in the postpartum period.
Another important concept closely related to fear of childbirth in primiparous women is self-efficacy in childbirth. Self-efficacy in childbirth refers to a woman's perceived confidence in her ability to cope with the physical and emotional challenges she will encounter during the birth process and is based on Bandura's self-efficacy theory. The literature shows that birth self-efficacy is lower in primiparous women than in multiparous women and that low self-efficacy levels are one of the key factors that increase fear of childbirth [6,11]. Primiparous women with low birth self-efficacy tend to believe that they will not be able to cope with labor pains, experience fear of losing control during birth, and develop negative expectations about childbirth. A study conducted in Turkey shows a significant and inverse relationship between perceived birth self-efficacy and fear of childbirth; it reveals that as self-efficacy increases, fear of childbirth decreases. These findings indicate that strengthening birth self-efficacy in primiparous women is an important goal in reducing fear of childbirth.
While pharmacological and medical approaches exist for managing fear of childbirth and low birth self-efficacy, non-pharmacological and complementary methods have gained increasing importance in recent years. One such method, laughter yoga, is a mind-body-based practice that combines conscious laughter exercises with breathing techniques. Laughter yoga is based on the principle that the brain does not distinguish between spontaneous and conscious laughter; it has been reported that even simulated laughter reduces stress hormones and increases endorphin release. The literature shows that laughter yoga has positive effects on stress, anxiety, and psychological well-being; it increases oxygenation, reduces muscle tension, and strengthens individuals' emotional resilience. In line with these mechanisms, laughter yoga is thought to reduce fear of childbirth in primiparous women, creating a more positive emotional state and strengthening the woman's self-confidence and birth self-efficacy.
The current literature includes studies examining the effects of yoga, relaxation exercises, and similar mind-body interventions during pregnancy on fear of childbirth and childbirth self-efficacy. There are also a limited number of randomized controlled trials showing the positive effects of laughter yoga on mental health, stress levels, and prenatal bonding during pregnancy. However, a review of the literature reveals no randomized controlled trials directly examining the effects of laughter yoga on fear of childbirth and self-efficacy during childbirth in primiparous pregnant women. This situation clearly demonstrates the need for studies that reveal the relationship between these variables and the potential effects of laughter yoga. This study aims to fill this important gap in the literature by evaluating the effects of laughter yoga on fear of childbirth and self-efficacy during childbirth in primiparous pregnant women.
- Conditions
- Laughter
- Being tested
- Laughter yoga
- Medical subject headings
- Laughter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laughter yogaBehavioural
Sessions will consist of warm-up and breathing exercises, guided intentional laughter exercises, diaphragmatic breathing and relaxation, followed by a short mindfulness and closing phase.
| Study group | Role | What they receive |
|---|---|---|
| Laughter | Experimental | group performing laughter yoga Receives: Behavioral: Laughter yoga |
| Control | No intervention | group not receiving intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wijma Childbirth Expectation/Experience Questionnaire - Version A (W-DEQ/ Version A)
It was developed by Klaas and Barbro Wijma to measure women's fear of childbirth. The scale consists of 33 items. Responses on the scale are numbered from 0 to 5 and are on a six-point Likert scale. 0 means "completely," and 5 means "not at all." The minimum score on the scale is 0, while the maximum score is 165. As the score increases, so does the fear of childbirth experienced by women. While the first version of the scale did not specify a score range, subsequent studies determined a scoring range. This range can be used when interpreting scale scores. The total item score is interpreted as 0-60 for low fear of childbirth, 61-84 for moderate fear of childbirth, and 85 and above for high fear of childbirth.
Measured: Baseline (Day 0) and Week 4
Secondary outcomes (1)
Self-Efficacy Scale in Childbirth (SEB-C32)
The Self-Efficacy Scale for Childbirth was developed by Lowe (1993) to assess women's confidence and coping ability during childbirth. The short version of the scale was later developed by Ip et al. The Turkish validity and reliability study was conducted by Ersoy, with a Cronbach's alpha coefficient of 0.90. The scale consists of two subscales-outcome expectation and efficacy expectation-each comprising 16 items. Total scores range from 32 to 320, with higher scores indicating greater self-efficacy for childbirth. Items are rated on a 10-point Likert scale, with higher scores reflecting higher perceived competence and positive outcome expectations.
Measured: Baseline (Day 0) and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 Feb 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion22 Mar 2026 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Bal, Bozok University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07360184
- Sponsor's protocol ID
- ASYO
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laughter Yoga on Fear of Childbirth and Self-Efficacy During Childbirth in Primiparous Women: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07360184
- Acronym / sponsor ID
- ASYO
- Conditions
- Laughter
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 22 Mar 2026 (estimated)
- First posted
- 22 Jan 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.
Primiparous women constitute a special risk group who may experience higher levels of fear of childbirth and lower birth self-efficacy during pregnancy due to their lack of prior childbirth experience. Fear of childbirth is associated with increased anxiety, negative birth experiences, and unnecessary medical interventions, while birth self-efficacy is an important determinant of adaptation to the birth process and positive birth outcomes. In recent years, non-pharmacological and mind-body-based interventions have become increasingly important in the management of these psychological problems. Laughter yoga is a complementary method that combines conscious laughter exercises with breathing techniques to reduce stress and anxiety. This randomized controlled trial aims to evaluate the effect of laughter yoga on fear of childbirth and self-efficacy during childbirth in primiparous pregnant women. The study aims to provide scientific evidence for the use of laughter yoga as an effective, safe, and inexpensive psychosocial intervention that can be applied in prenatal care.
Detailed description
Primiparous pregnant women are considered a special risk group during pregnancy from a physical, psychological, and social perspective because they have not previously experienced childbirth. Primiparous pregnancy refers to a woman's first pregnancy, and during this process, women may experience more stress and psychological difficulties than multiparous women due to their lack of experience with childbirth, uncertainty, perceived loss of control, and concerns about the future. The literature indicates that primiparous women report higher levels of anxiety, stress, and psychological sensitivity during pregnancy, and that lack of knowledge and uncertainty about the birth process exacerbate these problems. For this reason, primiparous women are considered a priority group in terms of psychological support and protective interventions during the prenatal period.
One of the most commonly reported psychological problems in primiparous women is fear of childbirth. Fear of childbirth, defined in medical literature as tokophobia, is an intense fear of pregnancy and the birth process that can impair functioning and lead to avoidance behaviors. Studies show that primiparous pregnant women have significantly higher levels of fear of childbirth compared to multiparous women. This fear is related to expectations of labor pain, loss of control during childbirth, anxiety about medical interventions, and fears about possible complications. High levels of fear of childbirth can lead to negative outcomes in primiparous women, such as increased anxiety, prolonged labor, decreased satisfaction with childbirth, and increased requests for elective cesarean delivery without medical necessity. Furthermore, it has been reported that fear of childbirth can negatively affect mental health, mother-infant bonding, and breastfeeding in the postpartum period.
Another important concept closely related to fear of childbirth in primiparous women is self-efficacy in childbirth. Self-efficacy in childbirth refers to a woman's perceived confidence in her ability to cope with the physical and emotional challenges she will encounter during the birth process and is based on Bandura's self-efficacy theory. The literature shows that birth self-efficacy is lower in primiparous women than in multiparous women and that low self-efficacy levels are one of the key factors that increase fear of childbirth [6,11]. Primiparous women with low birth self-efficacy tend to believe that they will not be able to cope with labor pains, experience fear of losing control during birth, and develop negative expectations about childbirth. A study conducted in Turkey shows a significant and inverse relationship between perceived birth self-efficacy and fear of childbirth; it reveals that as self-efficacy increases, fear of childbirth decreases. These findings indicate that strengthening birth self-efficacy in primiparous women is an important goal in reducing fear of childbirth.
While pharmacological and medical approaches exist for managing fear of childbirth and low birth self-efficacy, non-pharmacological and complementary methods have gained increasing importance in recent years. One such method, laughter yoga, is a mind-body-based practice that combines conscious laughter exercises with breathing techniques. Laughter yoga is based on the principle that the brain does not distinguish between spontaneous and conscious laughter; it has been reported that even simulated laughter reduces stress hormones and increases endorphin release. The literature shows that laughter yoga has positive effects on stress, anxiety, and psychological well-being; it increases oxygenation, reduces muscle tension, and strengthens individuals' emotional resilience. In line with these mechanisms, laughter yoga is thought to reduce fear of childbirth in primiparous women, creating a more positive emotional state and strengthening the woman's self-confidence and birth self-efficacy.
The current literature includes studies examining the effects of yoga, relaxation exercises, and similar mind-body interventions during pregnancy on fear of childbirth and childbirth self-efficacy. There are also a limited number of randomized controlled trials showing the positive effects of laughter yoga on mental health, stress levels, and prenatal bonding during pregnancy. However, a review of the literature reveals no randomized controlled trials directly examining the effects of laughter yoga on fear of childbirth and self-efficacy during childbirth in primiparous pregnant women. This situation clearly demonstrates the need for studies that reveal the relationship between these variables and the potential effects of laughter yoga. This study aims to fill this important gap in the literature by evaluating the effects of laughter yoga on fear of childbirth and self-efficacy during childbirth in primiparous pregnant women.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laughter | Experimental | Behavioral: Laughter yogagroup performing laughter yoga |
| Control | No intervention | –group not receiving intervention |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Being 18 years of age or older,
- never having given birth before
- be a primiparous pregnant woman experiencing her first birth,
- be pregnant with a single baby,
- be approximately 28-34 weeks pregnant at the start of the intervention,
Key exclusion criteria (7 listed)
- A diagnosis of high-risk pregnancy or the presence of serious obstetric complications that prevent participation in exercise (e.g., placenta previa, uncontrolled gestational hypertension or preeclampsia, bed rest recommended due to threatened preterm labor, cervical insufficiency),
- multiple pregnancy,
- history of recurrent pregnancy loss (≥2 miscarriages) or pregnancy achieved through assisted reproductive techniques (e.g., IVF),
- diagnosis of a known psychiatric disorder (major depression, anxiety disorder, psychosis, etc.),
- history of alcohol or substance use during pregnancy,
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 yogaSessions will consist of warm-up and breathing exercises, guided intentional laughter exercises, diaphragmatic breathing and relaxation, followed by a short mindfulness and closing phase. | Behavioural | Laughter |
Primary outcome
Wijma Childbirth Expectation/Experience Questionnaire - Version A (W-DEQ/ Version A)
Time frame: Baseline (Day 0) and Week 4
It was developed by Klaas and Barbro Wijma to measure women's fear of childbirth. The scale consists of 33 items. Responses on the scale are numbered from 0 to 5 and are on a six-point Likert scale. 0 means "completely," and 5 means "not at all." The minimum score on the scale is 0, while the maximum score is 165. As the score increases, so does the fear of childbirth experienced by women. While the first version of the scale did not specify a score range, subsequent studies determined a scoring range. This range can be used when interpreting scale scores. The total item score is interpreted as 0-60 for low fear of childbirth, 61-84 for moderate fear of childbirth, and 85 and above for high fear of childbirth.
1 secondary outcome
Self-Efficacy Scale in Childbirth (SEB-C32)
Time frame: Baseline (Day 0) and Week 4
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 22 Jan 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 yoga in people with Laughter, run by Bozok 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 8 inclusion and 7 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: opening soon, as of the sponsor's last update on 22 Jan 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?
Wijma Childbirth Expectation/Experience Questionnaire - Version A (W-DEQ/ Version A) (time frame: Baseline (Day 0) and Week 4). 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 22 Jan 2026.