SleepNCT07085026
Effects of Yoga on Sleep and Stress in the Third Trimester of Pregnancy
A study testing Yoga Intervention in people with Sleep and Stress, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Many physiological and psychological changes occur during pregnancy. Sleep and stress are among these changes and can negatively impact the pregnancy process. Yoga can improve sleep quality and stress levels during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- What is being tested?
- Yoga Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Aug 2025to 1 Apr 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily agreed to participate in the study,
- Aged between 18 and 35 years,
- In the third trimester of pregnancy (between 29 and 42 weeks of gestation),
- Able to read and write in Turkish,
- No prior experience with yoga practice.
Who cannot join
- High-risk pregnancy,
- In the first or second trimester,
- Multiple pregnancy,
- Any condition that prevents yoga practice (e.g., restrictions on physical activity),
- Previous experience with yoga practice
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, 1 recruiting
- Recruiting
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine Prof. Dr. Murat Dilmener Hospital
Istanbul, Bakirköy, 34140
About this study
Official title: The Effect of Yoga Practiced in the Third Trimester on Sleep and Stress
Many physiological and psychological changes occur during pregnancy. Sleep and stress are among these changes and can negatively impact the pregnancy process. Yoga can improve sleep quality and stress levels during pregnancy. The purpose of this study was to evaluate the effects of yoga, implemented in the third trimester of pregnancy according to World Health Organization guidelines, on sleep and stress.
Read the detailed description
Pregnancy is defined as a period of both physiological and psychological changes in women. Although pregnancy and childbirth are natural processes, the physical, mental, and emotional adaptive changes that occur during this time can significantly impact a woman's health and pregnancy outcomes. Sleep problems are common during pregnancy. Toward the end of pregnancy, women often experience frequent nighttime awakenings, insomnia, and restless sleep. During pregnancy, women undergo bio-physio-psychosocial changes that can lead to increased stress. In order to prevent adverse outcomes, it is important to manage stress in pregnant women and implement interventions aimed at reducing high cortisol levels.
Yoga can be defined as a system of stretching exercises and postures (asanas) combined with deep breathing (pranayama) and meditation, aiming to unify the mind, body, and spirit.
There are studies that have evaluated the effects of yoga practice during pregnancy on sleep and stress. None of these studies have reported any negative effects of yoga on pregnancy. In all studies, yoga was applied with varying frequencies, durations, and techniques. However, no study has been found that evaluates the effects of a yoga program conducted in accordance with the recommendations of the World Health Organization (WHO, 2023) on both sleep and stress. Therefore, the aim of this study is to evaluate the effects of yoga, implemented during the third trimester of pregnancy in line with WHO guideline recommendations, on sleep and stress.
- Being tested
- Yoga Intervention
- Keywords
- yoga, sleep, stress, pregnancy, third trimester
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga InterventionBehavioural
There are studies that have evaluated the effects of prenatal yoga on sleep. None of these studies have reported any negative effects of yoga on pregnancy. In all studies, yoga practice was applied with varying frequencies, durations, and techniques. However, no research has been found that evaluates the effects of a yoga program conducted in accordance with the World Health Organization (WHO) guideline recommendations on both sleep and stress. Therefore, the aim of this study is to evaluate the effects of yoga, practiced during the third trimester of pregnancy in line with WHO guideline recommendations, on sleep and stress.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in this group will practice yoga in accordance with the WHO guideline recommendations. Receives: Behavioral: Yoga Intervention |
| Control Group | No intervention | Participants in this group will not receive yoga; routine care will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI).
The Pittsburgh Sleep Quality Index (PSQI) was developed to assess sleep quality and sleep disturbances over the past month. It consists of a total of 24 questions, 19 of which are self-rated items. The remaining 5 questions are used for clinical evaluation and are not included in the scoring. Each item in the scale is rated on a scale from 0 to 3. From the 19 self-rated items, 7 component scores are derived. Some components are based on a single item, while others are formed by combining several items. These components are: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score of the scale is obtained by summing the scores of these 7 components. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 indicates "poor sleep quality."
Measured: It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.
Secondary outcomes (1)
Perceived Stress Level
Maternal stress level assessed using the Perceived Stress Scale (PSS).
The Perceived Stress Scale (PSS) was developed to assess perceived stress over the past month. It consists of 14 items and is rated on a 5-point Likert scale ranging from "Never (0)" to "Very Often (4)". Seven of the items, which are positively stated, are reverse scored. The total score of the PSS-14 ranges from 0 to 56, with higher scores indicating greater levels of perceived stress.
Measured: It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start21 Aug 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pregnant participants will be randomly assigned to two groups in a 1:1 ratio. The intervention group will receive a yoga program in accordance with the WHO guideline recommendations, while the control group will receive no intervention and will continue with routine care.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Şengün, Istanbul University - Cerrahpasa
- Investigators
- Tülay TÜLAY Yılmaz, Associate Professor, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085026
- Sponsor's protocol ID
- IUC-SBF-GŞ-01
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 22 Aug 2025
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Yoga Practiced in the Third Trimester on Sleep and Stress
- ClinicalTrials.gov ID
- NCT07085026
- Acronym / sponsor ID
- IUC-SBF-GŞ-01
- Keywords
- yoga, sleep, stress, pregnancy, third trimester
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 25 Jul 2025 (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.
Many physiological and psychological changes occur during pregnancy. Sleep and stress are among these changes and can negatively impact the pregnancy process. Yoga can improve sleep quality and stress levels during pregnancy. The purpose of this study was to evaluate the effects of yoga, implemented in the third trimester of pregnancy according to World Health Organization guidelines, on sleep and stress.
Detailed description
Pregnancy is defined as a period of both physiological and psychological changes in women. Although pregnancy and childbirth are natural processes, the physical, mental, and emotional adaptive changes that occur during this time can significantly impact a woman's health and pregnancy outcomes. Sleep problems are common during pregnancy. Toward the end of pregnancy, women often experience frequent nighttime awakenings, insomnia, and restless sleep. During pregnancy, women undergo bio-physio-psychosocial changes that can lead to increased stress. In order to prevent adverse outcomes, it is important to manage stress in pregnant women and implement interventions aimed at reducing high cortisol levels.
Yoga can be defined as a system of stretching exercises and postures (asanas) combined with deep breathing (pranayama) and meditation, aiming to unify the mind, body, and spirit.
There are studies that have evaluated the effects of yoga practice during pregnancy on sleep and stress. None of these studies have reported any negative effects of yoga on pregnancy. In all studies, yoga was applied with varying frequencies, durations, and techniques. However, no study has been found that evaluates the effects of a yoga program conducted in accordance with the recommendations of the World Health Organization (WHO, 2023) on both sleep and stress. Therefore, the aim of this study is to evaluate the effects of yoga, implemented during the third trimester of pregnancy in line with WHO guideline recommendations, on sleep and stress.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pregnant participants will be randomly assigned to two groups in a 1:1 ratio. The intervention group will receive a yoga program in accordance with the WHO guideline recommendations, while the control group will receive no intervention and will continue with routine care.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Yoga InterventionParticipants in this group will practice yoga in accordance with the WHO guideline recommendations. |
| Control Group | No intervention | –Participants in this group will not receive yoga; routine care will be provided. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntarily agreed to participate in the study,
- Aged between 18 and 35 years,
- In the third trimester of pregnancy (between 29 and 42 weeks of gestation),
- Able to read and write in Turkish,
- No prior experience with yoga practice.
Key exclusion criteria (5 listed)
- High-risk pregnancy,
- In the first or second trimester,
- Multiple pregnancy,
- Any condition that prevents yoga practice (e.g., restrictions on physical activity),
- Previous experience with yoga practice
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 |
|---|---|---|
| Yoga InterventionThere are studies that have evaluated the effects of prenatal yoga on sleep. None of these studies have reported any negative effects of yoga on pregnancy. In all studies, yoga practice was applied with varying frequencies, durations, and techniques. However, no research has been found that evaluates the effects of a yoga program conducted in accordance with the World Health Organization (WHO) guideline recommendations on both sleep and stress. Therefore, the aim of this study is to evaluate the effects of yoga, practiced during the third trimester of pregnancy in line with WHO guideline recommendations, on sleep and stress. | Behavioural | Intervention Group |
Primary outcome
Sleep Quality
Time frame: It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.
Sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) was developed to assess sleep quality and sleep disturbances over the past month. It consists of a total of 24 questions, 19 of which are self-rated items. The remaining 5 questions are used for clinical evaluation and are not included in the scoring. Each item in the scale is rated on a scale from 0 to 3. From the 19 self-rated items, 7 component scores are derived. Some components are based on a single item, while others are formed by combining several items. These components are: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score of the scale is obtained by summing the scores of these 7 components. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 indicates "poor sleep quality."
1 secondary outcome
Perceived Stress Level
Time frame: It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.
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 Aug 2025.
- 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.
Tülay TÜLAY Yılmaz, Associate Professor study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Intervention in people with Sleep and Stress, run by Istanbul University - Cerrahpasa 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: looking for participants now, as of the sponsor's last update on 22 Aug 2025. 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?
Contact Gözde GÖZDE Şengün, Undergraduate (+905384262803, gozdeesengun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (time frame: It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.). 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 Aug 2025.