Depression During PregnancyBDI-PSINCT07170124
Obstetric Exercise and Maternal Outcomes in Pregnancy
A study testing Obstetric exercises in people with Depression During Pregnancy and Pregnancy, run by Bingol University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial will be conducted in the antenatal clinic and pregnancy school of a public hospital in eastern Türkiye. The study will aim to investigate the effects of a structured obstetric exercise program on pregnancy-related symptoms and their impact on daily functioning, as well as depressive… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression During Pregnancy, Pregnancy, Pregnancy Complications
- What is being tested?
- Obstetric exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2025to 27 Feb 2026
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45 years
- Low-risk singleton pregnancy confirmed by ultrasound
- Gestational age between 28 and 42 weeks at enrollment
- No diagnosed chronic disease or psychiatric disorder
- No physical disability limiting exercise
- Provision of written informed consent
Who cannot join
- Body mass index (BMI) ≥ 40 kg/m² or ≤ 18 kg/m²
- Concurrent participation in another exercise or psychosocial intervention study
- Development of an obstetric or medical complication contraindicating continued exercise during the study period (e.g., preterm labor, preeclampsia, vaginal bleeding, placenta previa, or premature rupture of membranes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Obstetric Exercises on Depression, Pregnancy Complaints and Quality of Life: A Randomized Controlled Trial
This randomized controlled trial will be conducted in the antenatal clinic and pregnancy school of a public hospital in eastern Türkiye. The study will aim to investigate the effects of a structured obstetric exercise program on pregnancy-related symptoms and their impact on daily functioning, as well as depressive symptoms, in women receiving prenatal care.
A total of 100 pregnant women will be recruited and randomly assigned to either the intervention group (n=50) or the control group (n=50). The intervention group will participate in a four-week, physiotherapist-led, supervised obstetric exercise program, while the control group will continue to receive routine prenatal care.
Read more
Data will be collected using a sociodemographic questionnaire, the Pregnancy Symptoms Inventory (PSI), and the Beck Depression Inventory (BDI). The primary outcome will be pregnancy-related symptom burden assessed using the PSI total score, and the secondary outcome will be self-reported depressive symptom severity assessed using the BDI.
This study is expected to contribute to the evidence base by clarifying the potential role of structured obstetric exercise in reducing pregnancy-related symptom burden and depressive symptom severity during the third trimester.
Read the detailed description
This randomized controlled trial is designed to evaluate the effects of a structured obstetric exercise program on pregnancy-related symptom burden and depressive symptoms among women in the third trimester of pregnancy. The study will be conducted in the antenatal clinic and pregnancy school of a public hospital in eastern Türkiye. A total of 100 pregnant women will be enrolled and randomly allocated in a 1:1 ratio to either an intervention group (n=50) or a control group (n=50). Randomization will be performed using a computer-generated allocation sequence.
The intervention group will participate in a four-week structured obstetric exercise program supervised by a physiotherapist. Participants will attend one supervised exercise session per week for four consecutive weeks, for a total of four supervised sessions. Each supervised session will last approximately 40-50 minutes and will consist of a warm-up phase, a main exercise phase, and a cool-down phase. The program will include low-intensity mobility and breathing exercises, low-load strengthening exercises targeting the trunk, pelvic, and lower-limb muscles, posture and pelvic-tilt exercises, stretching, and diaphragmatic breathing and relaxation exercises. Exercise intensity will be maintained at a moderate level and exercises will be progressively adjusted within a tolerable range.
In addition to the weekly supervised sessions, participants in the intervention group will be prescribed a home exercise program consisting of mobility, stretching, pelvic-tilt, breathing, and pregnancy-appropriate strengthening exercises. The home exercise program will be performed three days per week for approximately 40-50 minutes per session. Adherence to supervised sessions will be monitored using attendance records, while adherence to the home exercise program will be assessed through participant self-report. Participants will also be monitored for symptoms, exercise-related injuries, and obstetric or medical events occurring during the intervention period.
The control group will receive routine antenatal care, including standard prenatal check-ups and general prenatal counselling routinely provided at the clinic. Participants in the control group will not receive a structured exercise program or structured exercise counselling and will be asked to maintain their usual physical activity during the four-week study period.
Data will be collected at baseline, prior to randomization, and immediately after completion of the four-week intervention. Sociodemographic and obstetric characteristics will be assessed using a structured Personal Information Form. Pregnancy-related symptoms and their impact on daily functioning will be assessed using the Pregnancy Symptoms Inventory (PSI), while self-reported depressive symptom severity will be assessed using the Beck Depression Inventory (BDI).
The primary outcome will be the PSI total score, operationalized by combining the symptom-frequency ratings for the 42 pregnancy-related symptoms with the corresponding symptom-impact/daily-functioning ratings. Higher PSI total scores will indicate a greater overall burden of pregnancy-related symptoms and their impact on daily functioning. The secondary outcome will be self-reported depressive symptom severity assessed using the BDI, with higher scores indicating greater depressive symptom severity.
Between-group differences in post-intervention outcomes will be evaluated using analysis of covariance (ANCOVA), adjusting for the corresponding baseline outcome score. Gravidity will additionally be included as a covariate in the final adjusted analyses. The primary efficacy analysis will follow the intention-to-treat principle and will include all randomized participants in their originally allocated groups. Missing post-intervention outcome data will be handled using multiple imputation. A complete-case analysis will also be conducted as a sensitivity analysis. Statistical tests will be two-sided, with statistical significance set at p<0.05.
Ethical approval has been obtained from the relevant institutional research ethics committee, and institutional permission has been obtained from the relevant health authority. Written informed consent will be obtained from all participants prior to enrollment, and the study will be conducted in accordance with the principles of the Declaration of Helsinki.
This study aims to provide evidence regarding the effects of a structured, physiotherapist-supervised obstetric exercise program on pregnancy-related symptom burden and self-reported depressive symptom severity during the third trimester. The findings may contribute to the evaluation of structured exercise as a non-pharmacological approach within routine antenatal care.
- Being tested
- Obstetric exercises
- Keywords
- Obstetric exercise, Depression, Pregnancy symptoms, Quality of life
- Medical subject headings
- Pregnancy Complications, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obstetric exercisesOther
The intervention will consist of a structured obstetric exercise program administered by a physiotherapist who is permanently employed at the hospital's prenatal education center, ensuring the reliability and standardization of the intervention. The program will be based on the "Pregnancy and Exercise Guide" (2012) published by the Turkish Ministry of Health and will be delivered in the pregnancy school of a public hospital in eastern Türkiye.
The exercises will be provided at weekly intervals and will include:
Active joint movements to improve mobility and maintain functional range of motion,
Stretching exercises to enhance flexibility and alleviate musculoskeletal discomfort,
Calisthenic bodyweight exercises to promote muscle strength and endurance,
Relaxation and breathing techniques to reduce stress and improve maternal well-being.
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Participants in the intervention group will participate in a four-week structured obstetric exercise program supervised by a physiotherapist at the hospital's pregnancy school. The program will include one supervised exercise session per week for four consecutive weeks, for a total of four supervised sessions, with each session lasting approximately 40-50 minutes. The sessions will include mobility and breathing exercises, low-load strengthening exercises targeting the trunk, pelvic, and lower-limb muscles, posture and pelvic-tilt exercises, stretching, and diaphragmatic breathing and relaxation exercises. Exercise intensity will be maintained at a moderate level and progressively adjusted within a tolerable range. In addition to the supervised sessions, participants will be prescribed a home exercise program consisting of mobility, stretching, pelvic-tilt, breathing, and pregnancy-appropriate strengthening exercises to be performed three days per week for approximately 40-50 minutes Receives: Other: Obstetric exercises |
| Control group | No intervention | Participants in the control group will receive routine prenatal care provided by the hospital's antenatal clinic and pregnancy school. This includes standard obstetric follow-up, regular health check-ups, and educational counseling typically offered during pregnancy, but no structured obstetric exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy-Related Symptom Burden Assessed by the Pregnancy Symptoms Inventory (PSI)
The Pregnancy Symptoms Inventory (PSI) assesses 42 pregnancy-related symptoms. Each symptom is assessed for its frequency and, when present, its impact on daily functioning. In this study, the PSI outcome will be operationalized as a total score incorporating symptom-frequency ratings and the corresponding symptom-impact/daily-functioning ratings. Higher total scores indicate a greater overall burden of pregnancy-related symptoms and their impact on daily functioning. The primary outcome will be the post-intervention PSI total score, assessed after the four-week intervention, with between-group comparisons adjusted for the corresponding baseline PSI total score.
Measured: At enrollment
Secondary outcomes (3)
Change in Depression Symptoms Assessed by BDI
The Beck Depression Inventory (BDI) is a 21-item self-report scale measuring depressive symptoms. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63. Higher scores indicate more severe depressive symptoms (0-13 minimal, 14-19 mild, 20-28 moderate, 29-63 severe). The mean change in BDI total score from baseline to post-intervention will be compared between groups.
Measured: At baseline and immediately post-intervention (4 weeks)
Change in Pregnancy-Related Complaints Assessed by PSI
Pregnancy Symptoms Inventory (PSI): The scale consists of 42 items assessing the frequency of symptoms commonly experienced during pregnancy (e.g., fatigue, nausea, vomiting, reflux, constipation, dry mouth, cravings, insomnia). Each item is rated for frequency (0=never to 3=often) and limitation (0=not at all to 3=quite a lot). Higher scores indicate greater frequency and severity of complaints. The mean change in PSI total score from baseline to post-intervention will be compared between groups.
Measured: At baseline and immediately post-intervention (4 weeks)
Depressive Symptom Severity Assessed by the Beck Depression Inventory (BDI)
The Beck Depression Inventory (BDI) is a 21-item self-report instrument used to assess depressive symptom severity. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 63, with higher scores indicating greater depressive symptom severity. The secondary outcome is the post-intervention BDI total score assessed after the four-week intervention, with between-group comparisons adjusted for the corresponding baseline BDI score.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start20 Dec 2025
- Primary completion25 Jan 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression During 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bingol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Kaplan, Bingol University
- Investigators
- Mehmet Kaplan, Ph.D., Principal investigator, Bingol UniversityMesut Çelik, Ph.D., Study director, Bingol UniversityGülcan Çelik, Bachelor's Degree, Study chair, Bingöl State HospitalHalil Şimşek, Ph.D., Study chair, Bingol UniversityFatih Çakar, Ph.D., Study chair, Bingol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170124
- Sponsor's protocol ID
- E-33117789-044-126827
- Acronym
- BDI-PSI
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2025
- Last updated
- 7 Oct 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Obstetric Exercises on Depression, Pregnancy Complaints and Quality of Life: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07170124
- Acronym / sponsor ID
- BDI-PSI / E-33117789-044-126827
- Keywords
- Obstetric exercise, Depression, Pregnancy symptoms, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bingol UniversityUniversity, hospital or other
- Study start
- 20 Dec 2025 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 12 Sep 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.
This randomized controlled trial will be conducted in the antenatal clinic and pregnancy school of a public hospital in eastern Türkiye. The study will aim to investigate the effects of a structured obstetric exercise program on pregnancy-related symptoms and their impact on daily functioning, as well as depressive symptoms, in women receiving prenatal care.
A total of 100 pregnant women will be recruited and randomly assigned to either the intervention group (n=50) or the control group (n=50). The intervention group will participate in a four-week, physiotherapist-led, supervised obstetric exercise program, while the control group will continue to receive routine prenatal care.
Data will be collected using a sociodemographic questionnaire, the Pregnancy Symptoms Inventory (PSI), and the Beck Depression Inventory (BDI). The primary outcome will be pregnancy-related symptom burden assessed using the PSI total score, and the secondary outcome will be self-reported depressive symptom severity assessed using the BDI.
This study is expected to contribute to the evidence base by clarifying the potential role of structured obstetric exercise in reducing pregnancy-related symptom burden and depressive symptom severity during the third trimester.
Detailed description
This randomized controlled trial is designed to evaluate the effects of a structured obstetric exercise program on pregnancy-related symptom burden and depressive symptoms among women in the third trimester of pregnancy. The study will be conducted in the antenatal clinic and pregnancy school of a public hospital in eastern Türkiye. A total of 100 pregnant women will be enrolled and randomly allocated in a 1:1 ratio to either an intervention group (n=50) or a control group (n=50). Randomization will be performed using a computer-generated allocation sequence.
The intervention group will participate in a four-week structured obstetric exercise program supervised by a physiotherapist. Participants will attend one supervised exercise session per week for four consecutive weeks, for a total of four supervised sessions. Each supervised session will last approximately 40-50 minutes and will consist of a warm-up phase, a main exercise phase, and a cool-down phase. The program will include low-intensity mobility and breathing exercises, low-load strengthening exercises targeting the trunk, pelvic, and lower-limb muscles, posture and pelvic-tilt exercises, stretching, and diaphragmatic breathing and relaxation exercises. Exercise intensity will be maintained at a moderate level and exercises will be progressively adjusted within a tolerable range.
In addition to the weekly supervised sessions, participants in the intervention group will be prescribed a home exercise program consisting of mobility, stretching, pelvic-tilt, breathing, and pregnancy-appropriate strengthening exercises. The home exercise program will be performed three days per week for approximately 40-50 minutes per session. Adherence to supervised sessions will be monitored using attendance records, while adherence to the home exercise program will be assessed through participant self-report. Participants will also be monitored for symptoms, exercise-related injuries, and obstetric or medical events occurring during the intervention period.
The control group will receive routine antenatal care, including standard prenatal check-ups and general prenatal counselling routinely provided at the clinic. Participants in the control group will not receive a structured exercise program or structured exercise counselling and will be asked to maintain their usual physical activity during the four-week study period.
Data will be collected at baseline, prior to randomization, and immediately after completion of the four-week intervention. Sociodemographic and obstetric characteristics will be assessed using a structured Personal Information Form. Pregnancy-related symptoms and their impact on daily functioning will be assessed using the Pregnancy Symptoms Inventory (PSI), while self-reported depressive symptom severity will be assessed using the Beck Depression Inventory (BDI).
The primary outcome will be the PSI total score, operationalized by combining the symptom-frequency ratings for the 42 pregnancy-related symptoms with the corresponding symptom-impact/daily-functioning ratings. Higher PSI total scores will indicate a greater overall burden of pregnancy-related symptoms and their impact on daily functioning. The secondary outcome will be self-reported depressive symptom severity assessed using the BDI, with higher scores indicating greater depressive symptom severity.
Between-group differences in post-intervention outcomes will be evaluated using analysis of covariance (ANCOVA), adjusting for the corresponding baseline outcome score. Gravidity will additionally be included as a covariate in the final adjusted analyses. The primary efficacy analysis will follow the intention-to-treat principle and will include all randomized participants in their originally allocated groups. Missing post-intervention outcome data will be handled using multiple imputation. A complete-case analysis will also be conducted as a sensitivity analysis. Statistical tests will be two-sided, with statistical significance set at p<0.05.
Ethical approval has been obtained from the relevant institutional research ethics committee, and institutional permission has been obtained from the relevant health authority. Written informed consent will be obtained from all participants prior to enrollment, and the study will be conducted in accordance with the principles of the Declaration of Helsinki.
This study aims to provide evidence regarding the effects of a structured, physiotherapist-supervised obstetric exercise program on pregnancy-related symptom burden and self-reported depressive symptom severity during the third trimester. The findings may contribute to the evaluation of structured exercise as a non-pharmacological approach within routine antenatal care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Other: Obstetric exercisesParticipants in the intervention group will participate in a four-week structured obstetric exercise program supervised by a physiotherapist at the hospital's pregnancy school. The program will include one supervised exercise session per week for four consecutive weeks, for a total of four supervised sessions, with each session lasting approximately 40-50 minutes. The sessions will include mobility and breathing exercises, low-load strengthening exercises targeting the trunk, pelvic, and lower-limb muscles, posture and pelvic-tilt exercises, stretching, and diaphragmatic breathing and relaxation exercises. Exercise intensity will be maintained at a moderate level and progressively adjusted within a tolerable range. In addition to the supervised sessions, participants will be prescribed a home exercise program consisting of mobility, stretching, pelvic-tilt, breathing, and pregnancy-appropriate strengthening exercises to be performed three days per week for approximately 40-50 minutes |
| Control group | No intervention | –Participants in the control group will receive routine prenatal care provided by the hospital's antenatal clinic and pregnancy school. This includes standard obstetric follow-up, regular health check-ups, and educational counseling typically offered during pregnancy, but no structured obstetric exercise program. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 45 years
- Low-risk singleton pregnancy confirmed by ultrasound
- Gestational age between 28 and 42 weeks at enrollment
- No diagnosed chronic disease or psychiatric disorder
- No physical disability limiting exercise
Key exclusion criteria (3 listed)
- Body mass index (BMI) ≥ 40 kg/m² or ≤ 18 kg/m²
- Concurrent participation in another exercise or psychosocial intervention study
- Development of an obstetric or medical complication contraindicating continued exercise during the study period (e.g., preterm labor, preeclampsia, vaginal bleeding, placenta previa, or premature rupture of membranes)
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 |
|---|---|---|
| Obstetric exercisesThe intervention will consist of a structured obstetric exercise program administered by a physiotherapist who is permanently employed at the hospital's prenatal education center, ensuring the reliability and standardization of the intervention. The program will be based on the "Pregnancy and Exercise Guide" (2012) published by the Turkish Ministry of Health and will be delivered in the pregnancy school of a public hospital in eastern Türkiye. The exercises will be provided at weekly intervals and will include: Active joint movements to improve mobility and maintain functional range of motion, Stretching exercises to enhance flexibility and alleviate musculoskeletal discomfort, Calisthenic bodyweight exercises to promote muscle strength and endurance, Relaxation and breathing techniques to reduce stress and improve maternal well-being. | Other | Exercise group |
Primary outcome
Pregnancy-Related Symptom Burden Assessed by the Pregnancy Symptoms Inventory (PSI)
Time frame: At enrollment
The Pregnancy Symptoms Inventory (PSI) assesses 42 pregnancy-related symptoms. Each symptom is assessed for its frequency and, when present, its impact on daily functioning. In this study, the PSI outcome will be operationalized as a total score incorporating symptom-frequency ratings and the corresponding symptom-impact/daily-functioning ratings. Higher total scores indicate a greater overall burden of pregnancy-related symptoms and their impact on daily functioning. The primary outcome will be the post-intervention PSI total score, assessed after the four-week intervention, with between-group comparisons adjusted for the corresponding baseline PSI total score.
3 secondary outcomes
Change in Depression Symptoms Assessed by BDI
Time frame: At baseline and immediately post-intervention (4 weeks)
Change in Pregnancy-Related Complaints Assessed by PSI
Time frame: At baseline and immediately post-intervention (4 weeks)
Depressive Symptom Severity Assessed by the Beck Depression Inventory (BDI)
Time frame: At enrollment
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 7 Oct 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.
Mehmet Kaplan, Ph.D. principal investigator
Bingol University
Mesut Çelik, Ph.D. study director
Bingol University
Gülcan Çelik, Bachelor's Degree study chair
Bingöl State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Obstetric exercises in people with Depression During Pregnancy and Pregnancy, run by Bingol 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 3 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 7 Oct 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?
Pregnancy-Related Symptom Burden Assessed by the Pregnancy Symptoms Inventory (PSI) (time frame: At enrollment). 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 7 Oct 2026.