The Effect of Obstetric Exercises on Depression, Pregnancy Complaints and Quality of Life: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Depression Symptoms Assessed by BDI
研究概览
简要总结
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 obstetric exercises on depression, pregnancy-related complaints, and quality of life 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, closely supervised obstetric exercise program, while the control group will continue to receive routine prenatal care.
Data will be collected through a sociodemographic questionnaire, the Beck Depression Inventory (BDI), and the Pregnancy Symptoms Inventory (PSI). Post-intervention outcomes will be analyzed using independent-samples t-tests to compare groups, and multiple linear regression will be applied to determine the influence of sociodemographic factors on study variables.
This study is expected to contribute to the evidence base by clarifying the potential role of obstetric exercise in reducing depressive symptoms, alleviating pregnancy complaints, and improving maternal quality of life within routine prenatal care settings.
详细描述
This randomized controlled trial is designed to evaluate the effectiveness of a structured obstetric exercise program on maternal mental health and pregnancy-related outcomes. The study will be conducted in the antenatal clinic and pregnancy school of a public hospital in eastern Türkiye, with a total of 100 pregnant women enrolled. Participants will be randomly allocated into two parallel groups: an intervention group (n=50) and a control group (n=50). Randomization will be performed using a computer-generated allocation sequence to minimize selection bias.
The intervention consists of a four-week exercise program developed specifically for pregnant women, led and closely supervised by a physiotherapist trained in maternal health. Sessions will take place three times per week, each lasting approximately 45-60 minutes, and will include a combination of breathing exercises, stretching, posture training, and low-intensity strengthening movements adapted for pregnancy. Exercise intensity and duration will be progressively adjusted according to gestational age, maternal comfort, and current obstetric guidelines. To ensure safety, maternal vital signs and fetal well-being will be monitored before and after each session. Participants will also receive verbal instructions on safe daily activity modifications and home practice recommendations.
The control group will receive standard prenatal care provided by the antenatal clinic, without additional structured exercise training. Both groups will continue to have access to routine obstetric monitoring, counseling, and educational materials typically offered by the hospital's pregnancy school.
Primary data will be collected using validated self-report instruments:
Beck Depression Inventory (BDI): to assess depressive symptoms. Pregnancy Symptoms Inventory (PSI): to evaluate frequency and severity of common pregnancy-related complaints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 45 years
- •Low-risk singleton pregnancy confirmed by ultrasound
- •No chronic illness
- •No psychiatric disorder
- •No physical disability
- •Voluntary agreement to participate in the study
- •Gestational age between 28 and 42 weeks (third trimester)
排除标准
- •Body mass index (BMI) ≥ 40 kg/m² or ≤ 18 kg/m²
- •Concurrent participation in another exercise or psychosocial intervention study
- •Failure to attend at least one exercise session
研究组 & 干预措施
Exercise group
Participants in the intervention group will take part in a four-week obstetric exercise program designed specifically for pregnant women. The program will be led by a licensed physiotherapist and delivered in small group sessions at the hospital's pregnancy school. Exercises will focus on relaxation, breathing techniques, stretching, posture correction, and low-impact strengthening movements appropriate for pregnancy. Sessions will be closely supervised to ensure safety and adapted to each participant's gestational stage and physical capacity. In addition to routine prenatal care, participants in this group will receive structured, physiotherapist-led exercise sessions once a week for four weeks.
干预措施: Obstetric exercises (Other)
Control group
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.
结局指标
主要结局
Change in Depression Symptoms Assessed by BDI
时间窗: At enrollment
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.
Change in Pregnancy-Related Complaints Assessed by PSI
时间窗: At enrollment
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.
次要结局
- Change in Depression Symptoms Assessed by BDI(At baseline and immediately post-intervention (4 weeks))
- Change in Pregnancy-Related Complaints Assessed by PSI(At baseline and immediately post-intervention (4 weeks))
研究者
Mehmet Kaplan
Asst. Prof.
Bingol University