- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07583095
The Effect of Yoga Applied to Primiparous Pregnant Women on Postpartum Depression and Maternal Attachment
The Effect of Yoga Applied to Primiparous Pregnant Women on Postpartum Depression and Maternal Attachment: A Randomised Controlled Trial.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnancy is a physiological process for women; however, it is also a period that requires physical, mental, and social adaptation and is characterized by psychosocial changes, with a high risk of exposure to factors that may cause stress and anxiety. The extent to which pregnancy, considered a transition and adaptation period, is perceived as stressful varies greatly among individuals, and both the causes and perception of stress may differ between primiparous and multiparous women. Primiparous pregnant women experience many new and undefined emotions simultaneously and are unable to predict the events they may encounter during childbirth. Therefore, identifying and managing stress factors in the early stages is essential to support a positive pregnancy experience.Studies have shown that pregnant women generally perceive their prenatal stress levels as moderate to high, and that primiparous women experience higher levels of prenatal stress compared to multiparous women. Stress experienced during pregnancy may lead to numerous adverse effects on maternal, fetal, and neonatal health. It is suggested that stress during pregnancy is associated with postpartum depression. In addition, serious health problems such as depression and anxiety are commonly observed during pregnancy.Postpartum depression, also known as peripartum depression, is characterized by the onset of major depressive episode symptoms during the peripartum period. Its prevalence generally ranges between 10% and 20%, depending on the population and the timing and method of postpartum assessment. In our country, this rate varies between 12.5% and 28.1%. Postpartum depression affects mother-infant interactions such as breastfeeding, bonding, and maternal role functioning. By influencing the maternal role, postpartum depression negatively affects maternal attachment. Mothers with depressive symptoms tend to have lower levels of attachment and reduced sensitivity toward their infants.Maternal attachment refers to the emotional and behavioral bond established by the mother with her infant. This attachment process begins in the prenatal period and continues after birth as a reciprocal interaction between the mother and the baby. The mother-infant attachment process develops throughout pregnancy, childbirth, and the postpartum period and may be influenced by negative experiences related to these stages. As the level of postpartum depression increases, maternal attachment decreases. Mothers with postpartum depression have lower levels of maternal attachment compared to healthy mothers, and first-time motherhood has been associated with moderately impaired maternal bonding.Maternal attachment may begin during the prenatal period and is closely related to postpartum bonding. In the final trimester of pregnancy, women may experience ambivalent emotions toward their baby, feel discomfort related to pregnancy, desire the baby but fear childbirth, and experience higher levels of anxiety compared to earlier trimesters. Since maternal attachment is shaped through satisfactory and adequate interaction between the mother and the infant, it plays a significant role in reducing and minimizing symptoms of postpartum depression. Yoga, which has therapeutic effects on depression, stress, and anxiety, has been shown to positively influence the reduction of perceived maternal stress during pregnancy.Yoga is a mind-body practice that includes postures (asanas), deep breathing techniques (pranayama), and meditation. Asanas are specific physical positions that strengthen, purify, and balance the endocrine, nervous, and circulatory systems. When practiced regularly, asanas provide numerous physical and psychological benefits. Yoga is an adaptable form of exercise that can be easily modified and, when practiced regularly during pregnancy, can provide benefits for both the mother and the fetus.
Yoga during pregnancy has various psychological and physiological effects. It influences the release of beta-endorphins and neurotransmitters, leading to physiological and neurophysiological changes. By affecting the release of dopamine and serotonin, which are responsible for emotional regulation, it promotes relaxation. Regular yoga practice during the second and third trimesters has been found to be more effective than antenatal exercises in reducing anxiety and depression. Additionally, prenatal yoga has been reported to be effective in reducing depressive symptoms both during pregnancy and in the postpartum period.The prenatal and postnatal periods are distinct yet interconnected stages that play critical roles in the transition from pregnancy to early parenthood. These periods are important due to the associated risks of stress and postpartum depression. Therefore, women may consider yoga as an effective approach to facilitate adaptation to pregnancy and to cope with pregnancy-related challenges.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Muş, Turkey (Türkiye)
- Mus Alparslan University Campus, Diyarbakir Road 7th km, 49250 Mus Center/Mus
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18
- 26-28 weeks pregnant primipara
- At least primary school education
- Voluntary participation
Exclusion Criteria:
- High-risk pregnancy
- Chronic illness
- Psychiatric diagnosis
- Previous yoga/meditation experience
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental: Prenatal Yoga
prenatal yoga-40-min/week for 8 week
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In addition to routine prenatal care, participants in the intervention group will undergo an 8-week prenatal yoga program.
The yoga protocol will be conducted once a week for 40 minutes per session.
All sessions will be carried out face-to-face.
Participants in the intervention group will complete the 8-week yoga program.
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No Intervention: No İntervention: Control Group
Routine prenatal care only, walking 30-min 3 times week for 8 week
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum Depression Score
Time Frame: baseline and 1 months postpartum
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The primary aim of this randomized controlled trial is to evaluate the effectiveness of an 8-week prenatal yoga invtervention on reducing postpartum depression in primiparous women compared to routine prenatal care.
Measured by PDPI-R.The Postpartum Depression Predictors Inventory-Revised (PDPI-R) was developed to identify women at high risk for postpartum depression (PPD).
It consists of two versions: the prenatal version and the postpartum/full version.
The prenatal version is administered during pregnancy (third trimester) and consists of 32 items assessing 10 risk factors.
The postpartum/full version, administered during the postpartum period, includes a total of 39 items by adding three risk factors specific to the postpartum period (7 items) to the factors included in the prenatal version (32 items).The total score of the prenatal version ranges from 0 to 32, while the total score of the postpartum/full version ranges from 0 to 39. Higher scores indicate a higher risk for PPD.
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baseline and 1 months postpartum
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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maternal Attachment
Time Frame: baseline and 1 month postpartum
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the aim is to evaluate the effect of prenatal yoga on maternal-infant attachment at 1 month postpartum in primiparous women, measured by Maternal Attachment İnventory- MAI.
It is administered to women who have babies between one and four months postpartum.
The lowest score that can be obtained from the scale ranges from 26 to the highest score of 104, and a high score indicates a high level of maternal attachment.
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baseline and 1 month postpartum
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MusAlparslanU-SBF-HAY-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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