- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07839962
The Effects of Innatal Yoga Practices on Pain, Comfort, and Satisfaction in Primiparous Women
The aim of this study is to examine the effects of prenatal yoga practices on labor pain, comfort level during labor, and overall birth satisfaction in primiparous pregnant women in Turkey. This study, which will be conducted using a randomized controlled trial design, aims to measure both the physical contribution of prenatal yoga practice to the birthing process and its effects on psychological well-being and satisfaction, thereby providing evidence-based recommendations to improve the quality of childbirth services.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Childbirth is a significant turning point in a woman's life cycle, both physiologically and psychologically. For primiparous women, especially first-time mothers, this process can be filled with intense pain, uncertainty, anxiety, and stress. Research shows that 60% to 80% of women worldwide experience anxiety and fear during childbirth (Bharati, Pokhrel & Bhandari, 2024). A study conducted in Turkey found that 66.3% of pregnant women experienced high levels of fear related to labor pains. Fear of childbirth is not only a psychological experience but can also negatively impact the physiological functioning of the birthing process. Intense fear of childbirth can lead to prolonged labor, an increase in the preference for cesarean sections, and the development of problems such as postpartum depression or post-traumatic stress disorder. Furthermore, the negative impact of fear of childbirth on birth self-efficacy makes the birthing experience more challenging for primiparous women. Key causes of fear of childbirth include intolerance to pain, concern about harming the mother or baby, fear of losing control during labor, and distrust of healthcare personnel. These fears are experienced more intensely, especially in women who have never given birth before; comparative studies have found that primiparous women have significantly higher levels of fear compared to multiparous women. Negative emotions experienced during childbirth directly affect a mother's comfort during labor, her satisfaction with the birth, and her postpartum well-being. Although pain is a natural part of childbirth, how this process is managed, the mother's overall perception of childbirth, and its duration play a decisive role. According to the World Health Organization, the global cesarean section rate is 21%, while in Türkiye this rate has reached 58% (Turkish Statistical Institute, 2023). This situation once again emphasizes the importance of managing the fear of childbirth and pain. In conclusion, it appears that yoga practices help reduce fear of childbirth, contribute to women developing a positive perception of childbirth, and increase satisfaction with birth.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Handan ASATEKİN YAZGU, PhD
- Phone Number: +90 507-181-3511
- Email: h.asatekin@alparslan.edu.tr
Study Locations
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Mus Center
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Muş, Mus Center, Turkey (Türkiye), 49250
- Mus Alparslan University Campus, Diyarbakir Road 7th km, 49250 Mus Center/Mus,
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Volunteers to participate in the study,
- Able to communicate in Turkish,
- Literate,
- Not diagnosed with any high-risk pregnancy,
- Primiparous (first pregnancy),
- In latent phase (dilation 0-5 cm) upon admission to the delivery room,
- Not having a previous psychiatric diagnosis,
- Pregnant women without any identified maternal or infant risk factors during their pregnancy.
Exclusion Criteria:
- Pregnant women who give birth via cesarean section and do not meet the inclusion criteria will be excluded from the study.
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: innatal yoga group
Primiparous pregnant women arriving at the hospital for delivery will be randomly divided into two groups after admission to the delivery room (latent phase) if they meet the sampling criteria. The pregnant women will be informed about the study and their consent obtained through face-to-face interviews conducted by the researchers. Pregnant women with cervical dilation between 0-5 cm who are randomly selected for the study will complete a Personal Information Form, the Numerical Rating Scale (MRS), the Verbal Category Scale (VCS), and the Birth Comfort Scale (BCS). The pregnant women will perform 8 different innatal yoga poses determined by the researchers, each pose lasting 5 minutes, for a total of 40 minutes. Following the yoga practice, a vaginal examination will be performed by the same midwife, and the MRS, VCS, and BCS will be administered again. After labor, the Birth Satisfaction Scale-Short Form (BSS-S) will be administered to the women. |
Primiparous pregnant women with cervical dilation between 0-5 cm, who were randomly assigned to experimental and control groups, will be administered a Personal Information Form, the Numerical Rating Scale (MRS), the Verbal Category Scale (VCS), and the Birth Comfort Scale (BCS). Following this, only the pregnant women in the experimental group will perform 8 different yoga poses, each pose lasting 5 minutes, as determined by the researchers. Routine care will be provided to the control group. After the yoga session, a vaginal examination will be performed by the same midwife, and all pregnant women will be re-administered the MRS, VCS, and BCS. After labor, both the experimental and control groups will be administered the Birth Satisfaction Scale-Short Form (BSS-S). |
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No Intervention: routine primiparous group
Primiparous pregnant women arriving at the hospital for delivery will be randomly assigned to two groups after admission to the delivery room (latent phase), provided they meet the sampling criteria. These women in the control group will be informed about the study and their consent obtained through face-to-face interviews conducted by the researcher. Pregnant women with cervical dilation between 0-5 cm who were assigned to the control group after randomization will complete the Personal Information Form, the Numerical Rating Scale (MRS), the Verbal Category Scale (VCS), and the Birth Comfort Scale (BCS). After receiving routine care, the same midwife will perform a vaginal examination on the pregnant woman 40 minutes later, and the MRS, VCS, and BCS will be administered again. Following labor, the Birth Satisfaction Scale-Short Form (BSS-S) will be administered to the pregnant women in the control group. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Yoga practices aim to reduce fear of childbirth, help women develop a positive perception of childbirth, and increase satisfaction with birth.
Time Frame: From the 0-5 cm cervical dilation range to the early postpartum period (4-24 hours)
|
The DMÖ-K is a 10-item scale using a five-point Likert type. The scale is scored as follows: "Strongly agree" (4 points), "Agree" (3 points), "Undecided" (2 points), "Disagree" (1 point), "Strongly disagree" (0 points). Items 2, 4, 7, and 8 are reverse-calculated. The lowest possible score is "0", and the highest is "40"; higher scores indicate higher satisfaction levels. |
From the 0-5 cm cervical dilation range to the early postpartum period (4-24 hours)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MusAlparslanU-SBF-HAZ-002
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
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