- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Muş, 터키 (Türkiye)
- Mus Alparslan University Campus, Diyarbakir Road 7th km, 49250 Mus Center/Mus
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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간섭 없음: No İntervention: Control Group
Routine prenatal care only, walking 30-min 3 times week for 8 week
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Postpartum Depression Score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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maternal Attachment
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
prenatal yoga에 대한 임상 시험
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Oslo University HospitalAkershus University Hospital, Lørenskog, Norway; Koc University Hospital, Istanbul, Turkey 그리고 다른 협력자들완전한우울증 | 스트레스 | 불명증 | 불안 | 낙천주의 | 대인 관계 이탈 | 전문적인 이행 | 일의 피로 | 자가 보고 의료 오류 | 의사 소진칠면조
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University of PittsburghPerelel Inc.모병