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临床试验/NCT07489781
NCT07489781进行中(未招募)不适用

The Impact of a Mindfulness-Based Childbirth and Parenting Intervention and Prenatal Yoga on Birth Self-Efficacy, Fear of Childbirth, and Preferred Mode of Delivery in Primigravid Women

Trakya University1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2026年1月6日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
164
试验地点
1
主要终点
Childbirth Self-Efficacy Inventory - Short Form (CBSEI-SF)

研究概览

简要总结

(a) This thesis aims to examine the effects of counseling and prenatal yoga implemented within the scope of the Mindfulness-Based Childbirth and Parenting (MBCP) model on birth self-efficacy, fear of childbirth, and birth mode preferences among primigravid women. The planned study is expected to support the existing literature and constitutes an original contribution by addressing women's health from a holistic perspective.

(b) This prospective randomized controlled study is planned to be conducted face-to-face between January 2026 and February 2027 at Medipol Ankara Hospital and Hacettepe University with a total of n = 164 pregnant women who volunteer to participate in the study and have no previous birth experience (control: 41; intervention-1 [counseling based on the MBCP model]: 41; intervention-2 [prenatal yoga]: 41; intervention-3 [combined MBCP-based counseling and prenatal yoga]: 41).

Within the scope of the study, an 8-week intervention program including MBCP-based counseling and prenatal yoga will be implemented. Data will be collected using the Introductory Information Form developed in line with the literature, the Edinburgh Postnatal Depression Scale, the Personal Information Form, the Wijma Delivery Expectancy/Experience Questionnaire Version A (W-DEQ A), the Childbirth Self-Efficacy Inventory Short Form, the Fear of Childbirth Scale, and the Birth Mode Preference Scale.

The study will be conducted in accordance with the ethical principles of the Declaration of Helsinki, and the CONSORT checklist will be followed during the reporting process.

(c) The thesis will be carried out by a doctoral student in the thesis phase and their advisor at the Department of Nursing, Institute of Health Sciences, Eskişehir Osmangazi University.

(d) The findings of this thesis are expected to provide comprehensive evidence regarding the effects of MBCP-based counseling and prenatal yoga interventions on birth self-efficacy, fear of childbirth, and birth mode preferences among pregnant women. Furthermore, the results are anticipated to contribute significantly to academic, social, healthcare, and economic domains, and to support the strengthening of woman-centered care approaches in maternity services.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 49 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Volunteered to participate in the study,
  • Were between 18 and 45 years of age,
  • Were literate,
  • Were between 22 and 28 weeks of gestation,
  • Were primigravid,
  • Had a singleton viable pregnancy,
  • Were able to use a mobile phone or computer,
  • Scored ≤12 on the Edinburgh Postnatal Depression Scale (EPDS),
  • Had not previously received prenatal yoga training.

排除标准

  • Conceived through assisted reproductive techniques (ART),
  • Had a high-risk pregnancy,
  • Were multiparous,
  • Had a diagnosed psychiatric disorder or were receiving psychiatric treatment (as reported by the patient and/or physician),
  • Had a mental condition such as intellectual disability or dementia that could interfere with cooperation (as reported by the patient and/or physician),
  • Were currently participating in any individual or group psychotherapy or counseling program,
  • Had visual or hearing impairments that could hinder communication.

结局指标

主要结局

Childbirth Self-Efficacy Inventory - Short Form (CBSEI-SF)

时间窗: change from before implamentation patent and after 4st, and 8th week of practice

Scores obtained from each subscale range between 16 and 160, while the total score ranges from 32 to 320. Higher scores indicate higher levels of childbirth self-efficacy and more positive outcome expectations. The scale is rated on a 10-point Likert scale. In the outcome expectancy subscale, responses range from 1 ("not at all helpful") to 10 ("very helpful"). In the efficacy expectancy subscale, items 1-13 are scored from 1 ("completely sure") to 10 ("not at all sure"), whereas the remaining items are scored from 1 ("not at all sure") to 10 ("completely sure"). The first 13 items of the efficacy expectancy subscale are reverse-coded.

Fear of Childbirth Scale (FOCS)

时间窗: change from before implamentation patent and after 4st, and 8th week of practice

The Fear of Childbirth Scale consists of 10 items. Participants are asked to rate each item on a scale from 1 ("strongly disagree") to 10 ("strongly agree"). Five items (items 1, 3, 5, 7, and 10) are positively worded, and five items (items 2, 4, 6, 8, and 9) are negatively worded. The positively worded items are reverse-coded.

Pregnant Women's Birth Mode Preference Scale

时间窗: change from before implamentation patent and after 4st, and 8th week of practice

The scale consists of 18 items and three subscales: self-efficacy, normative beliefs, and preferences. It is rated on a 5-point Likert scale. Higher scores indicate stronger tendencies and attitudes within the subscales. This scale is a valid and reliable instrument for assessing psychosocial factors influencing pregnant women's preferences regarding mode of delivery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Burcu KUCUKKAYA

Assoc. Prof.

Trakya University

研究点 (1)

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