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临床试验/NCT07025265
NCT07025265已完成不适用

The Effect of Antenatal Education Based on the Breastfeeding Self-Efficacy Theory and Postpartum Follow-Up Counseling on Breastfeeding Self-Efficacy and Attitudes in Adolescent Pregnant Women

Saglik Bilimleri Universitesi1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in Breastfeeding Self-Efficacy Score

研究概览

简要总结

Adolescence is the period between the ages of 10 and 19, during which individuals undergo physiological, biological, psychological, and social development, transitioning from childhood to adulthood. Pregnancies occurring during this period are defined as adolescent pregnancies. In developing countries, approximately 21 million adolescent pregnancies occur annually among individuals aged 15-19, resulting in around 12 million births. According to national demographic data, a certain percentage of adolescent women have already started childbearing. Pregnancies occurring during this stage, when physical and psychosocial development is still incomplete, bring various medical and social challenges.

Adolescent pregnancies are associated with increased maternal and fetal mortality and morbidity risks and are classified as high-risk pregnancies. Therefore, adolescent mothers require close follow-up during both the antenatal and postpartum periods. However, studies indicate that adolescent mothers often fail to attend regular antenatal check-ups, receive inadequate education on breastfeeding, and consequently feel unprepared for motherhood. They tend to have low breastfeeding self-efficacy and develop negative attitudes toward breastfeeding. In the postpartum period, they also experience difficulties in initiating and maintaining breastfeeding.

Research highlights the need for education and counseling for adolescent mothers during the antenatal and postpartum periods. Providing education on breastfeeding is particularly important for improving maternal and infant health outcomes. Current approaches to breastfeeding counseling involve face-to-face training provided by healthcare professionals in medical institutions, as well as various alternative methods such as home visits, online/web-based education portals, theory-based training, text messages, emails, and phone consultations. In breastfeeding counseling, it is essential to not only provide education but also ensure continuous follow-up. Monitoring the process is expected to increase adolescent mothers' breastfeeding self-efficacy, foster positive attitudes toward breastfeeding, and extend the duration of breastfeeding.

This study aims to assess the effects of antenatal education based on the Breastfeeding Self-Efficacy Theory and postpartum follow-up counseling on adolescent mothers' breastfeeding attitudes and self-efficacy. By enhancing their breastfeeding self-efficacy and attitudes, this study is expected to contribute to resolving challenges related to early initiation and continuation of breastfeeding in the postpartum period.

详细描述

Study Population and Sample

The study population consisted of adolescent pregnant women registered at family health centers in Şanlıurfa, Türkiye.

The sample size was calculated using G*Power version 3.1.9.7. The calculation was based on a two-group, two-time-point repeated-measures analysis of variance for the group-by-time interaction, with a medium effect size of f = 0.25, a statistical power of 95%, and a two-sided significance level of 0.05. The required sample size was estimated as 54 participants, with 27 participants in each group. To account for possible attrition, the sample size was increased by approximately 10%. A total of 60 participants were enrolled and randomly assigned to the intervention group or the control group in a 1:1 ratio. Fifty-five participants completed the study.

Study Design and Randomization

This was a two-arm, parallel-group randomized controlled trial. Participants who met the eligibility criteria and provided written informed consent were assigned to the intervention or control group using a computer-generated 1:1 randomization list created through Randomizer.org.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

Due to the nature of the intervention, participants, the intervention provider, and the outcomes assessor were not blinded to group allocation. The intervention and posttest data collection were conducted by the same researcher. Statistical analyses were performed by an independent statistician who was blinded to the group codes.

入排标准

年龄范围
16 Years 至 19 Years(Child, Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Adolescent pregnant women aged 16-19 years
  • •Gestational age of 32 weeks or more at enrollment
  • •A healthy pregnancy without a known maternal or fetal complication that would interfere with participation in the study
  • •No known maternal or fetal condition contraindicating breastfeeding
  • •Able to communicate with the researcher and complete the study procedures
  • •Access to a reachable telephone
  • •Provision of written informed consent
  • •Singleton pregnancy
  • •Planning to breastfeed postpartum
  • •No previous breast surgery
  • •No psychiatric disorder
  • •No planned relocation

排除标准

  • •A maternal or fetal complication identified before enrollment that could lead to pregnancy loss or prevent participation in the study
  • •A known maternal condition contraindicating breastfeeding
  • •A communication barrier that would prevent completion of the education, counseling, or study assessments

研究组 & 干预措施

Intervention Group: Breastfeeding Self-Efficacy Theory-Based Education and Counseling

Experimental

Participants assigned to this arm received two individual, face-to-face antenatal breastfeeding education sessions based on Breastfeeding Self-Efficacy Theory. Following the education, weekly supportive text messages were sent until childbirth. Postpartum support included one home visit during the first postpartum week and five weekly telephone counseling sessions during postpartum weeks 2-6. Posttest data were collected at postpartum week 6.

干预措施: reastfeeding Self-Efficacy Theory-Based Antenatal Education and Postpartum Follow-Up Counseling (Behavioral)

Control Group: Routine Antenatal and Postpartum Care

No Intervention

Participants assigned to this arm received routine antenatal and postpartum care provided by healthcare professionals at the family health centers. No additional breastfeeding education, text-message support, home visit, or telephone counseling was provided by the research team during the study. Telephone contact was limited to confirming childbirth information and collecting posttest data at postpartum week 6. After posttest data collection was completed, breastfeeding education was offered to control-group participants who requested it.

结局指标

主要结局

Change in Breastfeeding Self-Efficacy Score

时间窗: Baseline and postpartum week 6

Breastfeeding self-efficacy was assessed using the 14-item Breastfeeding Self-Efficacy Scale-Short Form. The antenatal version was administered at baseline, and the postnatal version was administered at postpartum week 6. Each item is rated from 1 to 5. Total scores range from 14 (minimum) to 70 (maximum). Higher scores indicate a better outcome, reflecting greater breastfeeding self-efficacy. The outcome was defined as the change in the total score from baseline to postpartum week 6.

次要结局

  • Intervention Group Satisfaction With Breastfeeding Support(Postpartum Week 6)
  • Change From Baseline in Breastfeeding Knowledge Score(Baseline and postpartum week 6)
  • Change From Baseline in Breastfeeding Attitude Score(Baseline and postpartum week 6)

研究者

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

Hatice Nur Özgen

PhD Candidate in Obstetrics and Gynecology Nursing

Saglik Bilimleri Universitesi

研究点 (1)

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