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临床试验/NCT07272252
NCT07272252招募中不适用

Psychological Effects and Breastfeeding Self-Efficacy of a Structured Four-Step Narrative Nursing Intervention in Cesarean Mothers: A Randomized Controlled Mixed-Methods Study

Xi Huang1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年10月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Postpartum anxiety at 48 hours

研究概览

简要总结

This study tests whether a nurse-led "4-step narrative nursing" program can reduce anxiety and improve breastfeeding confidence in mothers who are having a planned or non-emergency cesarean section.

What is the problem? About 30-40% of Chinese cesarean mothers feel high anxiety after surgery, and 1 in 5 is at risk for postpartum depression. Low confidence in breastfeeding is also common.

What will we do?

We will randomly assign 160 mothers (1:1) to either:

Usual care - standard education and ward care, or

Usual care plus narrative nursing - four short (10-20 min) conversations with a trained nurse:

Before surgery - help the mother talk about her fears. 24-48 h after surgery - encourage her to "name" pain or worries and separate them from herself.

Before discharge - guide her to find positive moments and build a "strong-mom" story.

Two weeks later by phone - strengthen the new story and review feeding success. What will we measure? Main result: anxiety score at 48 h (STAI scale). Other results: depression risk, breastfeeding confidence, pain, and feeding rates up to 3 months.

Possible benefits:

Lower anxiety, better mood, higher breastfeeding rates. No drugs or extra procedures are involved, only talking.

Risks:

Minimal; some mothers may feel emotional during conversations, but nurses can pause or refer to counselling if needed.

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
Single (Outcomes Assessor)

盲法说明

Single-center, two-arm, randomized, parallel-group, superiority trial with blinded outcome assessment.

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-50 years
  • Scheduled for elective or non-emergency cesarean section at ≥37 weeks
  • Able to communicate in Mandarin and provide written informed consent
  • Expected hospital stay ≥24 h
  • Singleton pregnancy with stable maternal and neonatal condition allowing routine mother-baby contact

排除标准

  • Severe psychiatric disorders (schizophrenia, bipolar disorder, active suicidal ideation)
  • Maternal or neonatal need for ICU/NICU admission
  • Emergency cesarean section preventing baseline assessment
  • Communication or cognitive impairment precluding interview

研究组 & 干预措施

Routine perinatal care

No Intervention

Participants receive standard ward education, nursing care, discharge instructions, and routine telephone follow-up without any additional narrative sessions.

4-step narrative nursing

Experimental

Participants receive usual care plus four nurse-led narrative sessions (pre-op externalization, post-op deconstruction, pre-discharge reconstruction, and 2-week meaning-reconstruction phone call) aimed at reducing anxiety and enhancing breastfeeding confidence.

干预措施: 4-step narrative nursing program (Behavioral)

结局指标

主要结局

Postpartum anxiety at 48 hours

时间窗: 48 hours post-surgery

Mean score on the State-Trait Anxiety Inventory (STAI-State, 20 items) assessed 48 hours after cesarean delivery. Lower scores indicate less anxiety.

次要结局

  • Postpartum depression risk(48 hours, 2 weeks, 3 months postpartum)
  • Breastfeeding self-efficacy(48 hours, 2 weeks, 3 months postpartum)
  • Pain intensity(48 hours and 2 weeks postpartum)
  • Breastfeeding continuation rate(3 months postpartum)

研究者

发起方
Xi Huang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Xi Huang

Master's student

Xiamen University

研究点 (1)

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