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临床试验/NCT07413185
NCT07413185招募中不适用

Relationship Between the Severity of Sleep Deprivation in the First 48 Hours Postpartum, Breastfeeding Motivation, and Breastfeeding Success

Acibadem University1 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2026年3月12日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
167
试验地点
1
主要终点
Breastfeeding Success (LATCH Score)

研究概览

简要总结

The postpartum period is a critical time marked by significant physiological and psychosocial changes that can affect sleep, emotional well-being, and breastfeeding behaviors. Previous studies indicate that mode of delivery and sleep quality are closely associated with breastfeeding outcomes, with cesarean birth often linked to poorer sleep and lower breastfeeding success. Evidence also suggests that postpartum sleep disturbances are related to reduced breastfeeding self-efficacy, lower motivation, fatigue, depressive symptoms, and shorter breastfeeding duration.

However, the literature lacks studies that evaluate insomnia severity, breastfeeding motivation, and breastfeeding success simultaneously-particularly during the first 48 hours after birth. This analytical study aims to assess insomnia severity, breastfeeding motivation, and breastfeeding success (LATCH) within the first 48 postpartum hours and to examine the relationships among these variables. Findings are expected to support early postpartum clinical interventions to improve maternal and infant health outcomes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Primiparous or multiparous women aged 18 years and older
  • Having a healthy term delivery
  • Infant not admitted to the neonatal intensive care unit (NICU)
  • Initiated breastfeeding within the first 48 hours postpartum

排除标准

  • Complications requiring sedation
  • Severe postpartum hemorrhage
  • Severe postoperative pain or need for narcotic analgesics

结局指标

主要结局

Breastfeeding Success (LATCH Score)

时间窗: Within the first 48 hours postpartum (one-time assessment at enrollment)

Breastfeeding success will be assessed using the LATCH Breastfeeding Assessment Tool, which evaluates five domains: latch, audible swallowing, type of nipple, maternal comfort (breast/nipple), and holding/positioning. Each item is scored from 0 to 2, with a total score ranging from 0 to 10. Higher scores indicate greater breastfeeding success.

Insomnia Severity (Insomnia Severity Index, ISI)

时间窗: Within the first 48 hours postpartum (one-time assessment at enrollment)

Insomnia severity will be measured using the Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing difficulty initiating sleep, difficulty maintaining sleep, early morning awakening, satisfaction with sleep, interference with daytime functioning, noticeability of impairment, and distress caused by sleep problems. Each item is scored from 0 to 4, yielding a total score of 0-28. Higher scores indicate more severe insomnia.

Breastfeeding Motivation (Breastfeeding Motivation Scale Subscale Scores)

时间窗: Within the first 48 hours postpartum (one-time assessment at enrollment)

Breastfeeding motivation will be evaluated using the Breastfeeding Motivation Scale based on Self-Determination Theory. The scale includes 24 items rated on a 4-point Likert scale and provides scores for five subdomains: integrated regulation, intrinsic motivation/identified regulation, introjected regulation (social approval), introjected regulation (social pressure), and external regulation (secondary benefits). Subscale scores are calculated as the mean of items within each subdomain; higher scores indicate stronger motivation of that type.

Maternal and Neonatal Characteristics (Descriptive Data Form)

时间窗: Within the first 48 hours postpartum (one-time assessment at enrollment)

Participant demographic, obstetric, delivery-related, neonatal, breastfeeding history, breastfeeding-related characteristics, and sleep habit information will be collected using a structured descriptive information form developed by the researchers based on the literature.

次要结局

未报告次要终点

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Güzin Ünlü Suvari

Lecturer

Acibadem University

研究点 (1)

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