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临床试验/CTRI/2025/09/095138
CTRI/2025/09/095138尚未招募3 期

The effect of alternating application of cold and hot compress on painful breast engorgement among postnatal mothers in postnatal wards at tertiary care hospital

Kumkum1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年10月15日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
142
试验地点
1
主要终点
the outcome of the study will be to reduce painful engorgement

研究概览

简要总结

Problem: Breast engorgement is a common, painful condition affecting many breastfeeding mothers in the first few weeks after childbirth. It can lead to discomfort, mastitis, and premature cessation of breastfeeding.

Purpose of the Study: To determine the effectiveness of alternately applying cold and hot compresses to reduce painful breast engorgement in postnatal mothers.

Background:

Breast engorgement occurs when breasts become overly full, hard, and painful due to lymphatic and vascular congestion and increased milk production.

It’s a significant reason for mothers to stop breastfeeding, affecting 72%-85% of mothers, typically 3-6 days postpartum.

Non-pharmacological methods like hot and cold compresses are increasingly popular due to concerns about medication side effects, ease of use, convenience, and lower cost.

Hot compresses are thought to trigger milk ejection and reduce edema, while cold compresses cause vasoconstriction, reducing blood flow, pain, and swelling.

Objectives:

To assess the pre-intervention score of painful breast engorgement.

To determine the effectiveness of the alternating application of cold and hot compresses in reducing painful breast engorgement.

To find an association between the pre-intervention engorgement score and selected demographic variables.

Hypothesis: There will be a significant difference in painful breast engorgement levels between pre-test and post-test after the alternating application of cold and hot compresses.

Methodology:

Research Approach & Design: Quantitative research using a Quasi-experimental design (non-randomized control design).

Setting: Department of Obstetrics and Gynecology, King George’s Medical University, Lucknow (specifically the postnatal ward of Queen Mary Hospital).

Population: Postnatal mothers experiencing painful breast engorgement (score > 3 on a six-point scale) within 1-5 days postpartum, who are conscious and willing to participate.

Sampling: Purposive sampling technique.

Sample Size: A minimum of 64 mothers per group (experimental and control), or 71 per group considering 10% attrition.

Variables:

Independent: Alternating application of cold and hot compress.

Dependent: Level of painful breast engorgement.

Tools:

Demographic variables form.

Bristol Breastfeeding Assessment Tool.

LATCH questionnaire.

Visual Analogue Pain Scale (VAS).

Six-Point Breast Engorgement Scale (SPES) for assessing engorgement level (1-2 mild, 3-5 moderate, 6-9 severe).

Expected Outcome (Implied): The study anticipates that the alternating application of cold and hot compresses will significantly reduce painful breast engorgement, thereby improving breastfeeding outcomes for postnatal mothers. This will provide evidence-based strategies for healthcare providers to better support breastfeeding mothers and contribute to the existing knowledge on effective engorgement management.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1.Postnatal mothers who are admitted to the postnatal ward Queen Mary Hospital Lucknow 2.Postnatal mothers whose breast engorgement is more than 3 in six-point scale 3.Postnatal mothers whose breasts are engorged and stayed in hospital for 1 to 5 days.

排除标准

  • • Postnatal mothers who are not willing to participate.
  • • Postnatal mothers who are sick or have a history of breast surgery.
  • • Postnatal mothers with cognitive impairment • Postnatal mothers with psychiatric illness.

结局指标

主要结局

the outcome of the study will be to reduce painful engorgement

时间窗: after 3 days

次要结局

  • the outcome of the study will be to reduce painful engorgement(outcome will be measured at 5 days)

研究者

发起方
Kumkum
申办方类型
Other [SELF ]
责任方
Principal Investigator
主要研究者

Kumkum

King Georges Medical University KGMU College of Nursing

研究点 (1)

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