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临床试验/NCT06168630
NCT06168630招募中不适用

Effects of Manual Lymph Drainage on Breast Engorgement, Pain and Self Efficacy in Postpartum Period.

Riphah International University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年4月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Six point self rated engorgement scale

研究概览

简要总结

There have been many studies on the treatment of breast engorgement, there is a lack of research comparing the effectiveness of manual lymph drainage with massage. Therefore, this study will be a randomized controlled trial that aims to compare the effects of manual lymph drainage with massage on breast engorgement, pain, and self efficacy in the postpartum period.

详细描述

The study will be a randomized controlled trial and will be conducted in Jinnah hospital, Lahore. This study will be completed in time duration of 10 months after the approval of synopsis. Non probability convenience sampling technique will be used and 35 participants will be recruited in study after randomization. The subjects will be divided into two groups and the group A will receive manual lymph drainage and group B will receive massage whereas cold pack will be used as a baseline treatment. The tools that will be used for pre and post treatment assessment are NPRS, 6 point self rated engorgement scale and breast feeding self efficacy questionnaire. The data will be assessed after 5 days of treatment using 2 tailed t test. After data collection data will be analyzed by using SPSS version 25.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 25 to 35 years. Lactating mothers who presents with breast pain after birth. Women with breast heaviness. Women who rate themselves 4 on engorgement scale on six-point self-rated engorgement scale.

排除标准

  • Patients with gastrointestinal, urogynaecological, autoimmune or any neurological condition.
  • Women with breast cancer. Women with breast abcess. Women taking other medications.

结局指标

主要结局

Six point self rated engorgement scale

时间窗: 5th day

Six point self rated engorgemet scale is valid and reliable measures to assess breast engorgement and pain

Numerical pain rating scale

时间窗: 5th day

The Numerical pain rating scale is the most commonly used pain scale in the health care. This scale is used on subjects of age more than 9. By using this scale ask the participant to rate their pain orally by giving the numbers from 0-10

Breast feeding self efficacy questionnaire

时间窗: 5th day

The divergent validity of the BSES-SF was proved via a significant negative correlation with scores of the Edinburgh Postnatal Depression Scale (r = - 0.273, P \< 0.001). BSES-SF is a reliable and valid instrument for measuring breastfeeding self-efficacy

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

Adeela Arif

Senior Lecturer

Riphah International University

研究点 (1)

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