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临床试验/NCT06303232
NCT06303232招募中不适用

Combined Effects of Manual Lymphatic Drainage and Therapeutic Ultrasound on Breast Engorgement, Pain and Self Efficacy in Postpartum Women

Riphah International University2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2023年2月23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
42
试验地点
2
主要终点
Visual Analogue Scale - VAS

研究概览

简要总结

To find the combined effects of the manual lymphatic drainage with therapeutic ultrasound on breast engorgement, pain and self-efficacy in post - partum women.

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
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Both primiparous or multiparous breastfeeding women
  • BMI: ≤30-≥25 (14)
  • Immediate puerperium with normal or C - section non-premature childbirth (19)
  • Postnatal lactating mother with symptoms of breast engorgement

排除标准

  • any breast infection, abscess, mastitis, breast cancer
  • torn/bleeding or crack nipples
  • any skin condition like dermatitis, psoriasis etc
  • non-lactating mothers
  • having heart pacemaker

结局指标

主要结局

Visual Analogue Scale - VAS

时间窗: 7th day

VAS is an effective rule is measuring the pain score. It ranges from 0 -10 cm line scale with the following description; 0 cm = no pain 1 - 3 cm = mild pain 4 - 7 cm = moderate pain 8 - 10 cm = severe pain (20). When assessing the validity of VAS, a good-to-excellent correlation was found (r = 0.941), this scale had excellent test-retest reliability. The intra - class correlation coefficients of the VAS was 0.97

Six Point Engorgement Scale - SPE

时间窗: 7th day

Six point engorgement scale was the scale for the determination of the breast engorgement. The reliability of tool engorgement was 0.948 (22). The score of this scale ranges from 1 - 6. Every score has a following description; 1. = no changes in breast / soft breast 2. = slight changes in breast 3. = firm but no breast tenderness 4. = firm with starting breast tenderness 5. = tender and firm 6. = very tender and very firm

Breastfeeding Self-Efficacy Scale - BSES

时间窗: 7th day

It includes the 14 items that measure the confidence of the breastfeeding. 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). In sum, 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
Sponsor

研究点 (2)

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