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临床试验/NCT04569136
NCT04569136已完成不适用

Physical Therapy Intervention for Puerperal Mastitis in Breastfeeding Women

National Cheng Kung University2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
Breast and Nipple Pain

研究概览

简要总结

Puerperal mastitis is one of the most commonly reported problems during breastfeeding. Women frequently report breast pain, tenderness, redness, engorgement, fever, malaise, chills, lethargy, sweating, headache, nipple damage and a hot spot on the affected breast. These highly distressing symptoms may severely impact on a woman's daily activities and quality of life and might lead to the premature cessation of exclusive breastfeeding, which may have significant impact on infant health and survival. The role of physical therapy in reducing pregnancy/postpartum-related disorders including breast problems is gaining momentum and importance in obstetrics. However, to date, only low-level evidence has shown positive effects of breast massage, a physical technique, on pain, milk supply and symptom relief in women with breastfeeding problems. This is encouraging, however further research is needed to explore whether physical therapy is effective to reduce symptoms of puerperal mastitis. The investigators will conduct a prospective, assessor blinded single-center randomized controlled trial to assess the effectiveness of an individualized physical therapy program with therapeutic ultrasound, education and massage for patients with puerperal mastitis, compared to patients receiving usual obstetric care and sham ultrasound treatment.

详细描述

The high incidence of mastitis in breastfeeding women places health professionals working with postpartum women in key positions for managing women for symptoms of mastitis. This study aims to investigate the effectiveness of a physical therapy program for mastitis. The data the investigators collect from this study will provide evidence on effective and targeted strategies to achieve the goals of acceptable, effective and low risk physical therapy treatment of mastitis in postpartum women. Once these perspectives are known, recommendations on mastitis management can be made.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Have given birth at National Cheng Kung University Hospital (NCKUH)
  • Are Breastfeeding
  • Are aged 21-35
  • Are diagnosed with early stage mastitis
  • Have sufficient Chinese/Mandarin language skills to participate

排除标准

  • History of breast reduction or augmentation
  • An abscess
  • Severe physical/psychiatric impairments
  • Presence of any malignancies

结局指标

主要结局

Breast and Nipple Pain

时间窗: 3 months

Breast and nipple pain in the past 24 hours will be assessed using the numerical rating scale (NRS). Participants will be asked to rate her breast pain and nipple pain from 0 to 10 (11 point scale), with 0 indicating no pain and 10 indicating the worst possible pain.

次要结局

  • Severity of Breast Engorgement(3 months)
  • Number of Participants Reporting Adverse Events(3 months)
  • Breast Hardness(3 months)
  • Acceptability of the Intervention Program(3 months)
  • Breastfeeding Self-efficacy(3 months)
  • Volume of Mother's Milk(3 months)
  • Body and Breast Temperature(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kuan-Yin Lin

Assistant professor

National Cheng Kung University

研究点 (2)

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