Clinical trial NCT04569136: Physical Therapy Intervention for Puerperal Mastitis
Official title: Physical Therapy Intervention for Puerperal Mastitis in Breastfeeding Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mastitis
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2020-09-29
Enrollment: 37
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Breast and Nipple Pain
timeFrame: 3 months
Secondary outcomes:
measure: Severity of Breast Engorgement
timeFrame: 3 months
measure: Breast Hardness
timeFrame: 3 months
measure: Body and Breast Temperature
timeFrame: 3 months
measure: Volume of Mother's Milk
timeFrame: 3 months
measure: Acceptability of the Intervention Program
timeFrame: 3 months
measure: Number of Participants Reporting Adverse Events
timeFrame: 3 months
measure: Breastfeeding Self-efficacy
timeFrame: 3 months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: Kuan-Yin Lin, PhD
role: PRINCIPAL_INVESTIGATOR
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