Physical Therapy Intervention for Puerperal Mastitis

Not Applicable

Completed

Conditions: Mastitis

Interventions: Other: Education
Other: Usual obstetric care
Other: Sham ultrasound
Other: Therapeutic ultrasound
Other: Breast massage

Registration Number: NCT04569136

Lead Sponsor: National Cheng Kung University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 37

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Education	* Educating the patient about mastitis and self-management strategies * Treating with therapeutic ultrasound * Administering and teaching breast massage
Sham group	Breast massage	* Educating the patient about mastitis and self-management strategies * Receiving sham ultrasound * Administering and teaching breast massage
Intervention group	Breast massage	* Educating the patient about mastitis and self-management strategies * Treating with therapeutic ultrasound * Administering and teaching breast massage
Sham group	Sham ultrasound	* Educating the patient about mastitis and self-management strategies * Receiving sham ultrasound * Administering and teaching breast massage
Usual care group	Usual obstetric care	Receiving usual obstetric care, which may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff
Intervention group	Therapeutic ultrasound	* Educating the patient about mastitis and self-management strategies * Treating with therapeutic ultrasound * Administering and teaching breast massage
Sham group	Education	* Educating the patient about mastitis and self-management strategies * Receiving sham ultrasound * Administering and teaching breast massage

Primary Outcome Measures

Name	Time	Method
Breast and Nipple Pain	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.

Secondary Outcome Measures

Name	Time	Method
Severity of Breast Engorgement	3 months	The degree of breast engorgement of the left and right breasts will be assessed using a six-point engorgement scale developed by Hill and Humenick. The higher scores indicate more severe breast engorgement (1=soft, no change, 2=slight change, 3=firm, non-tender, 4=firm, beginning tenderness, 5=firm, tender, 6=very firm and very tender).
Number of Participants Reporting Adverse Events	3 months	Adverse events will be recorded and reported as per Institutional Review Board, National Cheng Kung University Hospital guidelines on reporting adverse events and serious adverse events, with the absence of adverse or serious adverse events related to the physical therapy intervention used to indicate safety of the trial protocol.
Breast Hardness	3 months	The assessor will use a portable durometer to measure the hardness of left and right breasts. The participant will lie in a supine position and the durometer will be placed at 3 cm from both nipples in the 10 o'clock and 2 o'clock positions. The spring-loaded presser is pressed downwards until trigger switch on. Each position will be measured three times and the mean value will be obtained. The values range from 0-100. Higher values represent a worse outcome.
Acceptability of the Intervention Program	3 months	Acceptability of the intervention program will be assessed immediately post-intervention using a short questionnaire with 5-point Likert scale response to questions of 'how acceptable did you find the physical therapy interventions used in this study?' and 'how would you rate your overall satisfaction with the physical therapy program?' from 1 to 5, with 1 indicating very low acceptability or satisfaction and 5 indicating very high acceptability or satisfaction. The number of participants who rate a 5 (i.e. very high) on acceptability and satisfaction will be counted and recorded.
Breastfeeding Self-efficacy	3 months	Breastfeeding self-efficacy will be evaluated using the Breastfeeding Self-Efficacy Scale - Short Form (BSES-SF). The BSES-SF is a validated and reliable patient-reported outcome measure consisting of 14 items. Each item is scored between 1-5 points with 1 indicating 'not at all confident' and 5 indicating 'always confident'. Total scores range from 14 to 70, with higher scores indicating higher breastfeeding self-efficacy.
Volume of Mother's Milk	3 months	The volume of mother's milk will be measured by an electric breast pump for 15 minutes. Milk volumes will be recorded by weighing the collecting bottle on an electronic digital scale to the nearest 0.1 gram before and after each expression.
Body and Breast Temperature	3 months	Core body and breast temperatures will be measured using a non-contact infrared thermometer on the central part of the forehead and in the area 3 cm from both nipples in the 10 o'clock and 2 o'clock positions, respectively. The temperature of each position will be measured three times and the mean value will be recorded.