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Completed

NCT Number: NCT04569136

Physical Therapy Intervention for Puerperal Mastitis

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.

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Key information

Age range

21 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education

Other

The education session including education about mastitis, feeding techniques, lifestyle changes, thermal/cryo therapy and demonstration of breast self-massage will take approximately 20 minutes.

therapeutic ultrasound

Other

Participants will be treated with 5 minutes of therapeutic ultrasound (pulsed mode) at a frequency of 1 Mega Hertz, a duty cycle of 20%, a pulse intensity of 1.8 Watt/centimetre squared. The ultrasound probe will be moved at a speed of about 4 centimetre/second. The intensity and duration will be adjusted if the patient complains of discomfort. The ultrasound transducer head will massage over the tender point on the breast.

Sham ultrasound

Other

Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.

Breast massage

Other

Breast massage includes general and focused massage. Participants will lie in supine position. The breast massage will be applied according to the Vodder method to the affected breast.

Usual obstetric care

Other

Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff.

Primary outcomes

  1. Breast and Nipple Pain

    Time frame: 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 outcomes

  1. Severity of Breast Engorgement

    Time frame: 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).

  2. Breast Hardness

    Time frame: 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.

  3. Body and Breast Temperature

    Time frame: 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.

  4. Volume of Mother's Milk

    Time frame: 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.

  5. Acceptability of the Intervention Program

    Time frame: 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.

  6. Number of Participants Reporting Adverse Events

    Time frame: 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.

  7. Breastfeeding Self-efficacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Collaborators

  • Ministry of Science and Technology, Taiwan

Registry information

Official study title

Physical Therapy Intervention for Puerperal Mastitis in Breastfeeding Women

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 29, 2020
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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