Physical Therapy Intervention for Puerperal Mastitis
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| ClinicalTrials.gov Identifier: NCT04569136 |
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Recruitment Status :
Recruiting
First Posted : September 29, 2020
Last Update Posted : March 22, 2023
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Sponsor:
National Cheng Kung University
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Kuan-Yin Lin, National Cheng Kung University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Mastitis | Other: Education Other: Therapeutic ultrasound Other: Sham ultrasound Other: Breast massage Other: Usual obstetric care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Physical Therapy Intervention for Puerperal Mastitis in Breastfeeding Women |
| Actual Study Start Date : | December 1, 2020 |
| Estimated Primary Completion Date : | July 1, 2023 |
| Estimated Study Completion Date : | October 31, 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
Experimental: Intervention group
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Other: Education
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. Other: Therapeutic ultrasound 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. Other: Breast massage 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. |
Sham Comparator: Sham group
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Other: Education
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. Other: Sham ultrasound Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist. Other: Breast massage 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. |
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Usual care group
Receiving usual obstetric care, which may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff
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Other: Usual obstetric care
Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff. |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 21 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569136
Contacts
| Contact: Kuan-Yin Lin, PhD | +886-6-2353535 ext 6737 | 10802003@gs.ncku.edu.tw |
Locations
| Taiwan | |
| National Cheng Kung University | Recruiting |
| Tainan, Taiwan, 704 | |
| Contact: Kuan Yin Lin +886 62353535 ext 5931 10802003@gs.ncku.edu.tw | |
Sponsors and Collaborators
National Cheng Kung University
Ministry of Science and Technology, Taiwan
Investigators
| Principal Investigator: | Kuan-Yin Lin, PhD | National Cheng Kung University |
Study Data/Documents:
Clinical Study Report
Publications:
Identifier: DOI：10.6315/2009.37(4)06
Publications:
| Responsible Party: | Kuan-Yin Lin, Assistant professor, National Cheng Kung University |
| ClinicalTrials.gov Identifier: | NCT04569136 |
| Other Study ID Numbers: |
MOST 109-2314-B-006-041-MY3 |
| First Posted: | September 29, 2020 Key Record Dates |
| Last Update Posted: | March 22, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Mastitis Puerperal Disorders Pregnancy Complications Female Urogenital Diseases and Pregnancy Complications |
Urogenital Diseases Breast Diseases Skin Diseases |