An interventional study of Education and Therapeutic ultrasound in Mastitis, sponsored by National Cheng Kung University. Completed at 1 site in Taiwan. Open to female participants aged 21 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-07-18.
Sponsored by National Cheng Kung University · Not applicable, Interventional, and Treatment
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.
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.
31 studies on the registry are indexed under Mastitis; 7 are open to participants now.
This study's enrollment of 37 is below the median of 114 across 16 interventional studies indexed under Mastitis.
Browse Mastitis studies →National Cheng Kung University is the lead sponsor of 63 studies on the registry; 12 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Educating the patient about mastitis and self-management strategies * Treating with therapeutic ultrasound * Administering and teaching breast massage
Other: Education · Other: Therapeutic ultrasound · Other: Breast massage
* Educating the patient about mastitis and self-management strategies * Receiving sham ultrasound * Administering and teaching breast massage
Other: Education · Other: Sham ultrasound · Other: Breast massage
Receiving usual obstetric care, which may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff
Other: Usual obstetric care
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.
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.
Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.
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 may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff.
Breast and Nipple Pain
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.
Time frame: 3 months
Severity of Breast Engorgement
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).
Time frame: 3 months
Breast Hardness
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.
Time frame: 3 months
Body and Breast Temperature
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.
Time frame: 3 months
Volume of Mother's Milk
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.
Time frame: 3 months
Acceptability of the Intervention Program
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.
Time frame: 3 months
Number of Participants Reporting Adverse Events
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.
Time frame: 3 months
Breastfeeding Self-efficacy
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.
Time frame: 3 months
| Milestone | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Started | 12 | 12 | 13 |
| Completed | 10 | 12 | 12 |
| Not completed | 2 | 0 | 1 |
| Withdrew: Lost to follow-up | 2 | 0 | 1 |
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.
| score on a scale | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Breast and Nipple Pain | 0 (0 to 0.75) | 0 (0 to 0) | 1 (0 to 2) |
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).
| score on a scale | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Severity of Breast Engorgement | 1 (1 to 2) | 1.5 (1 to 2) | 2 (1 to 3) |
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.
| units on a scale | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Breast Hardness | 5.2 (2.8 to 7.4) | 1.0 (0.2 to 5.9) | 2.3 (1.1 to 3.7) |
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.
| Degrees Celsius | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Body and Breast Temperature | 36.9 (36.7 to 37.3) | 36.7 (36.6 to 37.1) | 37.0 (36.7 to 37.4) |
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.
| g | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Volume of Mother's Milk | 52.2 (20.6 to 81.5) | 17.8 (2.6 to 35.3) | 40.7 (16.9 to 112.0) |
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.
| Participants | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Acceptability of the Intervention Program | 11 | 11 | 7 |
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.
| Participants | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Number of Participants Reporting Adverse Events | 0 | 0 | 0 |
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.
| score on a scale | Intervention Group | Sham Group | Usual Care Group |
|---|---|---|---|
| Breastfeeding Self-efficacy | 52.0 (40.0 to 58.0) | 59.5 (34.25 to 68.75) | 55 (52.5 to 59.5) |
Collected over 2 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Sham Group | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Usual Care Group | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | Intervention Group | Sham Group | Usual Care Group | Total |
|---|---|---|---|---|
| Mean | 34.5 ± 3.3 | 33.6 ± 3.7 | 34.2 ± 4.4 | 34.1 ± 3.7 |
| Sex/Gender, Customized(Participants) | Intervention Group | Sham Group | Usual Care Group | Total |
|---|---|---|---|---|
| Female | 12 | 12 | 13 | 37 |
| Race and Ethnicity Not Collected(Participants) | Intervention Group | Sham Group | Usual Care Group | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Body mass index(kg/m^2) | Intervention Group | Sham Group | Usual Care Group | Total |
|---|---|---|---|---|
| Mean | 24.6 ± 3.4 | 24.1 ± 3.7 | 24.0 ± 3.7 | 24.2 ± 3.5 |
| Waist-hip ratio(Ratio) | Intervention Group | Sham Group | Usual Care Group | Total |
|---|---|---|---|---|
| Mean | 0.83 ± 0.04 | 0.82 ± 0.06 | 0.82 ± 0.04 | 0.83 ± 0.04 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Apr 2023, 28 months.
Results were first posted in Jul 2024, 1 year 2 months after primary completion.
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