Mastitis
Conditions
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.
Interventions
OTHEREducation
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.
OTHERTherapeutic 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.
OTHERSham ultrasound
Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.
OTHERBreast 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.
OTHERUsual obstetric care
Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff.
Sponsors
Ministry of Science and Technology, Taiwan
National Cheng Kung University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group * Educating the patient about mastitis and self-management strategies
* Treating with therapeutic ultrasound
* Administering and teaching breast massage
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.
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.
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. | 12 |
| Sham Group * Educating the patient about mastitis and self-management strategies
* Receiving sham ultrasound
* Administering and teaching breast massage
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.
Sham ultrasound: Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.
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. | 12 |
| 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
Usual obstetric care: Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff. | 13 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 | 1 |
Baseline characteristics
| Characteristic | Intervention Group | Sham Group | Usual Care Group | Total |
|---|---|---|---|---|
| Age, Continuous | 34.5 years STANDARD_DEVIATION 3.3 | 33.6 years STANDARD_DEVIATION 3.7 | 34.2 years STANDARD_DEVIATION 4.4 | 34.1 years STANDARD_DEVIATION 3.7 |
| Body mass index | 24.6 kg/m^2 STANDARD_DEVIATION 3.4 | 24.1 kg/m^2 STANDARD_DEVIATION 3.7 | 24.0 kg/m^2 STANDARD_DEVIATION 3.7 | 24.2 kg/m^2 STANDARD_DEVIATION 3.5 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex/Gender, Customized Female | 12 Participants | 12 Participants | 13 Participants | 37 Participants |
| Waist-hip ratio | 0.83 Ratio STANDARD_DEVIATION 0.04 | 0.82 Ratio STANDARD_DEVIATION 0.06 | 0.82 Ratio STANDARD_DEVIATION 0.04 | 0.83 Ratio STANDARD_DEVIATION 0.04 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 | 0 / 13 |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 13 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 13 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Breast and Nipple Pain | 0 score on a scale |
| Sham Group | Breast and Nipple Pain | 0 score on a scale |
| Usual Care Group | Breast and Nipple Pain | 1 score on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Acceptability of the Intervention Program | 11 Participants |
| Sham Group | Acceptability of the Intervention Program | 11 Participants |
| Usual Care Group | Acceptability of the Intervention Program | 7 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Body and Breast Temperature | 36.9 Degrees Celsius |
| Sham Group | Body and Breast Temperature | 36.7 Degrees Celsius |
| Usual Care Group | Body and Breast Temperature | 37.0 Degrees Celsius |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Breastfeeding Self-efficacy | 52.0 score on a scale |
| Sham Group | Breastfeeding Self-efficacy | 59.5 score on a scale |
| Usual Care Group | Breastfeeding Self-efficacy | 55 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Breast Hardness | 5.2 units on a scale |
| Sham Group | Breast Hardness | 1.0 units on a scale |
| Usual Care Group | Breast Hardness | 2.3 units on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention Group | Number of Participants Reporting Adverse Events | 0 Participants |
| Sham Group | Number of Participants Reporting Adverse Events | 0 Participants |
| Usual Care Group | Number of Participants Reporting Adverse Events | 0 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Severity of Breast Engorgement | 1 score on a scale |
| Sham Group | Severity of Breast Engorgement | 1.5 score on a scale |
| Usual Care Group | Severity of Breast Engorgement | 2 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention Group | Volume of Mother's Milk | 52.2 g |
| Sham Group | Volume of Mother's Milk | 17.8 g |
| Usual Care Group | Volume of Mother's Milk | 40.7 g |