Trial Outcomes & Findings for Physical Therapy Intervention for Puerperal Mastitis (NCT NCT04569136)
NCT ID: NCT04569136
Last Updated: 2024-07-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
3 months
Results posted on
2024-07-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
13
|
|
Overall Study
COMPLETED
|
10
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.5 years
STANDARD_DEVIATION 3.3 • n=12 Participants
|
33.6 years
STANDARD_DEVIATION 3.7 • n=12 Participants
|
34.2 years
STANDARD_DEVIATION 4.4 • n=13 Participants
|
34.1 years
STANDARD_DEVIATION 3.7 • n=37 Participants
|
|
Sex/Gender, Customized
Female
|
12 Participants
n=12 Participants
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
37 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body mass index
|
24.6 kg/m^2
STANDARD_DEVIATION 3.4 • n=12 Participants
|
24.1 kg/m^2
STANDARD_DEVIATION 3.7 • n=12 Participants
|
24.0 kg/m^2
STANDARD_DEVIATION 3.7 • n=13 Participants
|
24.2 kg/m^2
STANDARD_DEVIATION 3.5 • n=37 Participants
|
|
Waist-hip ratio
|
0.83 Ratio
STANDARD_DEVIATION 0.04 • n=12 Participants
|
0.82 Ratio
STANDARD_DEVIATION 0.06 • n=12 Participants
|
0.82 Ratio
STANDARD_DEVIATION 0.04 • n=13 Participants
|
0.83 Ratio
STANDARD_DEVIATION 0.04 • n=37 Participants
|
PRIMARY outcome
Timeframe: 3 monthsBreast 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.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
|---|---|---|---|
|
Breast and Nipple Pain
|
0 score on a scale
Interval 0.0 to 0.75
|
0 score on a scale
Interval 0.0 to 0.0
|
1 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 3 monthsThe 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).
Outcome measures
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
|---|---|---|---|
|
Severity of Breast Engorgement
|
1 score on a scale
Interval 1.0 to 2.0
|
1.5 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 3.0
|
SECONDARY outcome
Timeframe: 3 monthsThe 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.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
|---|---|---|---|
|
Breast Hardness
|
5.2 units on a scale
Interval 2.8 to 7.4
|
1.0 units on a scale
Interval 0.2 to 5.9
|
2.3 units on a scale
Interval 1.1 to 3.7
|
SECONDARY outcome
Timeframe: 3 monthsCore 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.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
|---|---|---|---|
|
Body and Breast Temperature
|
36.9 Degrees Celsius
Interval 36.7 to 37.3
|
36.7 Degrees Celsius
Interval 36.6 to 37.1
|
37.0 Degrees Celsius
Interval 36.7 to 37.4
|
SECONDARY outcome
Timeframe: 3 monthsThe 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.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
|---|---|---|---|
|
Volume of Mother's Milk
|
52.2 g
Interval 20.6 to 81.5
|
17.8 g
Interval 2.6 to 35.3
|
40.7 g
Interval 16.9 to 112.0
|
SECONDARY outcome
Timeframe: 3 monthsAcceptability 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.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
|---|---|---|---|
|
Acceptability of the Intervention Program
|
11 Participants
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3 monthsAdverse 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.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
|---|---|---|---|
|
Number of Participants Reporting Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 monthsBreastfeeding 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.
Outcome measures
| Measure |
Intervention Group
n=12 Participants
* 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.
|
Sham Group
n=12 Participants
* 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.
|
Usual Care Group
n=13 Participants
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.
|
|---|---|---|---|
|
Breastfeeding Self-efficacy
|
52.0 score on a scale
Interval 40.0 to 58.0
|
59.5 score on a scale
Interval 34.25 to 68.75
|
55 score on a scale
Interval 52.5 to 59.5
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place