Breast EngorgementNCT07561099
Auricular Therapy and Basic Care for Blocked Milk Ducts After Cesarean Delivery
A study testing Auricular Acupressure and Basic Breast Care in people with Breast Engorgement and Lactation Disorders, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to evaluate whether auricular acupressure combined with basic care can improve symptoms in postpartum women with blocked milk ducts after cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Breast Engorgement, Lactation Disorders
- What is being tested?
- Auricular Acupressure and Basic Breast Care
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteVietnam
- Study dates
- 1 May 2026to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Participants must meet all of the following criteria:
- Postpartum women aged 18-40 years who have undergone cesarean delivery and are hospitalized in the obstetrics department.
- At least 24 hours after cesarean delivery.
- Diagnosed with uncomplicated blocked milk ducts based on clinical signs, including localized breast pain and engorgement, a palpable localized firm mass, and reduced or interrupted milk flow.
- Absence of systemic signs of infection (e.g., fever ≥38.5°C, chills, or severe fatigue) and no evidence of breast abscess.
- Numeric Rating Scale (NRS) pain score ≥ 4.
- Gestational age ≥ 37 weeks, with a healthy newborn without abnormalities.
- Willing and able to provide written informed consent.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Clinical signs of mastitis, breast abscess, or breast infection.
- Underlying medical conditions that may affect lactation, such as diabetes mellitus, thyroid disorders, or chronic liver or kidney disease.
- Known allergy or hypersensitivity to materials used in auricular acupressure or components of basic breast care.
- Severe psychiatric or cognitive conditions that may impair the ability to follow study procedures.
- Inability or unwillingness to comply with the study protocol.
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Department of Obstetrics, Le Van Thinh Hospital
Ho Chi Minh City, Ho Chi Minh City
About this study
Official title: Effectiveness of Auricular Acupressure Combined With Basic Care for Blocked Milk Ducts After Cesarean Delivery: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether auricular acupressure combined with basic care can improve symptoms in postpartum women with blocked milk ducts after cesarean delivery. The main questions it aims to answer are:
- Does auricular acupressure combined with basic care reduce breast pain more effectively than basic care alone?
- Does the combined approach improve the severity of milk duct blockage compared with basic care alone?
- What adverse effects may occur in participants receiving auricular acupressure? Researchers will compare auricular acupressure combined with basic care to sham auricular acupressure plus basic care to determine whether the intervention provides additional benefits.
Read more
Participants will:
- Receive auricular acupressure (or sham auricular acupressure at non-therapeutic ear points) for 3 days.
- Be instructed to perform basic breast care under the supervision of midwives three times daily for 3 days.
- Record daily activities in monitoring forms, including breastfeeding times, and whether they performed warm compresses and breast massage.
Read the detailed description
This randomized, single-blind, controlled clinical trial aims to evaluate the effectiveness and safety of auricular acupressure combined with basic breast care in postpartum women with blocked milk ducts following cesarean delivery.
Participants who meet the eligibility criteria will be randomly assigned to either the intervention group (auricular acupressure plus basic breast care) or the control group (sham auricular acupressure plus basic breast care). Auricular acupressure will be applied using semi-permanent auricular pellets at therapeutic ear acupoints on the ear ipsilateral to the affected breast, while the control group will receive sham intervention at non-therapeutic points. Both groups will receive standardized basic breast care, including frequent breastfeeding or milk expression, breast massage during feeding, and warm compresses before feeding.
The intervention will be administered over 3 consecutive days. Participants will be instructed and supervised by trained midwives and will perform self-care during the study period. Outcomes will be assessed at baseline and daily during the intervention period.
The primary outcome is the change in breast pain score measured by the Numeric Rating Scale (NRS). Secondary outcomes include changes in the severity of blocked milk ducts, use of rescue analgesic medication, and incidence of adverse events.
This study is designed as a randomized controlled trial to evaluate the effectiveness of auricular acupressure combined with basic breast care in postpartum women with blocked milk ducts following cesarean delivery. The sample size was calculated based on the primary outcome of pain intensity measured using the Numeric Rating Scale (NRS). A between-group difference of 1.8 NRS points was considered clinically meaningful. Using a two-sided significance level of 0.05, a power of 80%, and an estimated standard deviation of 2.56, the minimum required sample size was 32 participants per group. After allowing for an anticipated attrition rate of 10%, a total of 72 participants were recruited and randomized equally to the intervention group (n = 36) and the control group (n = 36).
- Conditions
- Breast Engorgement, Lactation Disorders
- Being tested
- Auricular Acupressure, Sham Auricular Acupressure, Basic Breast Care
- Medical subject headings
- Lactation Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular AcupressureProcedure or surgery
Also called Auricular Therapy, Ear Acupressure, Auricular Pellets
Auricular acupressure involves stimulation of specific ear acupoints corresponding to body organs. In this study, semi-permanent auricular needles (auricular pellets) will be applied to 4 therapeutic acupoints: Breast AH11, Shenmen TF4, Endocrine CO18, Central Rim AT2-4 on the ear ipsilateral to the affected breast. Needles will be retained for 3 days to provide continuous stimulation. Participants will be prompted to gently press the points 3 times daily. All procedures will be performed by a licensed traditional medicine physician following standardized protocols.
Sham Auricular AcupressureProcedure or surgery
Also called Placebo Auricular Acupressure, Sham Ear Acupressure
Sham auricular acupressure will be performed using semi-permanent auricular needles applied to 4 non-therapeutic ear points: Wrist SF2, Jaw LO3, Urethra HX3, Outer Nose TF1-2) unrelated to the pathophysiology of blocked milk ducts. The procedure, duration (3 days), and participant instructions will be identical to the active intervention to maintain blinding. All procedures will be performed by a licensed traditional medicine physician.
Basic Breast CareBehavioural
Also called Standard Care, Breast Care
Standardized basic breast care includes frequent breastfeeding (at least 8 times per day or milk expression if needed), gentle breast massage during feeding, and warm compresses (40-42°C for 10 minutes before feeding). Participants will be instructed and supervised by trained midwives three times daily and perform self-care at other times. Adherence will be recorded using monitoring forms.
| Study group | Role | What they receive |
|---|---|---|
| Auricular Acupressure + Basic Care | Experimental | In addition to standard basic breast care, participants will receive ear acupressure treatment using ear acupressure beads applied to therapeutic points on the ear corresponding to the affected breast, for three consecutive days. Receives: Procedure: Auricular Acupressure; Behavioral: Basic Breast Care |
| Sham Auricular Acupressure + Basic Care | Sham comparator | Participants will receive sham auricular acupressure using auricular pellets applied to non-therapeutic ear points, along with the same standardized basic breast care, for 3 consecutive days. Receives: Procedure: Sham Auricular Acupressure; Behavioral: Basic Breast Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast pain score (Numeric Rating Scale, NRS)
Breast pain will be assessed using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Participants will be interviewed by investigators at each assessment point.
Measured: From baseline (T0) to Day 3 after intervention (T3), assessed daily at 9:00 AM
Secondary outcomes (3)
Severity of blocked milk ducts
Severity will be assessed based on the number and size of palpable breast lumps. The largest diameter (cm) will be measured, and severity will be classified into 5 levels:
0 = no lump;
- = one lump <3 cm;
- = one lump 3-<5 cm;
- = one lump ≥5 cm;
- = multiple lumps.
Measured: From baseline (T0) to Day 3 after intervention (T3), assessed daily
Amount of rescue analgesic use (paracetamol)
Participants may use paracetamol 500 mg when NRS ≥7, with a maximum dose of 3 tablets per day. The number of tablets used will be recorded.
Measured: From baseline (T0) to Day 3 after intervention (T3)
Incidence of adverse events related to the intervention
All adverse events (e.g., allergic reactions, ear infection, syncope) will be recorded throughout the study period.
Measured: From baseline (T0) to Day 3 after intervention (T3) and at any time during the study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 May 2026
- Primary completion30 May 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast EngorgementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Le Lam My Duyen, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561099
- Sponsor's protocol ID
- 607/DHYD-HDDD
- Status last verified
- Apr 2026
- First submitted
- 26 Apr 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kataria K, Srivastava A, Dhar A. Management of lactational mastitis and breast abscesses: review of current knowledge and practice. Indian J Surg. 2013 Dec;75(6):430-5. doi: 10.1007/s12262-012-0776-1. Epub 2012 Dec 12.
PubMed 24465097Abou-Dakn M, Richardt A, Schaefer-Graf U, Wockel A. Inflammatory Breast Diseases during Lactation: Milk Stasis, Puerperal Mastitis, Abscesses of the Breast, and Malignant Tumors - Current and Evidence-Based Strategies for Diagnosis and Therapy. Breast Care (Basel). 2010 Mar;5(1):33-37. doi: 10.1159/000272223. Epub 2010 Feb 16.
PubMed 22619640Boram L, Chan-Young K, Sun Haeng L. Effectiveness and safety of auriculotherapy for breastfeeding: a systematic review. J Tradit Chin Med. 2020 Oct;40(5):721-737. doi: 10.19852/j.cnki.jtcm.2020.05.002.
PubMed 33000573Han S, Kim B, Park H. Auricular Acupressure on Breast Pain Among Breastfeeding Mothers Receiving Gentle Hand Techniques: A Randomized, Single-Blind, Sham-Controlled Trial. J Hum Lact. 2024 May;40(2):248-258. doi: 10.1177/08903344241228545. Epub 2024 Feb 20.
PubMed 38379313Hill PD, Humenick SS. The occurrence of breast engorgement. J Hum Lact. 1994 Jun;10(2):79-86. doi: 10.1177/089033449401000212.
PubMed 7619260Yu J, Zhou J. [Effect of auricular point sticking on lactation of puerperant]. Zhongguo Zhen Jiu. 2012 Dec;32(12):1087-9. Chinese.
PubMed 23301475Spencer JP. Management of mastitis in breastfeeding women. Am Fam Physician. 2008 Sep 15;78(6):727-31.
PubMed 18819238Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.
PubMed 32944940Chen ML, Tan JY, Suen LK. Auricular therapy for lactation: A systematic review. Complement Ther Clin Pract. 2017 Nov;29:169-184. doi: 10.1016/j.ctcp.2017.09.006. Epub 2017 Sep 18.
PubMed 29122257Fang YW, Chen SF, Wang ML, Wang MH. Effects of traditional Chinese medicine-assisted intervention on improving postpartum lactation: A systematic review and meta-analysis. Heliyon. 2024 Mar 1;10(6):e27154. doi: 10.1016/j.heliyon.2024.e27154. eCollection 2024 Mar 30.
PubMed 38524574
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Auricular Acupressure Combined With Basic Care for Blocked Milk Ducts After Cesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07561099
- Acronym / sponsor ID
- 607/DHYD-HDDD
- Conditions
- Breast Engorgement, Lactation Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate whether auricular acupressure combined with basic care can improve symptoms in postpartum women with blocked milk ducts after cesarean delivery. The main questions it aims to answer are:
- Does auricular acupressure combined with basic care reduce breast pain more effectively than basic care alone?
- Does the combined approach improve the severity of milk duct blockage compared with basic care alone?
- What adverse effects may occur in participants receiving auricular acupressure? Researchers will compare auricular acupressure combined with basic care to sham auricular acupressure plus basic care to determine whether the intervention provides additional benefits.
Participants will:
- Receive auricular acupressure (or sham auricular acupressure at non-therapeutic ear points) for 3 days.
- Be instructed to perform basic breast care under the supervision of midwives three times daily for 3 days.
- Record daily activities in monitoring forms, including breastfeeding times, and whether they performed warm compresses and breast massage.
Detailed description
This randomized, single-blind, controlled clinical trial aims to evaluate the effectiveness and safety of auricular acupressure combined with basic breast care in postpartum women with blocked milk ducts following cesarean delivery.
Participants who meet the eligibility criteria will be randomly assigned to either the intervention group (auricular acupressure plus basic breast care) or the control group (sham auricular acupressure plus basic breast care). Auricular acupressure will be applied using semi-permanent auricular pellets at therapeutic ear acupoints on the ear ipsilateral to the affected breast, while the control group will receive sham intervention at non-therapeutic points. Both groups will receive standardized basic breast care, including frequent breastfeeding or milk expression, breast massage during feeding, and warm compresses before feeding.
The intervention will be administered over 3 consecutive days. Participants will be instructed and supervised by trained midwives and will perform self-care during the study period. Outcomes will be assessed at baseline and daily during the intervention period.
The primary outcome is the change in breast pain score measured by the Numeric Rating Scale (NRS). Secondary outcomes include changes in the severity of blocked milk ducts, use of rescue analgesic medication, and incidence of adverse events.
This study is designed as a randomized controlled trial to evaluate the effectiveness of auricular acupressure combined with basic breast care in postpartum women with blocked milk ducts following cesarean delivery. The sample size was calculated based on the primary outcome of pain intensity measured using the Numeric Rating Scale (NRS). A between-group difference of 1.8 NRS points was considered clinically meaningful. Using a two-sided significance level of 0.05, a power of 80%, and an estimated standard deviation of 2.56, the minimum required sample size was 32 participants per group. After allowing for an anticipated attrition rate of 10%, a total of 72 participants were recruited and randomized equally to the intervention group (n = 36) and the control group (n = 36).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular Acupressure + Basic Care | Experimental | Procedure: Auricular Acupressure, Behavioral: Basic Breast CareIn addition to standard basic breast care, participants will receive ear acupressure treatment using ear acupressure beads applied to therapeutic points on the ear corresponding to the affected breast, for three consecutive days. |
| Sham Auricular Acupressure + Basic Care | Sham comparator | Procedure: Sham Auricular Acupressure, Behavioral: Basic Breast CareParticipants will receive sham auricular acupressure using auricular pellets applied to non-therapeutic ear points, along with the same standardized basic breast care, for 3 consecutive days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Postpartum women aged 18-40 years who have undergone cesarean delivery and are hospitalized in the obstetrics department.
- At least 24 hours after cesarean delivery.
- Diagnosed with uncomplicated blocked milk ducts based on clinical signs, including localized breast pain and engorgement, a palpable localized firm mass, and reduced or interrupted milk flow.
- Absence of systemic signs of infection (e.g., fever ≥38.5°C, chills, or severe fatigue) and no evidence of breast abscess.
- Numeric Rating Scale (NRS) pain score ≥ 4.
Key exclusion criteria (6 listed)
- Clinical signs of mastitis, breast abscess, or breast infection.
- Underlying medical conditions that may affect lactation, such as diabetes mellitus, thyroid disorders, or chronic liver or kidney disease.
- Known allergy or hypersensitivity to materials used in auricular acupressure or components of basic breast care.
- Severe psychiatric or cognitive conditions that may impair the ability to follow study procedures.
- Inability or unwillingness to comply with the study protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular AcupressureAlso: Auricular Therapy, Ear Acupressure, Auricular PelletsAuricular acupressure involves stimulation of specific ear acupoints corresponding to body organs. In this study, semi-permanent auricular needles (auricular pellets) will be applied to 4 therapeutic acupoints: Breast AH11, Shenmen TF4, Endocrine CO18, Central Rim AT2-4 on the ear ipsilateral to the affected breast. Needles will be retained for 3 days to provide continuous stimulation. Participants will be prompted to gently press the points 3 times daily. All procedures will be performed by a licensed traditional medicine physician following standardized protocols. | Procedure or surgery | Auricular Acupressure + Basic Care |
| Sham Auricular AcupressureAlso: Placebo Auricular Acupressure, Sham Ear AcupressureSham auricular acupressure will be performed using semi-permanent auricular needles applied to 4 non-therapeutic ear points: Wrist SF2, Jaw LO3, Urethra HX3, Outer Nose TF1-2) unrelated to the pathophysiology of blocked milk ducts. The procedure, duration (3 days), and participant instructions will be identical to the active intervention to maintain blinding. All procedures will be performed by a licensed traditional medicine physician. | Procedure or surgery | Sham Auricular Acupressure + Basic Care |
| Basic Breast CareAlso: Standard Care, Breast CareStandardized basic breast care includes frequent breastfeeding (at least 8 times per day or milk expression if needed), gentle breast massage during feeding, and warm compresses (40-42°C for 10 minutes before feeding). Participants will be instructed and supervised by trained midwives three times daily and perform self-care at other times. Adherence will be recorded using monitoring forms. | Behavioural | Auricular Acupressure + Basic Care, Sham Auricular Acupressure + Basic Care |
Primary outcome
Change in breast pain score (Numeric Rating Scale, NRS)
Time frame: From baseline (T0) to Day 3 after intervention (T3), assessed daily at 9:00 AM
Breast pain will be assessed using a 0-10 Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain. Participants will be interviewed by investigators at each assessment point.
3 secondary outcomes
Severity of blocked milk ducts
Time frame: From baseline (T0) to Day 3 after intervention (T3), assessed daily
Amount of rescue analgesic use (paracetamol)
Time frame: From baseline (T0) to Day 3 after intervention (T3)
Incidence of adverse events related to the intervention
Time frame: From baseline (T0) to Day 3 after intervention (T3) and at any time during the study period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 24465097Kataria K, Srivastava A, Dhar A. Management of lactational mastitis and breast abscesses: review of current knowledge and practice. Indian J Surg. 2013 Dec;75(6):430-5. doi: 10.1007/s12262-012-0776-1. Epub 2012 Dec 12.
- Background: PubMed 22619640Abou-Dakn M, Richardt A, Schaefer-Graf U, Wockel A. Inflammatory Breast Diseases during Lactation: Milk Stasis, Puerperal Mastitis, Abscesses of the Breast, and Malignant Tumors - Current and Evidence-Based Strategies for Diagnosis and Therapy. Breast Care (Basel). 2010 Mar;5(1):33-37. doi: 10.1159/000272223. Epub 2010 Feb 16.
- Background: PubMed 33000573Boram L, Chan-Young K, Sun Haeng L. Effectiveness and safety of auriculotherapy for breastfeeding: a systematic review. J Tradit Chin Med. 2020 Oct;40(5):721-737. doi: 10.19852/j.cnki.jtcm.2020.05.002.
- Background: PubMed 38379313Han S, Kim B, Park H. Auricular Acupressure on Breast Pain Among Breastfeeding Mothers Receiving Gentle Hand Techniques: A Randomized, Single-Blind, Sham-Controlled Trial. J Hum Lact. 2024 May;40(2):248-258. doi: 10.1177/08903344241228545. Epub 2024 Feb 20.
- Background: PubMed 7619260Hill PD, Humenick SS. The occurrence of breast engorgement. J Hum Lact. 1994 Jun;10(2):79-86. doi: 10.1177/089033449401000212.
- Background: PubMed 23301475Yu J, Zhou J. [Effect of auricular point sticking on lactation of puerperant]. Zhongguo Zhen Jiu. 2012 Dec;32(12):1087-9. Chinese.
- Background: PubMed 18819238Spencer JP. Management of mastitis in breastfeeding women. Am Fam Physician. 2008 Sep 15;78(6):727-31.
- Background: PubMed 32944940Zakarija-Grkovic I, Stewart F. Treatments for breast engorgement during lactation. Cochrane Database Syst Rev. 2020 Sep 18;9(9):CD006946. doi: 10.1002/14651858.CD006946.pub4.
- Background: PubMed 29122257Chen ML, Tan JY, Suen LK. Auricular therapy for lactation: A systematic review. Complement Ther Clin Pract. 2017 Nov;29:169-184. doi: 10.1016/j.ctcp.2017.09.006. Epub 2017 Sep 18.
- Background: PubMed 38524574Fang YW, Chen SF, Wang ML, Wang MH. Effects of traditional Chinese medicine-assisted intervention on improving postpartum lactation: A systematic review and meta-analysis. Heliyon. 2024 Mar 1;10(6):e27154. doi: 10.1016/j.heliyon.2024.e27154. eCollection 2024 Mar 30.
- Treatment of disorders of breastfeeding by auriculotherapy: Case reportLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Acupressure and Basic Breast Care in people with Breast Engorgement and Lactation Disorders, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in breast pain score (Numeric Rating Scale, NRS) (time frame: From baseline (T0) to Day 3 after intervention (T3), assessed daily at 9:00 AM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561099, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.