- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07410949
Postpartum Acupressure Education and Breastfeeding Outcomes
Effect of Postpartum Acupressure Education on Breastfeeding Outcomes: A 12-Month Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Exclusive breastfeeding for the first 6 months and continued breastfeeding up to 12 months are strongly associated with improved maternal and infant health outcomes. Despite widespread implementation of Baby-Friendly Hospital Initiative practices, early postpartum challenges often compromise breastfeeding continuation. Scalable, low-cost, self-care-based interventions that enhance maternal confidence and perceived control may support sustained breastfeeding.
This study is a two-arm, parallel-group, randomized controlled trial designed to assess the effectiveness of postpartum acupressure education as an adjunct to standard breastfeeding care. Eligible mothers will be randomized in a 1:1 ratio to either an acupressure education plus standard care group or a standard care-only group. Acupressure education will include face-to-face instruction, printed visual materials, and a short instructional video, focusing on the acupoints CV17 (Shanzhong), ST18 (Rugen), SI1 (Shaoze), ST36 (Zusanli), and SP6 (Sanyinjiao).
The primary outcome is the rate of exclusive breastfeeding at 6 months postpartum, defined according to World Health Organization criteria. Secondary outcomes include any breastfeeding at 12 months, breastfeeding self-efficacy, breastfeeding quality, timing of complementary feeding introduction, breastfeeding-related adverse events, and maternal satisfaction. Analyses will be conducted using an intention-to-treat approach.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pınar Erdoğan, Assoc. Prof.
- Phone Number: +905233646954
- Email: drpinarerdogan@gmail.com
Study Locations
-
-
Merkez
-
Niğde, Merkez, Turkey (Türkiye), 51240
- Recruiting
- Niğde Ömer Halisdemir University Hospital
-
Contact:
- Pınar Erdoğan
- Phone Number: 05233646954
- Email: pinar.erdogan@ohu.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 to 45 years
- Term singleton birth (≥37 weeks of gestation)
- ≤48 hours postpartum at the time of enrollment
- Intention to breastfeed
- Ability to communicate in Turkish
- Access to a smartphone for educational materials and follow-up reminders
- Willingness to provide written informed consent
Exclusion Criteria:
- Contraindications to breastfeeding (e.g., infant galactosemia)
- Severe neonatal condition preventing breastfeeding
- Severe maternal medical or psychiatric condition interfering with breastfeeding
- Current opioid, alcohol, or substance dependence
- Multiple gestation pregnancy
- Severe breast injury or condition within the first 72 hours postpartum preventing breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupressure Education Plus Standard Care
Participants receive standard postpartum breastfeeding care in addition to structured education on self-administered acupressure.
Acupressure education is provided within 48 hours postpartum and includes face-to-face instruction, printed visual materials, and a short instructional video.
Participants are instructed to apply acupressure at the specified points twice daily at home throughout the postpartum period, according to the study protocol.
|
Structured education on self-administered acupressure provided within 48 hours postpartum, including face-to-face instruction, printed visual materials, and a short instructional video.
Participants are instructed to apply acupressure at specified points twice daily at home according to the study protocol.
|
|
No Intervention: Standard Care Alone
Participants receive routine postpartum breastfeeding care and counseling according to institutional Baby-Friendly Hospital Initiative practices.
No acupressure education, materials, or reminders are provided.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exclusive breastfeeding rate at 6 months postpartum
Time Frame: At 6 months postpartum
|
Proportion of participants exclusively breastfeeding at 6 months postpartum, assessed by maternal self-report using 24-hour recall with additional validation questions, consistent with World Health Organization definitions.
|
At 6 months postpartum
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Any breastfeeding rate at 12 months postpartum
Time Frame: At 12 months postpartum
|
Proportion of participants providing any breast milk at 12 months postpartum.
|
At 12 months postpartum
|
|
Maternal breastfeeding satisfaction score
Time Frame: 1 month, 3 months, 6 months, and 12 months postpartum
|
Maternal self-reported satisfaction with the breastfeeding experience, assessed using a single-item numeric rating scale ranging from 0 to 10, where higher scores indicate greater breastfeeding satisfaction.
|
1 month, 3 months, 6 months, and 12 months postpartum
|
|
Time to introduction of complementary feeding
Time Frame: From birth up to 12 months postpartum
|
Time from birth to first introduction of any food or liquid other than breast milk, as reported by the mother.
|
From birth up to 12 months postpartum
|
|
Bottle or pacifier use
Time Frame: 1 week, 1 month, 3 months, 6 months, 9 months, and 12 months postpartum
|
Maternal report of any bottle feeding and/or pacifier use by the infant.
|
1 week, 1 month, 3 months, 6 months, 9 months, and 12 months postpartum
|
|
Breastfeeding-related adverse events
Time Frame: From baseline through 12 months postpartum
|
Incidence of mastitis, plugged ducts, and breastfeeding-related healthcare visits.
|
From baseline through 12 months postpartum
|
|
Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) score
Time Frame: Baseline (≤48 hours postpartum), 1, 3, 6, and 12 months postpartum
|
Total score on the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF).
The scale consists of 14 items rated on a 5-point Likert scale (1-5), yielding a total score ranging from 14 to 70, with higher scores indicating greater breastfeeding self-efficacy.
|
Baseline (≤48 hours postpartum), 1, 3, 6, and 12 months postpartum
|
|
Breastfeeding quality score (LATCH)
Time Frame: Baseline (≤48 hours postpartum) and 1 month postpartum
|
Breastfeeding quality assessed using the LATCH breastfeeding assessment tool.
The LATCH score consists of 5 components (Latch, Audible swallowing, Type of nipple, Comfort, Hold), each rated from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate better breastfeeding performance.
|
Baseline (≤48 hours postpartum) and 1 month postpartum
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22504254-050.04-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Lactation
-
University of VirginiaUniversity of North CarolinaCompleted
-
Medela AGCompleted
-
Medela AGCompleted
-
Texas Tech University Health Sciences CenterTerminated
-
Oslo University HospitalCompleted
-
Chulalongkorn UniversityRecruiting
-
The Hospital for Sick ChildrenTerminated
-
Medela AGClinical Trial Unit, University Hospital Basel, SwitzerlandCompleted
-
Medical University of South CarolinaTraditional Medicinals CorporationCompletedLactationUnited States
Clinical Trials on Postpartum Acupressure Education Program
-
Sakarya UniversityNot yet recruitingBreastfeeding | Perceived Insufficient Milk Supply
-
University of MichiganCompleted
-
Ömercan AksoyCompletedPostpartum Hemorrhage | Simulation Based Medical Education | Obstetric CareTurkey (Türkiye)
-
Butler HospitalBrown University; Women and Infants Hospital of Rhode IslandCompletedPregnancy | Depressive SymptomsUnited States
-
Forgive AvorgbedorNot yet recruitingHigh Blood Pressure | Cardiovascular Disease Risk | Postpartum Hypertension | Hypertensive Disorders of PregnancyGhana
-
Centre Integre Universitaire de Sante et Services...Not yet recruiting
-
Taipei Medical UniversityCompletedSchizophrenia | ConstipationTaiwan
-
The Hong Kong Polytechnic UniversityUnknown
-
Ain Shams UniversityCompletedPostpartum DepressionEgypt
-
The Hong Kong Polytechnic UniversityCompletedKnee OsteoarthritisHong Kong