NCT07410949

Brief Summary

This randomized controlled trial evaluates whether acupressure education provided to mothers within the first 48 hours postpartum improves exclusive breastfeeding rates at 6 months compared with standard postpartum care alone. Mothers in the intervention group will receive structured education on self-administered acupressure at selected points and will be encouraged to continue home-based practice, while the control group will receive standard breastfeeding support. Participants will be followed for 12 months to assess breastfeeding continuation, breastfeeding self-efficacy, breastfeeding quality, and breastfeeding-related outcomes.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

February 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 15, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 7, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

AcupressurePostpartumExclusive breastfeedingBreastfeeding continuationBreastfeeding self-efficacy

Outcome Measures

Primary Outcomes (1)

  • Exclusive breastfeeding rate 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 Outcomes (7)

  • Any breastfeeding rate at 12 months postpartum

    At 12 months postpartum

  • Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) score

    Baseline (≤48 hours postpartum), 1, 3, 6, and 12 months postpartum

  • Breastfeeding quality score (LATCH)

    Baseline (≤48 hours postpartum) and 1 month postpartum

  • Maternal breastfeeding satisfaction score

    1 month, 3 months, 6 months, and 12 months postpartum

  • Time to introduction of complementary feeding

    From birth up to 12 months postpartum

  • +2 more secondary outcomes

Study Arms (2)

Acupressure Education Plus Standard Care

EXPERIMENTAL

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.

Other: Postpartum Acupressure Education Program

Standard Care Alone

NO INTERVENTION

Participants receive routine postpartum breastfeeding care and counseling according to institutional Baby-Friendly Hospital Initiative practices. No acupressure education, materials, or reminders are provided.

Interventions

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.

Acupressure Education Plus Standard Care

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University Hospital

Niğde, Merkez, 51240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Central Study Contacts

Pınar Erdoğan, Assoc. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors and the statistician will be blinded to group allocation.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This is a two-arm, parallel-group randomized controlled trial with individual allocation in a 1:1 ratio. Participants are randomized within 48 hours postpartum to receive either postpartum acupressure education in addition to standard breastfeeding care or standard breastfeeding care alone. There is no crossover between study arms, and all participants are followed prospectively for 12 months after delivery. Outcome assessors and the statistician are blinded to group allocation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

February 7, 2026

First Posted

February 13, 2026

Study Start

February 15, 2026

Primary Completion (Estimated)

February 15, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared publicly. Data will be stored in a de-identified format and used solely for the purposes of the present study and related publications, in accordance with institutional ethics approval.

Locations