MedTrace Logo

Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

NCT07774793 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-19

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if listening to a relaxation audiorecording during breastfeeding improves breastfeeding and infant outcomes and maternal well-being in a low-income country setting. The main questions it aims to answer are:

* Does listening to a relaxation audiorecording during breastfeeding improve infant growth?
* Does listening to a relaxation audiorecording during breastfeeding reduce maternal stress and anxiety?

Researchers will compare listening to an audiorecording on a digital recording device to receiving the digital recording device without an audiorecording to see if relaxation audiorecordings work to improve breastfeeding, infant growth and maternal well-being.

Participants will:

* Listen to an audiorecording twice daily while breastfeeding for 12 weeks
* Have study visits at 1, 2, 4 and 12 weeks for checkups and tests
* Let us know what they think of the audiorecording

Conditions

Interventions

BEHAVIORAL

Relaxation audiorecording

This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.

BEHAVIORAL

Control audio device without relaxation audiorecording

Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording

Sponsors & Collaborators

Principal Investigators

  • Valerie Flaherman, MD, MPH · University of California, San Francisco

  • Victoria Nankabirwa, PhD, MBBCh · Makerere University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
0 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-05-31
Completion
2027-05-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774793 on ClinicalTrials.gov