NCT07774793 Relaxation Intervention to Improve Newborn Growth and Maternal Well-being
| NCT ID | NCT07774793 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Well-Being, Psychological |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-08-20 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-08-20 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Newborn low birth weight (LBW) (birth weight \< 2500 grams) * Newborn birth weight \>= 1800 g * Newborn admitted to Neonatal Intensive Care Unit (NICU) * Newborn in stable condition without WHO danger signs * Newborn age \<24 hours old * Breastfeeding initiated * Residence in the catchment area Exclusion Criteria: * Twins and other multiples * Newborn respiratory support or WHO danger signs * Newborn with major congenital anomaly or expected surgery * Contraindications to or unable to breastfeed * Mother with hearing impairment * Unable to speak Luganda
Contact & Investigator
Valerie Flaherman, MD, MPH
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT07774793 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, studying Well-Being, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07774793 currently recruiting?
Yes, NCT07774793 is actively recruiting participants. Contact the research team at victoria.laleau@ucsf.edu for enrollment information.
Where is the NCT07774793 trial being conducted?
This trial is being conducted at Kampala, Uganda.
Who is sponsoring the NCT07774793 clinical trial?
NCT07774793 is sponsored by University of California, San Francisco. The principal investigator is Valerie Flaherman, MD, MPH at University of California, San Francisco. The trial plans to enroll 100 participants.