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RECRUITING Not applicable ClinicalTrials.gov

Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

Sponsor: University of California, San Francisco • ClinicalTrials.gov ID: NCT07774793

Registry updated: 2026-10-13
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Description

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

Interventions

  • Relaxation audiorecording (Behavioral)
    This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.
  • Control audio device without relaxation audiorecording (Behavioral)
    Participants in the control group will receive a digital audio device that does not have a relaxation 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

Conditions

Well-Being, Psychological Breastfeeding Low Birth Weight Undernutrition

Locations

  • Makerere University School of Public Health — Kampala, Uganda
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record