An interventional study of Relaxation audiorecording and Control audio device without relaxation audiorecording in Well-Being, Psychological, Breastfeeding and Low Birth Weight, sponsored by University of California, San Francisco. Recruiting at 1 site in Uganda. Open to participants aged 0 Days and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Prevention
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:
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:
Infant growth impairment is common in low-income countries and greatly increases the risk of adverse infant outcomes including infectious disease and cognitive impairment. Recently, randomized controlled trials in high-income countries have demonstrated that an audiorecording promoting relaxation during breastfeeding can improve growth for at-risk breastfeeding infants, perhaps by reducing maternal stress and improving maternal well-being. In this application, we propose to study whether such an intervention might be efficacious in a low-income country by conducting the randomized controlled trial, "Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)," which will enroll 100 mothers and their LBW newborns hospitalized in a high-stress setting in Uganda, randomly assign them either to an audiorecording promoting relaxation during breastfeeding (intervention) or to usual care (control), and follow them at 1, 2, 4, and 12 weeks after birth to assess infant growth, adverse events, milk intake, feeding behavior, and maternal wellbeing.
1,081 studies on the registry are indexed under Breast Feeding; 217 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 844 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
Compared within Breast Feeding, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Psychological Well-Being. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Listening to a relaxation audiorecording twice daily on a digital audio device while breastfeeding
Behavioral: Relaxation audiorecording
Digital audio device without a relaxation audiorecording
Behavioral: Control audio device without relaxation audiorecording
This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.
Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording
Change in weight-for-age z-score (WAZ)
Weight will be measured with the Seca 334 Infant Scale (Seca Inc., Wandsbek, Germany), which is portable for study visits at home or in hospital or clinic and is accurate to 5 grams. WAZ will be calculated from measured weight using the World Health Organization (WHO) Anthro Survey Analyser. Change in WAZ will be calculated by subtracting WAZ at birth from WAZ at 12 weeks of age.
Time frame: From birth through 12 weeks of age
Breastfeeding frequency
Breastfeeding behavior including frequency and duration will be assessed
Time frame: 1, 2, 4 and 12 weeks of age
Any infant dietary intake other than human milk since last study visit
Infant receipt of any feeding other than human milk since the last study visit will be assessed. We will query mothers about infant dietary intake since the last study visit including human breast milk, formula or any other feeding type such as juice or cow's milk. Infants who have received only human breast milk since the last study visit will be categorized as "no" for this outcome. Infants who have received any type of feeding other than human breast milk will be categorized as "yes" for this outcome.
Time frame: 1, 2, 4 and 12 weeks of age
Milk transfer
Milk transfer from mother to infant will be measured in grams using the Breast Milk Intake Function of the Seca 334 Infant Scale. We will subtract the infant's pre-feeding weight (measured in grams) from the infant's post-feeding weight (measured in grams) to determine grams of milk transferred from mother to infant during the feeding.
Time frame: 1, 2, 4 and 12 weeks of age
Maternal stress
Maternal stress will be measured at birth and at 4 and 12 weeks after birth using the Perceived Stress Scale (PSS), a tool which has been validated in the Ugandan postpartum population and which assesses participant stress over the past month. We will use the 10-item version of the PSS which has a minimum score of 0 and a maximum score of 40. Higher scores on the PSS are associated with increased stress.
Time frame: 1, 2, 4 and 12 weeks of age
Maternal anxiety
Maternal anxiety will be measured at birth and at 2, 4 and 12 weeks after birth using the Generalized Anxiety Disorder 7-item scale (GAD-7), which has been validated for use in the Uganda. The GAD-7 has a minimum score of 0 and a maximum score of 21, with higher scores indicating higher levels of anxiety. The GAD-7 assesses participant anxiety over the past two weeks, so we will assess mothers using the GAD-7 at intervals no more frequent than 2 weeks.
Time frame: 2, 4 and 12 weeks after birth
Maternal depression
Maternal depression will be measured at 1, 2, 4, and 12 weeks after birth using the Edinburgh Postnatal Depression Scale (EPDS). The minimum score on the EPDS is 0 and the maximum score is 30, with higher scores indicating increased risk of depression.
Time frame: 1, 2, 4, and 12 weeks after birth
sIgA
Secretory immunoglobulin A levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA)
Time frame: 2 and 4 weeks after birth
IgG
Immunoglobulin G levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA)
Time frame: 2 and 4 weeks after birth
Adverse events
Adverse events will be measured at 1, 2, 4 and 12 weeks after birth by querying participants regarding fever, difficulty feeding, difficulty breathing, cough, rash and diarrheal illness since the last study visit.
Time frame: 1, 2, 4 and 12 weeks after birth
Fingertip temperature
For participants in the intervention group, fingertip temperature will be measured with the Gentle Temp 720 Thermometer (Omron, Inc.) before and after listening to the audiorecording intervention at each study visit.
Time frame: 1, 2, 4 and 12 weeks after birth
Heart rate
For participants in the intervention group, heart rate will be measured with the BP7100 Series 3 (Omron, Inc.) before and after listening to the audiorecording intervention at each study visit.
Time frame: 1, 2, 4 and 12 weeks after birth
Blood pressure
For participants in the intervention group, blood pressure will be measured with the BP7100 Series 3 (Omron, Inc.) before and after listening to the audiorecording at each study visit.
Time frame: 1, 2, 4 and 12 weeks after birth
Actual use of the audiorecording
For participants in the intervention group, actual use of the audiorecording will be measured by self-report of how many times the audiorecording was used in the past 24 hours
Time frame: 1, 2, 4 and 12 weeks after enrollment
Plan to share: No
Started Aug 2026 (actual). Primary completion is estimated for May 2027, 9 months after the start.
Of 502 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 9 months is below that.
Counting every sponsor, half of 510 studies reached it within 12 months; a quarter within 6 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, San Francisco →