Relaxation Intervention to Improve Newborn Growth and Maternal Well-being (RING-MW)

August 17, 2026 updated by: University of California, San Francisco

Randomized Controlled Trial of a Relaxation Intervention to Improve Newborn Growth and Maternal Well-being

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Uganda
      • Kampala, Uganda
        • Makerere University School of Public Health
        • Contact:
        • Principal Investigator:
          • Victoria Nankabirwa, PhD, MBBCh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Relaxation Audiorecording
Listening to a relaxation audiorecording twice daily on a digital audio device while breastfeeding
Behavioral: Relaxation audiorecording
This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.
Placebo Comparator: Control audio device
Digital audio device without a relaxation audiorecording
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight-for-age z-score (WAZ)
Time Frame: From birth through 12 weeks of age
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.
From birth through 12 weeks of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breastfeeding frequency
Time Frame: 1, 2, 4 and 12 weeks of age
Breastfeeding behavior including frequency and duration will be assessed
1, 2, 4 and 12 weeks of age
Any infant dietary intake other than human milk since last study visit
Time Frame: 1, 2, 4 and 12 weeks of age
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.
1, 2, 4 and 12 weeks of age
Milk transfer
Time Frame: 1, 2, 4 and 12 weeks of age
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.
1, 2, 4 and 12 weeks of age
Maternal stress
Time Frame: 1, 2, 4 and 12 weeks of age
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.
1, 2, 4 and 12 weeks of age
Maternal anxiety
Time Frame: 2, 4 and 12 weeks after birth
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.
2, 4 and 12 weeks after birth
Maternal depression
Time Frame: 1, 2, 4, and 12 weeks after birth
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.
1, 2, 4, and 12 weeks after birth
sIgA
Time Frame: 2 and 4 weeks after birth
Secretory immunoglobulin A levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA)
2 and 4 weeks after birth
IgG
Time Frame: 2 and 4 weeks after birth
Immunoglobulin G levels in breast milk will be assessed with enzyme-linked immunosorbent assay (ELISA)
2 and 4 weeks after birth
Adverse events
Time Frame: 1, 2, 4 and 12 weeks after birth
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.
1, 2, 4 and 12 weeks after birth
Fingertip temperature
Time Frame: 1, 2, 4 and 12 weeks after birth
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.
1, 2, 4 and 12 weeks after birth
Heart rate
Time Frame: 1, 2, 4 and 12 weeks after birth
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.
1, 2, 4 and 12 weeks after birth
Blood pressure
Time Frame: 1, 2, 4 and 12 weeks after birth
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.
1, 2, 4 and 12 weeks after birth
Actual use of the audiorecording
Time Frame: 1, 2, 4 and 12 weeks after enrollment
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
1, 2, 4 and 12 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Makerere University
Cornell University

Investigators

  • Principal Investigator: Valerie Flaherman, MD, MPH, University of California, San Francisco
  • Principal Investigator: Victoria Nankabirwa, PhD, MBBCh, Makerere University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 12, 2026

First Submitted That Met QC Criteria

August 17, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21HD117269 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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