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

17 augusti 2026 uppdaterad av: 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

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

100

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Uganda
      • Kampala, Uganda
        • Makerere University School of Public Health
        • Kontakt:
        • Huvudutredare:
          • Victoria Nankabirwa, PhD, MBBCh

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Relaxation Audiorecording
Listening to a relaxation audiorecording twice daily on a digital audio device while breastfeeding
Beteende: Relaxation audiorecording
This intervention will be an audiorecording on a digital audio device consisting of 15 minutes of relaxing messages supportive of breastfeeding.
Placebo-jämförare: Control audio device
Digital audio device without a relaxation audiorecording
Beteende: Control audio device without relaxation audiorecording
Participants in the control group will receive a digital audio device that does not have a relaxation audiorecording

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in weight-for-age z-score (WAZ)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Breastfeeding frequency
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of California, San Francisco

Samarbetspartners

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

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 maj 2027

Avslutad studie (Beräknad)

1 maj 2027

Studieregistreringsdatum

Först inskickad

12 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

17 augusti 2026

Första postat (Faktisk)

19 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

19 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 1R21HD117269 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

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NEJ

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