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Effects of a Structured Maternal Voice Program on Premature Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit

NCT06839534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2025-02-21

No results posted yet for this study

Summary

This study evaluates the effects of a Structured Maternal Voice Program (SMVP). on premature infant responses and maternal-infant attachment in the intensive care unit (NICU) . Using a quasi-experimental crossover design, 16 mother-infant pairs (gestational age 32-36 weeks) were randomly assigned to experimental or control phases, with a four-day intervention and a one-day washout period. Infant responses and attachment outcomes were assessed using validated tools. Findings indicate significant improvements in motor activity, sleep states, and maternal-infant attachment scores, supporting the integration of maternal voice interventions in neonatal care.

Conditions

  • Neonatal Intensive Care Unit
  • PreTerm Neonate
  • Healthy

Interventions

BEHAVIORAL

Structured Maternal Voice Program (SMVP)

Pre-recorded maternal voice messages played via an MP3 player integrated into the infant's incubator. The recordings include recognition messages ("I'm so glad to have you") and soothing messages ("Rest well, little one, you're safe with me"). The intervention is delivered three times daily for five minutes per session over a four-day period.

Sponsors & Collaborators

  • Queen Sirikit National Institute of Child Health (QSNICH), Thailand

    collaborator UNKNOWN

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Surasak Treenai Faculty of Nursing, Chulalongkorn University, Ph.D., Nursing · Faculty of Nursing, Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-01
Primary Completion
2024-09-01
Completion
2024-12-01

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06839534 on ClinicalTrials.gov