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

NCT06839534 | Completed DMC

• 1 other identifier: REC.097/2024
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Premature Infants; Neonatal Intensive Care Unit; Maternal-Infant Attachment; Infant Behavioral Responses; Maternal Voice

Outcome Measures

Primary Outcomes (1)

• Premature Infant Responses

  Premature infant responses, including motor activity and behavioral states, will be assessed before, during, and after exposure to the Structured Maternal Voice Program (SMVP). The assessment will include: * Motor Activity: Single limb movement, gross body movement, head movement * Behavioral States: Active sleep, quiet alert Observations will be conducted by trained NICU nurses using a standardized Infant Response Assessment Tool. Responses will be recorded during each intervention phase and analyzed using repeated measures analysis.

  Four days of intervention per phase

Secondary Outcomes (1)

• Maternal-Infant Attachment Score

  Before and after the intervention phase (4 days per phase)

Study Arms (2)

Structured Maternal Voice Program (SMVP)

EXPERIMENTAL

Participants in this group receive the Structured Maternal Voice Program (SMVP) for four days, followed by standard nursing care for four days after a one-day washout period.

Behavioral: Structured Maternal Voice Program (SMVP)

Standard Nursing Care

OTHER

Participants in this group receive standard nursing care for four days, followed by the Structured Maternal Voice Program (SMVP) for four days after a one-day washout period.

Behavioral: Structured Maternal Voice Program (SMVP)

Interventions

Structured Maternal Voice Program (SMVP) BEHAVIORAL

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.

Standard Nursing Care; Structured Maternal Voice Program (SMVP)

Eligibility Criteria

• Age: Up to 36 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born at 32-36 weeks gestational age
• Receiving care in the Neonatal Intensive Care Unit (NICU) at QSNICH
• Stable vital signs with no severe medical complications that would interfere with auditory perception
• Mothers willing and able to provide pre-recorded voice messages for SMVP
• Parental informed consent obtained

You may not qualify if:

• Critically unstable infants with severe medical complications (e.g., respiratory failure, severe metabolic acidosis)
• Infants with diagnosed auditory or neurological impairments affecting response to maternal voice
• Infants with severe intraventricular hemorrhage (Grade III or higher)
• Mothers unable to provide pre-recorded voice messages due to health or psychological limitations
• Families declining participation or withdrawing consent

Sponsors & Collaborators

• Chulalongkorn University: lead
• Queen Sirikit National Institute of Child Health (QSNICH), Thailand: collaborator

Study Sites (1)

Faculty of Nursing, Chulalongkorn University

Bangkok, Patumwan, 10330, Thailand

Location

Related Publications (1)

• Filippa M, Panza C, Ferrari F, Frassoldati R, Kuhn P, Balduzzi S, D'Amico R. Systematic review of maternal voice interventions demonstrates increased stability in preterm infants. Acta Paediatr. 2017 Aug;106(8):1220-1229. doi: 10.1111/apa.13832. Epub 2017 Apr 19.

  PMID: 28378337 BACKGROUND

Related Links

• Institutional Review Board (IRB) of Queen Sirikit National Institute of Child Health (QSNICH): Ethical approval and research guidelines.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

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

  Faculty of Nursing, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study uses a quasi-experimental crossover design to evaluate the effects of the Structured Maternal Voice Program (SMVP) on premature infant responses and maternal-infant attachment. Participants are randomly assigned to two sequences: (1) SMVP intervention followed by standard nursing care, or (2) standard nursing care followed by SMVP intervention. A one-day washout period is included between crossover phases to minimize residual effects.

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 21, 2025
• Study Start: October 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)