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

February 17, 2025 updated by: Chulalongkorn University

The Effects of Maternal Voice Listening Program on Preterm Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background & Rationale Premature infants in the Neonatal Intensive Care Unit (NICU) face significant developmental challenges due to maternal separation and environmental stressors, such as excessive noise, bright lights, and invasive medical procedures. These stressors can negatively affect biobehavioral responses, including sleep-wake patterns, motor activity, and physiological stability. Moreover, the absence of maternal presence in NICUs can impair the maternal-infant attachment process, which is crucial for emotional bonding and neurodevelopment.

The Structured Maternal Voice Program (SMVP) is an innovative intervention designed to address these challenges by exposing preterm infants to their mother's voice through pre-recorded audio messages. This program is based on existing evidence that supports the role of maternal voice in stabilizing neonatal responses, promoting sleep regulation, and enhancing attachment. However, limited research has been conducted on the structured implementation of maternal voice exposure in NICUs, especially in settings where maternal visitation is restricted.

This study aims to evaluate the effectiveness of the SMVP in improving premature infant biobehavioral responses and maternal-infant attachment in a NICU setting.

Study Objectives

The primary objectives of this study are to:

Evaluate the impact of SMVP on premature infant responses, including motor activity, behavioral states, and sleep-wake patterns.

Assess changes in maternal-infant attachment scores before and after exposure to SMVP.

Study Design This study is a quasi-experimental crossover trial conducted at the Queen Sirikit National Institute of Child Health (QSNICH), Bangkok, Thailand. The study is designed to minimize confounding variables using a crossover design involving two groups.

Participants: 16 mother-infant pairs (infants born at 32-36 weeks gestational age) Randomization: Infants are randomly assigned to either the experimental phase (SMVP first) or the control phase (standard nursing care first) Washout Period: A one-day washout period between crossover sequences to prevent residual effects from the initial phase Duration: The intervention lasts four consecutive days per phase Intervention Details

The Structured Maternal Voice Program (SMVP) involves playing pre-recorded maternal voice messages through an MP3 player integrated into the incubator. The voice recordings consist of:

Recognition messages: Short affirmations such as "I'm so glad to have you." Soothing messages: Longer comforting phrases such as "Rest well, little one, you're safe with me."

Playback schedule:

Three times daily (morning, afternoon, and evening) Five-minute duration per session Calibrated at 55-60 dB to mimic intrauterine auditory experiences The control group receives standard nursing care without maternal voice exposure during the initial phase. After the washout period, the groups switch interventions.

Outcome Measures

Primary Outcomes:

Infant motor activity: including single limb movement, gross body movement, and head movement Infant behavioral states: including active sleep and quiet alert

Secondary Outcome:

Maternal-Infant Attachment Score, measured using the Maternal-Infant Attachment Questionnaire Significance

The findings from this study may:

Provide empirical evidence supporting the use of maternal voice exposure in NICUs as a structured intervention.

Offer a non-invasive, cost-effective intervention that enhances preterm infant stability and development.

Contribute to the integration of maternal voice programs into routine NICU care to improve outcomes for preterm infants.

Serve as a model for addressing maternal-infant separation in settings with restricted hospital visitation, ensuring both emotional and developmental needs are met for preterm infants.

Study Type

Interventional

Enrollment (Actual)

16

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 Locations

  • Thailand
    • Patumwan
      • Bangkok, Patumwan, Thailand, 10330
        • Faculty of Nursing, Chulalongkorn University

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured Maternal Voice Program (SMVP)
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)
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.
Other: Standard Nursing Care
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Premature Infant Responses
Time Frame: Four days of intervention per phase

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal-Infant Attachment Score
Time Frame: Before and after the intervention phase (4 days per phase)
Maternal-infant attachment will be assessed before and after exposure to the Structured Maternal Voice Program (SMVP) using the Maternal-Infant Attachment Questionnaire (MIAQ). This validated tool measures maternal bonding and emotional connection with the infant, evaluating factors such as maternal sensitivity, affectionate behaviors, and perceived closeness. The questionnaire will be administered to mothers on Day 1 (pre-intervention) and Day 4 (post-intervention) of each phase. Statistical analyses will compare changes in attachment scores across conditions.
Before and after the intervention phase (4 days per phase)

Collaborators and Investigators

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

Sponsor

Chulalongkorn University

Collaborators

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

Investigators

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

Helpful Links

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 (Actual)

October 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC.097/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to ethical considerations and the sensitive nature of neonatal and maternal-infant attachment data, individual participant data (IPD) will not be shared publicly. However, aggregated and de-identified results will be published in peer-reviewed journals and presented at scientific conferences.

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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