The Effects of Maternal Voice Listening Program on Preterm Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Chulalongkorn University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Premature Infant Responses
Study Overview
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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- — to 36 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Structured Maternal Voice Program (SMVP) (Behavioral)
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.
Intervention: Structured Maternal Voice Program (SMVP) (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Maternal-Infant Attachment Score(Before and after the intervention phase (4 days per phase))