Neonatal Intensive Care UnitSMVP-NICUNCT06839534
Effects of a Structured Maternal Voice Program on Premature Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit
A study testing Structured Maternal Voice Program (SMVP) in people with Neonatal Intensive Care Unit and PreTerm Neonate, run by Chulalongkorn University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Intensive Care Unit, PreTerm Neonate, Healthy
- What is being tested?
- Structured Maternal Voice Program (SMVP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2023to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Nursing, Chulalongkorn University
Bangkok, Patumwan, 10330
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Intensive Care Unit, PreTerm Neonate, Healthy
- Being tested
- Structured Maternal Voice Program (SMVP)
- Keywords
- Premature Infants, Neonatal Intensive Care Unit, Maternal-Infant Attachment, Infant Behavioral Responses, Maternal Voice
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Maternal Voice Program (SMVP)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Structured Maternal Voice Program (SMVP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Four days of intervention per phase
Secondary outcomes (1)
Maternal-Infant Attachment Score
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.
Measured: Before and after the intervention phase (4 days per phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start1 Oct 2023
- Primary completion1 Sep 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Intensive Care UnitStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Sirikit National Institute of Child Health (QSNICH), Thailand
- Responsible party
- Sponsor
- Investigators
- Surasak Treenai Faculty of Nursing, Chulalongkorn University, Ph.D., Nursing, Principal investigator, Faculty of Nursing, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839534
- Sponsor's protocol ID
- REC.097/2024
- Acronym
- SMVP-NICU
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 28378337
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Maternal Voice Listening Program on Preterm Infant Responses and Maternal-Infant Attachment in the Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06839534
- Acronym / sponsor ID
- SMVP-NICU / REC.097/2024
- Conditions
- Neonatal Intensive Care Unit, PreTerm Neonate, Healthy
- Keywords
- Premature Infants, Neonatal Intensive Care Unit, Maternal-Infant Attachment, Infant Behavioral Responses, Maternal Voice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- Queen Sirikit National Institute of Child Health (QSNICH), Thailand
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Structured Maternal Voice Program (SMVP) | Experimental | Behavioral: 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. |
| Standard Nursing Care | Other | Behavioral: Structured Maternal Voice Program (SMVP)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. |
Who may qualify
- Ages
- Up to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Standard Nursing Care, Structured Maternal Voice Program (SMVP) |
Primary outcome
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.
1 secondary outcome
Maternal-Infant Attachment Score
Time frame: Before and after the intervention phase (4 days per phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Background: PubMed 28378337Filippa 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.
- Institutional Review Board (IRB) of Queen Sirikit National Institute of Child Health (QSNICH): Ethical approval and research guidelines.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Surasak Treenai Faculty of Nursing, Chulalongkorn University, Ph.D., Nursing principal investigator
Faculty of Nursing, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Maternal Voice Program (SMVP) in people with Neonatal Intensive Care Unit and PreTerm Neonate, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premature Infant Responses (time frame: Four days of intervention per phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06839534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.