An interventional study of High dose music Exposure and Education in Pregnancy, sponsored by Chinese University of Hong Kong. Recruiting at 2 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Basic science
The goal of this randomized controlled study is to evaluate the effect of prenatal music exposure on infants through two years of age.
The study addresses two primary questions:
Participants will engage in music listening or self-learning five days a week until delivery. After the participants give birth, the children will be followed up on their neural responses to speech, as well as their language and cognitive development, until they reach two years of age.
The investigators will compare the effects of low- and high-dose prenatal music exposure with a control group receiving education and develop models to predict outcomes in fetuses exposed to prenatal music.
[BACKGROUND] Fetuses can hear in the womb from as early as 20 weeks of gestation. Research has shown that prenatal music and spoken language experiences are related to better neural and behavioral outcomes at birth. These findings, though focused on outcomes shortly after birth, are consistent with a larger body of research showing positive effects of postnatal music training on children's language and cognitive outcomes.
[AIM OF STUDY] Objective 1: To examine whether prenatal music exposure leads to better neural encoding of speech and better language and cognitive developmental outcomes up to two years of life.
Objective 2: To construct predictive models using fetal data (e.g., fetal brain MRI and ultrasound data, if available) to forecast individual differences in developmental outcomes among fetuses exposed to prenatal music.
[HYPOTHESIS] The investigators hypothesize that prenatal music exposure can strengthen a fetus's neural encoding of speech from birth, leading to better language and cognitive development in early childhood. The investigators further hypothesize that, despite the expected heterogeneity in intervention effects, fetal features can predict how much a fetus would benefit from prenatal music exposure.
243 studies on the registry are indexed under Language; 76 are open to participants now.
This study's planned enrollment of 480 is above the median of 65 across 158 interventional studies indexed under Language.
Browse Language studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Inclusion Criteria:
Participants will be exposed to a higher dose of music
Other: High dose music Exposure
Participants will be exposed to a lower dose of music
Other: Low dose music exposure
Participants will learn independently from educational materials
Other: Education
Participants will be exposed to children's songs in various languages for 40 minutes daily, five days per week, with 80% of songs presented at approximately 75 dB SPL and 20% at approximately 10 dB SPL.
Participants will learn independently from short educational videos and audios on pregnancy, maternal and child health, and parenting, five days a week.
Participants will be exposed to children's songs in various languages for 15 minutes daily, five days per week, with 20% of songs presented at approximately 75 dB SPL and 80% at approximately 10 dB SPL.
Neural encoding of speech as measured by EEG
Comparing the ability of neural encoding of speech as measured by EEG between groups.
Time frame: Birth to 1 month, and at 6, 12, and 24 months of age
Chinese Communicative Development Inventories (CCDI)
Comparing language and communicative abilities, as measured by the Chinese Communicative Development Inventories (CCDI), between groups.
Time frame: 12, and 24 months old
Bayley Scales of Infant and Toddler Development, 4th Edition (Bayley-4)
Five developmental domains (and subdomains): Cognitive, Language (Receptive and Expressive Communication subdomains), Motor (fine and gross motor subdomains), Social-emotional, and Adaptive Behavior will be assessed and compared across groups. The domain standard scores range from 45-155, and the subdomain scaled scores range from 1- 19 . Higher scores indicate better outcomes.
Time frame: 6, 12, and 24 months old
Change from baseline in stress score on the Perceived Stress Scale (PSS)
PSS stress score ranges from 0 to 40, with higher scores indicating higher perceived stress.
Time frame: From recruitment to 24 months old
Change from baseline in depression score on the Edinburgh Postnatal Depression Scale (EPDS)
The depression score ranges from 0 to 30, with a higher score indicating a high likelihood of depression.
Time frame: From recruitment to 12 months old
Change from baseline in maternal knowledge of child development on the 20-item short form of the Knowledge of Infant Development Inventory (KIDI) across groups
Total correct score ranges from 0- 20
Time frame: Recruitment and birth to 1 month old
Maternal sleep behavior measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: From recruitment to 24 months old
Brief Infant Sleep Questionnaire (BISQ)
Time frame: 6, 12, and 24 months old
Child development, emotion, and behavior measured by the Survey of Well-being of Young Children (SWYC)
Time frame: 6, 12, and 24 months old
Mother-infant attachment measured by the Postpartum Bonding Questionnaire (PBQ)
The PBQ score ranges from 0 to 125; the higher scores mean a poorer outcome.
Time frame: 0-1months, 6, and 12 months old
Plan to share: No
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