Trial reportNursing open2026
The Effect of Maternal Lullaby Singing, Affectionate Touch, and a Developmental Support Program on Comfort and Development in Premature Infants: A Randomized Controlled Trial.
Trial report in Nursing open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06191757 (Effect Of Early Intervention Program Applied To Premature Infants In The Neonatal Intensive Care Unit On Comfort And Development), which is not on this map. Not yet cited in PubMed.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Effect Of Early Intervention Program Applied To Premature Infants In The Neonatal Intensive Care Unit On Comfort And Development
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Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimPremature infants require interventions supporting comfort in the NICU and development after discharge. Therefore, this study examined the effects of maternal affectionate touch and lullaby singing on early comfort and of a developmental support programme on subsequent development.
designThis randomized controlled experimental study included 57 premature infants in a neonatal intensive care unit: 27 in the intervention group and 30 in the control group.
methodsMothers in the intervention group provided lullaby singing and affectionate touch three times weekly for at least six 10-min sessions. From 40 weeks' gestation, they implemented the developmental support programme, and infant development was assessed monthly for 3 months. The Premature Infant Comfort Scale and Developmental Support Programme Evaluation Form were used.
resultsSex distribution was 8/19 girls/boys (29.6%/70.4%) in the intervention group and 16/14 (53.3%/46.7%) in the control group. Post-intervention PICS scores were significantly lower in the intervention group in weeks 1, 2, and 4 (p = 0.032, p < 0.001, and p = 0.047, respectively). At 1 month, social-emotional development (p = 0.028), receptive language (p = 0.005-0.009), productive language (p = 0.002), and cognitive skills (p = 0.004) were significantly higher in the intervention group. Receptive language at 2 months (p = 0.028) and cognitive development at 3 months (p = 0.033) also favoured the intervention group. In the BH-FDR sensitivity analysis, only the Week 2 post-intervention PICS difference (adjusted p = 0.012) and the first-month PLS-4 language finding (adjusted p = 0.040) remained statistically significant; the first-month RLS-3 finding was at the threshold of statistical significance (adjusted p = 0.050). RECOMMENDATIONS: Maternal lullaby singing, affectionate touch, and developmental support may support comfort and early developmental follow-up in premature infants; however, findings should be confirmed in larger studies with longer follow-up. PATIENT OR PUBLIC CONTRIBUTION: Mothers participated voluntarily and devoted sufficient time to each stage of the study.
trial registrationClinicalTrials.gov identifier: NCT06191757.
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