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Recruiting Not applicable

Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns

NCT07747649 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-04-01
Last updated
2026-08-05

Condition(s) studied

Procedural Pain in Newborns

Investigational drug(s) / intervention(s)

Multisensory Stimulation

Multisensory Stimulation: The multisensory stimulation intervention consists of four components: breastfeeding, gentle stroking, maternal singing or lullaby, and eye contact. Breastfeeding will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. During the same 15-minute period, the mother will gently stroke the newborn's leg from which the heel blood sample will be obtained. Throughout the heel blood sampling procedure, the mother will sing a lullaby or song in a soft and calm voice and maintain continuous eye contact with the newborn. No standardized song or lullaby will be prescribed, and the sound level will remain within the range of natural mother-newborn communication.

Study summary

This randomized controlled study will evaluate whether multisensory stimulation can reduce pain in healthy newborns during heel blood sampling. Newborns will be assigned to either a multisensory stimulation group, which includes breastfeeding, gentle stroking, maternal singing, and eye contact, or a control group in which the procedure will be performed while the newborn is held in the mother's arms. Pain scores, crying duration, heart rate, oxygen saturation, and procedure duration will be compared between the groups.

Eligibility

Sex
ALL
Min age
1 Day
Max age
28 Days
Healthy volunteers
Accepted
Inclusion Criteria: * Healthy newborns aged 0-28 days * Newborns receiving routine monitoring and care with their mothers in the hospital's newborn care unit * Written informed consent provided by the newborn's parent or legal representative Exclusion Criteria: * Presence of any lower-extremity anomaly * Ongoing monitoring or treatment in the neonatal intensive care unit * Presence of a congenital disease

Primary outcome measure(s)

  • N-PASS Pain Score — Immediately before, during, and immediately after heel blood sampling.
    Newborn pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS). The scale evaluates crying or irritability, behavioral state, facial expression, extremity tone or body tension, and changes in vital signs. Higher pain scores indicate greater pain or agitation.

Trial sites (2)

FacilityCityRegionStatus
Tatvan State Hospital Ankara Beşevler Recruiting
Bitlis State Hospita Bitlis Bitlis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07747649 on ClinicalTrials.gov ↗ ← All trials in Turkey