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The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns

RecruitingNAAges 32 Weeks - 37 WeeksAllKubra Nur Kabakcı Sarıdağ
NCT07715682 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Premature infants frequently experience painful procedures during their admission to neonatal intensive care units; this can lead to acute adverse events, imbalances, and long-term neurodevelopmental implications. This randomized controlled trial evaluates the impact of Gentle Human Touch (GHT) and rate change (eye mask and earplug) on pain and comfort during heel prick blood collection in premature infants (32-36+6 weeks gestational age). A total of 60 infants were randomly assigned to three groups: GHT, rate change, and standard care (pacifier). Pain was assessed using the Premature Infant Pain Profile-Revised (PIPP-R), and comfort was measured before, during, and after the procedure using the COMFORTneo operator. Physiological impact (heart rate, oxygen saturation) and propagation time were recorded. The findings provide evidence for safe and effective non-pharmacological intervention

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📋 Eligibility rules (as published)
Inclusion Criteria: * Preterm infants with a gestational age between 32 and 36+6 weeks * Written informed consent obtained from parents Exclusion Criteria: * Infants with serious medical conditions that may affect study parameters * Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)
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What it tests

  • Gentle Human Touch
  • Environmental Modification
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Where

1 site
Etlik City Hospital
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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