About this trial
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 interventions in pain management and their inclusion in developmental care protocols.
Eligibility criteria
Qualifiers
Preterm infants with a gestational age between 32 and 36+6 weeks
Written informed consent obtained from parents
Disqualifiers
Infants with serious medical conditions that may affect study parameters
Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)
Trial design
Treatments tested in this trial
- Gentle Human Touch
- Environmental Modification
Treatment groups
Sponsors and collaborators
Kubra Nur Kabakcı Sarıdağ
Lead sponsor
Baskent University
Sponsor institution