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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age32-37
SponsorKubra Nur Kabakcı Sarıdağ

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

60 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Kubra Nur Kabakcı Sarıdağ

Lead sponsor

Baskent University

Sponsor institution