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

Recruiting now · Not applicable

Conditions studied: Premature, Neonatal Intensive Care Unit, Touch, Nursing Care

In brief

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.

Key facts

Study ID

NCT07715682

Run by

Kubra Nur Kabakcı Sarıdağ

People needed

60

Starts

2026-04-20

Expected to finish

2026-12-01

Last updated by the study team

2026-07-20

Who can join

Age: 1 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Preterm infants with a gestational age between 32 and 36+6 weeks
• Written informed consent obtained from parents

You may not qualify if…

• Infants with serious medical conditions that may affect study parameters
• Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)

Where it is running

• Etlik City Hospital — Ankara, Turkey (Türkiye) (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.