Clinical trial Recruiting at 1 site Interventional Ages 32 Weeks to 37 Weeks

Gentle Touch and Sensory Changes to Ease Heel Pricks in Preterm Babies

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

Run by Baskent University · NCT07715682 · Data updated 2026-11-12

This study tests whether gentle human touch or a quiet, reduced-stimulation environment can reduce pain and improve comfort during heel blood collection for premature infants.

Quick facts

Study typeInterventional
Ages32 Weeks to 37 Weeks
SexAll
Enrollment60 (estimated)
SponsorBaskent University
Academic / other
Locations1 site (Ankara)
StatusRecruiting
StartedApril 20, 2026
Main results expectedSeptember 2026
Study endsDecember 2026
Registry record updatedSeptember 16, 2026
Trial IDNCT07715682 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Preterm infants born at 32 to 36 weeks gestation whose parents provide written informed consent and who are not receiving invasive analgesic medications or with conditions that could affect study parameters.

Probably not a fit

Infants with serious medical conditions or those on intensive invasive treatments, including opioids or sedatives, may not benefit from these interventions.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial assigns 60 preterm infants (32 to 36+6 weeks gestational age) to one of three groups: Gentle Human Touch, environmental modification with eye mask and earplugs, or standard care using a pacifier. Pain is measured with the Premature Infant Pain Profile-Revised (PIPP-R) and comfort with the COMFORTneo during and after the heel prick, while also recording heart rate and oxygen saturation. The goal is to determine if non-pharmacological approaches can safely lessen procedural pain and improve comfort, potentially informing neonatal developmental care protocols. The study is conducted at Etlik City Hospital in Ankara and led by Kubra Nur Kabakcı Sarıdağ.

Why it matters

Potential benefit: If effective, these non-drug strategies could reduce pain and stress during routine heel pricks for preterm infants and be integrated into standard neonatal care.

How similar studies have gone: Previous non-pharmacologic approaches to neonatal pain have shown potential benefits, but this specific combination of gentle touch and rate-change environmental modification in heel-prick procedures is investigational in this setting.

Who can join: the full rules

Show full inclusion / exclusion criteria
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)

Where it's running

  • Etlik City Hospital
    Ankara, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.