The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gentle Human Touch, Environmental Modification.
- Who it may be relevant to
- Registry conditions: Premature, Neonatal Intensive Care Unit, Touch, Nursing Care. Basic parameters: 32 Weeks — 37 Weeks · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Gentle Human Touch
Before starting the procedure, the nurse performing the intervention will wear a clean gown and wash both hands and forearms with an antimicrobial agent for 3 minutes. The nurse's hand temperature will be measured with a digital thermometer prior to the intervention to ensure it is at an appropriate level. If the temperature is not suitable, both hands will be warmed under a radiant warmer until they reach 33-33.2 °C, and the intervention will begin once this temperature is achieved. During th - Other Environmental Modification
Infants assigned to the environmental modification group will receive an eye mask and neonatal earmuffs (Minimuffs) to reduce exposure to light and noise. The eye mask is a soft, adjustable, and disposable phototherapy band designed to block external light stimuli. The earmuffs are oval-shaped, foam-based neonatal ear protectors with hydrogel adhesive, designed to reduce noise levels by more than 50% and ensure safe single use. Both interventions will be applied 3-5 minutes before, during, and f
Primary outcome measures
- Procedural Pain Score [Time frame: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.]
- Procedural Comfort Score [Time frame: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.]
Secondary outcome measures (2)
- Crying Duration [Time frame: During and immediately after heel prick blood sampling]
- Oxygen Saturation [Time frame: 5 minutes before, during, and 5 minutes after heel prick blood sampling]
Eligibility 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Turkey (Türkiye) · 1 center
- Etlik City Hospital — Ankara
Identifiers
NCT: NCT07715682 · KUBRAN-GHT-PREM-2025