Neonatal Intensive Care Unit, Nursing Care, Premature, Touch
Conditions
Brief summary
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
OTHERGentle 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 the intervention, the nurse will place the fingertips of one hand on the infant's eyebrow line with the palm resting on the top of the head, while the other hand will be positioned on the lower abdomen covering the waist and hips, maintaining this position for 15 minutes.
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 for 3-5 minutes after venous blood sampling, for a total of approximately 15 minutes. Standard care with a pacifier will also be provided according to unit practice.
Sponsors
Kubra Nur Kabakcı Sarıdağ
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 37 Weeks
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Pain Score | 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure. | The pain experienced during heel prick blood sampling will be assessed using the Premature Infant Pain Profile-Revised (PIPP-R) scale. The scale ranges from 0 to 21 (for premature infants), with higher scores indicating greater pain intensity. |
| Procedural Comfort Score | 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure. | Comfort during heel prick blood sampling will be assessed using the COMFORTneo Scale. The scale ranges from 7 to 35, with higher scores indicating a lower level of comfort. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crying Duration | During and immediately after heel prick blood sampling | Total duration of crying during heel prick blood sampling will be measured with a stopwatch and recorded in seconds. |
| Oxygen Saturation | 5 minutes before, during, and 5 minutes after heel prick blood sampling | Oxygen saturation levels will be monitored with pulse oximetry. |
Countries
Turkey (Türkiye)
Contacts
CONTACTKubra Nur N KABAKCI SARIDAĞ, RN, MSc
Outcome results
None listed