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

Обзор

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• Procedural Pain Score [Срок оценки: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.]
• Procedural Comfort Score [Срок оценки: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.]

Вторичные конечные точки (2)

• Crying Duration [Срок оценки: During and immediately after heel prick blood sampling]
• Oxygen Saturation [Срок оценки: 5 minutes before, during, and 5 minutes after heel prick blood sampling]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Etlik City Hospital — Ankara

Идентификаторы

NCT: NCT07715682 · KUBRAN-GHT-PREM-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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