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

NCT07715682 | Recruiting DMC

• 1 other identifier: KUBRAN-GHT-PREM-2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature; Neonatal Intensive Care Unit; Touch; Nursing Care

Outcome Measures

Primary Outcomes (2)

• Procedural Pain Score

  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.

  5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.

• Procedural Comfort Score

  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.

  5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.

Secondary Outcomes (2)

• Crying Duration

  During and immediately after heel prick blood sampling

• Oxygen Saturation

  5 minutes before, during, and 5 minutes after heel prick blood sampling

Study Arms (3)

Gentle Human Touch

EXPERIMENTAL

Gentle human touch (GHT) will be applied 3-5 minutes before, during, and after the heel prick blood test.

Other: Gentle Human Touch

Environmental Modification

EXPERIMENTAL

Eye mask and earmuffs will be applied 3-5 minutes before, during, and after the heel prick blood test.

Other: Environmental Modification

Standard Care

NO INTERVENTION

Finger feeding will be provided before, during, and after the procedure, according to the unit routine.

Interventions

Gentle Human Touch OTHER

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.

Gentle Human Touch

Environmental Modification OTHER

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.

Environmental Modification

Eligibility Criteria

• Age: 32 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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)

Sponsors & Collaborators

• Kubra Nur Kabakcı Sarıdağ: lead

Study Sites (1)

Etlik City Hospital

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Kubra Nur N KABAKCI SARIDAĞ, RN, MSc

CONTACT

+905079149033; kubranurkabakci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: July 20, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)