Gentle Human Touch and Stimulus Reduction for Pain and Comfort Management in Premature Newborns During Heel Blood Collection
This study aims to manage pain and improve comfort in premature newborns during heel blood collection, by using gentle human touch and stimulus reduction, with the primary outcomes being the assessment of procedural pain and comfort scores.
Gentle Human Touch
+ Environmental Modification
Urogenital Diseases+3
+ Female Urogenital Diseases and Pregnancy Complications
+ Obstetric Labor Complications
Supportive Care Study
Summary
Study start date: April 20, 2026
Actual date on which the first participant was enrolled.This study focuses on premature babies in the neonatal intensive care unit who often undergo painful procedures. The research aims to understand the effect of Gentle Human Touch (GHT) and sensory reduction (using an eye mask and earplug) on pain and comfort during heel prick blood collection. The study involves premature infants between 32-36+6 weeks of gestational age. The importance of this study lies in finding safe and effective non-medicinal ways to manage pain and improve care for these vulnerable newborns. In this trial, 60 infants are randomly assigned to three groups: GHT, sensory reduction, and standard care (using a pacifier). The pain experienced during the procedure is measured using the Premature Infant Pain Profile-Revised (PIPP-R) scale, which ranges from 0 to 21, with higher scores indicating more pain. Comfort levels are assessed before, during, and after the procedure using the COMFORTneo scale, which ranges from 7 to 35, with higher scores indicating less comfort. The study also records physiological impacts such as heart rate and oxygen saturation, as well as the time taken for the procedure.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
No InterventionStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location