Recruiting

Gentle Human Touch and Stimulus Reduction for Pain and Comfort Management in Premature Newborns During Heel Blood Collection

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Study Aim

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.

What is being tested

Gentle Human Touch

+ Environmental Modification

Other
Who is being recruted

Urogenital Diseases+3

+ Female Urogenital Diseases and Pregnancy Complications

+ Obstetric Labor Complications

+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorKubra Nur Kabakcı Sarıdağ
Study ContactKubra Nur N KABAKCI SARIDAĞ, RN, MScMore contacts
Last updated: July 20, 2026
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorKubra Nur Kabakcı Sarıdağ
Study ContactKubra Nur N KABAKCI SARIDAĞ, RN, MScMore contacts
Last updated: July 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsObstetric Labor ComplicationsObstetric Labor, PrematurePregnancy ComplicationsPremature Birth

Criteria

2 inclusion criteria required to participate
Written informed consent obtained from parents

Preterm infants with a gestational age between 32 and 36+6 weeks

2 exclusion criteria prevent from participating
Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)

Infants with serious medical conditions that may affect study parameters

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

No Intervention
Finger feeding will be provided before, during, and after the procedure, according to the unit routine.

Study 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

Recruiting

Etlik City Hospital

Ankara, Turkey (Türkiye)Open Etlik City Hospital in Google Maps
Recruiting
One Study Center