PrematureNCT07715682
The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns
A study testing Gentle Human Touch and Environmental Modification in people with Premature and Neonatal Intensive Care Unit, run by Kubra Nur Kabakcı Sarıdağ at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Premature, Neonatal Intensive Care Unit, Touch
- What is being tested?
- Gentle Human Touch and Environmental Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants with a gestational age between 32 and 36+6 weeks
- Written informed consent obtained from parents
Who cannot join
- Infants with serious medical conditions that may affect study parameters
- Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Etlik City Hospital
Ankara
Kübra S Kabakcı Sarıdağ, +90 5079149033, kubranurkabakci@gmail.com
About this study
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
- Being tested
- Gentle Human Touch, Environmental Modification
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentle Human TouchOther
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.
Environmental ModificationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Gentle Human Touch | Experimental | Gentle human touch (GHT) will be applied 3-5 minutes before, during, and after the heel prick blood test. Receives: 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. Receives: Other: Environmental Modification |
| Standard Care | No intervention | Finger feeding will be provided before, during, and after the procedure, according to the unit routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.
Secondary outcomes (2)
Crying Duration
Total duration of crying during heel prick blood sampling will be measured with a stopwatch and recorded in seconds.
Measured: During and immediately after heel prick blood sampling
Oxygen Saturation
Oxygen saturation levels will be monitored with pulse oximetry.
Measured: 5 minutes before, during, and 5 minutes after heel prick blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start20 Apr 2026
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kubra Nur Kabakcı Sarıdağ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kubra Nur Kabakcı Sarıdağ, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715682
- Sponsor's protocol ID
- KUBRAN-GHT-PREM-2025
- Status last verified
- Sep 2026
- First submitted
- 19 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gentle Human Touch and Stimulus Reduction on Pain and Comfort During Heel Blood Collection in Premature Newborns
- ClinicalTrials.gov ID
- NCT07715682
- Acronym / sponsor ID
- KUBRAN-GHT-PREM-2025
- Conditions
- Premature, Neonatal Intensive Care Unit, Touch, Nursing Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kubra Nur Kabakcı SarıdağUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gentle Human Touch | Experimental | Other: Gentle Human TouchGentle human touch (GHT) will be applied 3-5 minutes before, during, and after the heel prick blood test. |
| Environmental Modification | Experimental | Other: Environmental ModificationEye mask and earmuffs will be applied 3-5 minutes before, during, and after the heel prick blood test. |
| Standard Care | No intervention | –Finger feeding will be provided before, during, and after the procedure, according to the unit routine. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Preterm infants with a gestational age between 32 and 36+6 weeks
- Written informed consent obtained from parents
Key exclusion criteria (2 listed)
- Infants with serious medical conditions that may affect study parameters
- Infants receiving intensive invasive treatments (e.g., opioid or sedative medication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentle Human TouchBefore 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. | Other | Gentle Human Touch |
| Environmental ModificationInfants 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. | Other | Environmental Modification |
Primary outcome
Procedural Pain Score
Time frame: 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
Time frame: 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.
2 secondary outcomes
Crying Duration
Time frame: During and immediately after heel prick blood sampling
Oxygen Saturation
Time frame: 5 minutes before, during, and 5 minutes after heel prick blood sampling
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gentle Human Touch and Environmental Modification in people with Premature and Neonatal Intensive Care Unit, run by Kubra Nur Kabakcı Sarıdağ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubra Nur N KABAKCI SARIDAĞ, RN, MSc (+905079149033, kubranurkabakci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Pain Score (time frame: 5 minutes before the procedure, during the procedure, and 5 minutes after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.