NEWBORNPICCNCT06352918
Peripheral Central Catheter (PICC) Care
A study testing Palmar grasp reflex stimulation in people with NEWBORN and Pain, Acute, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes. Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- NEWBORN, Pain, Acute
- What is being tested?
- Palmar grasp reflex stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Without congenital defects,
- Not receiving sedation at least 3 hours before PICC care,
- No unexplained crying,
- Without neurological problems,
- Not undergoing surgical intervention,
- Babies with PICC insertion
Who cannot join
- Having had a painful procedure (invasive procedure, etc.) within the last hour,
- Babies for whom permission was not obtained from the parent through an informed voluntary consent form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Palmar Grasp Reflex Stimulation on Pain and Comfort Level in Peripherally Inducted Central Catheter (PICC) Care in Preterm Babies
Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.
Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies.
- Conditions
- NEWBORN, Pain, Acute
- Being tested
- Palmar grasp reflex stimulation
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmar grasp reflex stimulationOther
This initiative is stimulated by applying gentle pressure to the palm of the baby's palm while he or she is awake, lying on a flat surface in a symmetrical supine position.
| Study group | Role | What they receive |
|---|---|---|
| Reflex Stimulation | Experimental | Along with the NICU PICC care application procedures, palmar grasp reflex stimulation was performed on all babies by the same researcher, starting one minute before the procedure. Receives: Other: Palmar grasp reflex stimulation |
| PICC Care | No intervention | Without any intervention to the control group, the necessary data were recorded in accordance with the NICU's PICC care application procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
Premature Infant Pain Scale-Revision (PIPP-R): It is defined as the gestational age of preterm babies, change in heart rate, change in SPO2 level, initial behavioral state, frowning, squeezing eyes, nasolabial groove.
Measured: 8 months
Secondary outcomes (1)
Comfort
COMFORT neo: Consists of 7 sections: alertness, calmness/agitation, respiratory status, physical movements, muscle tone, facial expression and average heart rate. Each section has 5 items with 1 to 5 points. The cut-off point is 17 points on the comfort scale, with a minimum of 7 and a maximum of 35.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start1 May 2023
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NEWBORNStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Türkan Kadiroğlu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352918
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/395
- Acronym
- PICC
- Status last verified
- Oct 2025
- First submitted
- 3 Apr 2024
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Palmar Grasp Reflex Stimulation on Pain and Comfort Level in Peripherally Inducted Central Catheter (PICC) Care in Preterm Babies
- ClinicalTrials.gov ID
- NCT06352918
- Acronym / sponsor ID
- PICC / B.30.2.ATA.0.01.00/395
- Conditions
- NEWBORN, Pain, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 8 Apr 2024 (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.
Peripheral Central Catheter (PICC) is one of the painful interventions that are routinely performed repeatedly to establish a safe venous access in preterm babies.Nurses should reduce the pain of babies and ensure their comfort during interventions arising from the necessity of care processes.
Today, it is accepted that tactile stimuli, which have a pain-reducing effect on babies, should be used as a complementary treatment and care method. Palmar grasp reflex is one of the important tactile stimuli to reduce pain and provide comfort in babies. This research will be conducted to examine the effect of palmar grasp reflex stimulation on pain and comfort levels in PICC care in preterm babies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reflex Stimulation | Experimental | Other: Palmar grasp reflex stimulationAlong with the NICU PICC care application procedures, palmar grasp reflex stimulation was performed on all babies by the same researcher, starting one minute before the procedure. |
| PICC Care | No intervention | –Without any intervention to the control group, the necessary data were recorded in accordance with the NICU's PICC care application procedures. |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Without congenital defects,
- Not receiving sedation at least 3 hours before PICC care,
- No unexplained crying,
- Without neurological problems,
- Not undergoing surgical intervention,
Key exclusion criteria (2 listed)
- Having had a painful procedure (invasive procedure, etc.) within the last hour,
- Babies for whom permission was not obtained from the parent through an informed voluntary consent form
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 |
|---|---|---|
| Palmar grasp reflex stimulationThis initiative is stimulated by applying gentle pressure to the palm of the baby's palm while he or she is awake, lying on a flat surface in a symmetrical supine position. | Other | Reflex Stimulation |
Primary outcome
Pain level
Time frame: 8 months
Premature Infant Pain Scale-Revision (PIPP-R): It is defined as the gestational age of preterm babies, change in heart rate, change in SPO2 level, initial behavioral state, frowning, squeezing eyes, nasolabial groove.
1 secondary outcome
Comfort
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for NEWBORN
Active, not recruiting
Measuring Impact of Computer Gaming on Arm Use in Rett Syndrome
Rett Syndrome
RecruitingObservational study
Feasibility Study of a Chatbot AI-Driven Preliminary Screening System for Hereditary Cancer Syndromes
Hereditary Cancer Syndromes
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruitingPhase 3
Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair
Colon Adenocarcinoma, DNA Repair Disorder
Not yet recruitingPhase 2
Combination of Avutometinib and Defactinib for Treatment of Relapsed, Refractory, Metastatic, or Unresectable Malignant Peripheral Nerve Sheath Tumor
MPNST (Malignant Peripheral Nerve Sheath Tumor)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmar grasp reflex stimulation in people with NEWBORN and Pain, Acute, run by Ataturk University 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 6 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: finished, as of the sponsor's last update on 6 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 8 months). 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 6 Oct 2025.