Peripheral Central Catheter (PICC) Care

NCT06352918 | Completed

• 1 other identifier: B.30.2.ATA.0.01.00/395
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  8 months

Secondary Outcomes (1)

• Comfort

  8 months

Study Arms (2)

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.

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.

Interventions

Palmar grasp reflex stimulation OTHER

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.

Reflex Stimulation

Eligibility Criteria

• Age: 28 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investıgator

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 8, 2024
• Study Start: May 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)