Peripheral Central Catheter (PICC) Care (PICC)

October 1, 2025 updated by: Türkan Kadiroğlu, Ataturk University

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reflex Stimulation
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.
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.
No Intervention: PICC Care
Without any intervention to the control group, the necessary data were recorded in accordance with the NICU's PICC care application procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comfort
Time Frame: 8 months
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.
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Estimated)

October 6, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • B.30.2.ATA.0.01.00/395

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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