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Completed

NCT Number: NCT06352918

Peripheral Central Catheter (PICC) Care

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.

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Key information

Conditions

Newborn Acute Pain Neurologic Manifestations Pain Pain, Acute Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

The Effect of Palmar Grasp Reflex Stimulation on Pain and Comfort Level in Peripherally Inducted Central Catheter (PICC) Care in Preterm Babies

Acronym: PICC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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