Peripheral Central Catheter (PICC) Care

Pain, Acute Clinical Trial

— PICC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06352918
• Other study ID #: B.30.2.ATA.0.01.00/395
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 31, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 28 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• NEWBORN
• Pain, Acute

Intervention

Other:
• Palmar grasp reflex stimulation
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.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	8 months