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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06352918
Other study ID # B.30.2.ATA.0.01.00/395
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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