Peripheral Intravenous Central Catheter Intervention in Preterm Infants

Not Applicable

Completed

• Conditions: Pain, Acute; Nursing Caries; Preterm; Stress
• Interventions: Behavioral: Graspin Palmar Reflex Stimulation

• Registration Number: NCT05359809
• Lead Sponsor: Ataturk University

Brief Summary

This study will be conducted to evaluate the effect of grasping reflex stimulation applied during peripheral intravenous central catheter (PIC) intervention on pain and stress in preterm infants receiving treatment and care in the neonatal intensive care unit.

Detailed Description

The study was planned in a parallel randomized controlled trial design. The population of the research will be preterm infants followed in the Newborn Intensive Care Unit of Atatürk University Health Research and Application Center between May 2022 and September 2022. Randomization in the sample of the study will be done in the computer environment. Sample size was determined by power analysis. In the collection of data; Preterm Baby Information Form, Preterm Baby Follow-up Form, Neonatal Stress Scale and ALPS-NEO pain and stress assessment scale will be used. In the control group, the PIC intervention will be performed by the investigator in accordance with clinical procedures. In the experimental group, the baby's grasping reflex stimulation will be provided during the PIC attempt.

Study Timeline

• Study First Submitted: 2022-04-29
• Study First Submitted QC: 2022-04-29
• Study Start: 2022-05-01
• Study First Posted: 2022-05-04
• Primary Completion: 2022-09-30
• Study Completion: 2022-10-30
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Between 26-32 weeks of gestation,
• Birth weight of 1500 g and below,
• No congenital defects
• who need PIC intervention while receiving treatment and care in the NICU,
• Not receiving sedation at least 3 hours before the PIC procedure,
• No neurological problems
• No surgical intervention
• Recipient of noninvasive mechanical ventilation
• infants whose parents approved the informed voluntary consent form

Exclusion Criteria

• Painful procedure (invasive procedure, etc.) has been performed in the last hour,
• Infants without parental informed consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grasping Palmar Reflex	Graspin Palmar Reflex Stimulation	-

Primary Outcome Measures

Name	Time	Method
Pain Level	12 week	Neonatal pain and stress rating scale: The scale was developed by Lundqvist et al. in 2014. It is used to measure pain and stress in preterm and term newborns. The scale is a five-item scale that includes the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activity, and activity level. The lowest score that can be obtained from the scale is 0 and the highest score is 10. As the scale score increases, it indicates that the level of pain and stress increases.
Stress Levell	12 week	Neonatal stress scale: It was developed to evaluate stress in premature babies. The scale consists of eight items; facial expression, body color, respiration, activity level, comfortability, muscle tone, extremities, and posture. Scale It is a 3-point Likert type and is evaluated between 0-2 points in scoring. A minimum of 0 points from the scale, A maximum of 16 points is taken. As the score increases, the baby's stress level increases.

Trial Locations

Locations (1)

Ataturk University; 🇹🇷 Erzurum, Turkey