Skip to main content
Clinical Trials/NCT05359809
NCT05359809
Completed
N/A

The Effect of Grasping Palmar Reflex on Pain and Stress in Peripheral Intravenous Central Catheter Intervention in Preterm Infants

Ataturk University1 site in 1 country40 target enrollmentMay 1, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Preterm
Sponsor
Ataturk University
Enrollment
40
Locations
1
Primary Endpoint
Pain Level
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2022
End Date
October 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Türkan Kadiroğlu

Principal Investigator

Ataturk University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain Level

Time Frame: 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

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials