Peripheral Intravenous Central Catheter Intervention in Preterm Infants

NCT05359809 | Completed

• 1 other identifier: B.30.2.ATA.O.01.00/264
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm; Pain, Acute; Stress; Nursing Caries

Keywords

Preterm; Pain, Acute; Stress; Nursing Caries

Outcome Measures

Primary Outcomes (2)

• Pain Level

  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.

  12 week

• Stress Levell

  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.

  12 week

Study Arms (2)

Grasping Palmar Reflex

EXPERIMENTAL

Behavioral: Graspin Palmar Reflex Stimulation

Control

NO INTERVENTION

Interventions

Graspin Palmar Reflex Stimulation BEHAVIORAL

The grasping reflex is an involuntary response involving the hands and fingers. flexion-adduction movement. The reflex resembles the grasping movement of the hand. The reflex can be achieved by moving an object distally across the palm.

Grasping Palmar Reflex

Eligibility Criteria

• Age: 26 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ataturk University: lead
• MSc İknur Budancamanak: collaborator

Study Sites (1)

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth; Acute Pain

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: May 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 30, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)