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Peripheral Intravenous Central Catheter Intervention in Preterm Infants

A

Ataturk University

Status

Completed

Conditions

Preterm
Pain, Acute
Nursing Caries
Stress

Treatments

Behavioral: Graspin Palmar Reflex Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05359809
B.30.2.ATA.O.01.00/264

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

26 to 32 weeks old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Grasping Palmar Reflex
Experimental group
Treatment:
Behavioral: Graspin Palmar Reflex Stimulation
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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