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Completed

NCT Number: NCT05359809

Peripheral Intravenous Central Catheter Intervention in Preterm Infants

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.

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Key information

Conditions

Preterm Acute Pain Female Urogenital Diseases and Pregnancy Complications Neurologic Manifestations Nursing Caries Obstetric Labor Complications Obstetric Labor, Premature Pain Pain, Acute Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Stress Urogenital Diseases

Age range

26 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25240, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Collaborators

  • MSc İknur Budancamanak

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 4, 2022
Registry last updated
Jan 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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