Peripheral Intravenous Central Catheter Intervention in Preterm Infants

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359809
• Other study ID #: B.30.2.ATA.O.01.00/264
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: October 30, 2022

Study information

• Verified date: January 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Nursing Caries
• Pain, Acute
• Premature Birth
• Preterm
• Stress

Intervention

Behavioral:
• Graspin Palmar Reflex Stimulation
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.

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (2)

Lead Sponsor	Collaborator
Ataturk University	MSc Iknur Budancamanak

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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