Peripheral Intravenous Central Catheter Intervention in Preterm Infants

NCT ID: NCT05359809

Last Updated: 2023-01-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-10-30

Brief Summary

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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

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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.

Conditions

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Preterm Pain, Acute Stress Nursing Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Grasping Palmar Reflex

Group Type EXPERIMENTAL

Graspin Palmar Reflex Stimulation

Intervention Type 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.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MSc İknur Budancamanak

UNKNOWN

Sponsor Role collaborator

Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Türkan Kadiroğlu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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B.30.2.ATA.O.01.00/264

Identifier Type: -

Identifier Source: org_study_id

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