Veın Imagıng Devıce And Vırtual Realıty

NCT ID: NCT06243419

Last Updated: 2024-02-06

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-22

Brief Summary

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The aim of this study was to evaluate the effect of a vein imaging device and virtual reality distraction on the success of peripheral intravenous catheter (PIC) placement, intervention duration, emotional appearance, pain, fear, and anxiety related to PIC intervention in children aged 4-10 years in a pediatric emergency unit.

Detailed Description

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The children were divided into four groups: control group, vein imaging group, virtual reality group, and vein imaging and virtual reality group. The duration of the intervention and the number of PIC interventions performed on each patient were recorded. The children were assessed before and after the procedure using the Emotional Appearance Scale for Children. After the procedure, the Child Fear Scale and Child Anxiety Scale-State were used to evaluate the most painful moment experienced by the child during the procedure using the Wong-Baker FACES (WB-FACES) and Color Analog Scale.

Conditions

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Pain, Acute Emotional Distress Fear Anxiety State

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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vein viewer

The vein imaging device was used before the vascular access attempt

Group Type EXPERIMENTAL

vein viewer

Intervention Type DEVICE

The PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined.

virtual reality

wearing virtual reality glasses

Group Type EXPERIMENTAL

virtual reality

Intervention Type DEVICE

The child watched the application by wearing virtual glasses during the PIC insertion

vein viewer and virtual reality

The vein imaging device was used before the vascular access attempt and wearing virtual reality glasses

Group Type EXPERIMENTAL

vein viewer and virtual reality

Intervention Type DEVICE

The PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined.

The child watched the application by wearing virtual glasses during the PIC insertion

Control group

standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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vein viewer

The PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined.

Intervention Type DEVICE

virtual reality

The child watched the application by wearing virtual glasses during the PIC insertion

Intervention Type DEVICE

vein viewer and virtual reality

The PIC region was visualized with the help of the device, and the vein to which the intervention would be applied was determined.

The child watched the application by wearing virtual glasses during the PIC insertion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Children between the ages of 4-10
* The child agrees to voluntarily participate in the study.
* Parents agree to voluntarily participate in the study
* Obtaining consent from the child and parent

Exclusion Criteria

* Need for urgent resuscitation
* Having a fever (\>37.5C) and severe dehydration
* The fact that the patient had taken analgesics before the PIC intervention.
Minimum Eligible Age

4 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Gülçin Özalp Gerçeker

pHD, Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gülçin Özalp Gerçeker, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University

Locations

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Gülçin Özalp Gerçeker

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Can M, Ozalp Gerceker G. The effect of the Veinlite PEDI2 and passive virtual reality distraction on peripheral catheter insertion-related emotional behavior, pain, fear, and anxiety of children: A randomized controlled trial. J Pediatr Nurs. 2024 Sep-Oct;78:e227-e235. doi: 10.1016/j.pedn.2024.07.010. Epub 2024 Jul 26.

Reference Type DERIVED
PMID: 39060169 (View on PubMed)

Other Identifiers

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ven-VR

Identifier Type: -

Identifier Source: org_study_id

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