Veın Imagıng Devıce And Vırtual Realıty

NCT06243419 | Completed DMC FDA Device

• 1 other identifier: ven-VR
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute; Emotional Distress; Fear; Anxiety State

Outcome Measures

Primary Outcomes (5)

• Pain assesed by Wong-Baker FACES

  Wong-Baker FACES (WB-FACES) Pain Rating Scale used. This scale uses in children aged 3 and older to rate pain severity. This numeric rating scale ranges from 0 to 10.

  immediately after the vascular access (on average 2-3 minutes later)

• Anxiety assesed by Children Anxiety Meter-State

  The Children's Anxiety Meter. The Children's Anxiety Meter assesses children's anxiety and uses before medical procedures. This scale is drawn like a thermometer with a bulb at the bottom and also includes horizontal lines at intervals going up to the top (0-10). higher scores mean a worse outcome.

  immediately after the vascular access (on average 2-3 minutes later)

• Fear assesed by Child Fear Scale

  The Child Fear Scale. This one-item scale measures procedure-related fear in children, consisting of five sex-neutral faces ranging from 0 (no fear) to extreme fear. This rating scale ranges from 0 to 4. It ranges from a no-fear (neutral) face (0) on the far left to a face showing extreme fear on the far right. Higher scores mean a worse outcome.

  immediately after the vascular access (on average 2-3 minutes later)

• the success of peripheral intravenous catheter (PIC) placement

  first IV attempt

  at PIC insertion

• Emotional Appearance by Emotional Appearance Scale for Children

  This scale allows direct behavioral observation, and consists of 5 different behavioral categories; 'Facial Expression', 'Speaking', 'Activity', 'Interaction' and 'Cooperation Level'. Scale scoring is done by reviewing the descriptions of behavior in each category and selecting the numerical value that most represent the observed behavior. Each category is scored from 1 to 5. The total score is made so that the numerical value is between 5-25 by adding the points obtained for each category. A higher scale score indicates the appearance of more negative emotional behaviors.

  before the PIC insertion and immediately after the PIC insertion (on average 2-3 minutes later)]

Study Arms (4)

vein viewer

EXPERIMENTAL

The vein imaging device was used before the vascular access attempt

Device: vein viewer

virtual reality

EXPERIMENTAL

wearing virtual reality glasses

Device: virtual reality

vein viewer and virtual reality

EXPERIMENTAL

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

Device: vein viewer and virtual reality

Control group

NO INTERVENTION

standard care

Interventions

vein viewer DEVICE

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

vein viewer

virtual reality DEVICE

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

virtual reality

vein viewer and virtual reality 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

vein viewer and virtual reality

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39060169 DERIVED

MeSH Terms

Conditions

Acute Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Gülçin Özalp Gerçeker, Assoc. Prof.

  Dokuz Eylul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pHD, Assoc. Prof.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: February 6, 2024
• Study Start: May 1, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)