Veın Imagıng Devıce And Vırtual Realıty (ven-VR)

The Effect Of Vein Imaging Device And Virtual Reality On Catheter Intervention Success, Procedure Related Outcomes During Peripheral Intravenous Catheterization in Children

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute; Anxiety State; Fear; Emotional Distress
• Intervention / Treatment: Device: vein viewer; Device: virtual reality; Device: vein viewer and virtual reality

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İzmir, Turkey, 35100
    • Gülçin Özalp Gerçeker

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vein viewer; The vein imaging device was used before the vascular access attempt	Device: 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.
Experimental: virtual reality; wearing virtual reality glasses	Device: virtual reality; The child watched the application by wearing virtual glasses during the PIC insertion
Experimental: vein viewer and virtual reality; The vein imaging device was used before the vascular access attempt and wearing virtual reality glasses	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
No Intervention: Control group; standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)]

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Gulcin Ozalp Gerçeker, Assoc. Prof., Dokuz Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Actual): December 22, 2022
• Study Completion (Actual): December 22, 2022

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: February 2, 2024
• First Posted (Estimated): February 6, 2024

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain
• Other Study ID Numbers: ven-VR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes