Veın Imagıng Devıce And Vırtual Realıty

Pain, Acute Clinical Trial

— ven-VR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06243419
• Other study ID #: ven-VR
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 22, 2022

Study information

• Verified date: February 2024
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 22, 2022
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pain
• Anxiety State
• Emotional Distress
• Fear
• Pain, Acute

Intervention

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

Locations

Country	Name	City	State
Turkey	Gülçin Özalp Gerçeker	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	the success of peripheral intravenous catheter (PIC) placement	first IV attempt	at PIC insertion
Primary	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)]