Veın Imagıng Devıce And Vırtual Realıty

Not Applicable

Completed

• Conditions: Emotional Distress; Pain, Acute; Anxiety State; Fear
• Interventions: Device: virtual reality; Device: vein viewer and virtual reality; Device: vein viewer

• Registration Number: NCT06243419
• Lead Sponsor: Dokuz Eylul University

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.

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 Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-12-22
• Study Completion: 2022-12-22
• Study First Submitted: 2023-05-24
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-06
• Last Update Posted: 2024-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Emotional Appearance by Emotional Appearance Scale for Children	before the PIC insertion and immediately after the PIC insertion (on average 2-3 minutes later)]	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.
Pain assesed by Wong-Baker FACES	immediately after the vascular access (on average 2-3 minutes later)	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.
Anxiety assesed by Children Anxiety Meter-State	immediately after the vascular access (on average 2-3 minutes later)	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.
Fear assesed by Child Fear Scale	immediately after the vascular access (on average 2-3 minutes later)	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.
the success of peripheral intravenous catheter (PIC) placement	at PIC insertion	first IV attempt

Trial Locations

Locations (1)

Gülçin Özalp Gerçeker; 🇹🇷 İzmir, Turkey