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Completed

NCT Number: NCT06243419

Veın Imagıng Devıce And Vırtual Realıty

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.

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Key information

Conditions

Pain, Acute Acute Pain Anxiety Disorders Anxiety State Emotional Distress Fear Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gülçin Özalp Gerçeker

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Virtual reality

Device

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

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

Primary outcomes

  1. Pain assesed by Wong-Baker FACES

    Time frame: 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.

  2. Anxiety assesed by Children Anxiety Meter-State

    Time frame: 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.

  3. Fear assesed by Child Fear Scale

    Time frame: 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.

  4. the success of peripheral intravenous catheter (PIC) placement

    Time frame: at PIC insertion

    first IV attempt

  5. Emotional Appearance by Emotional Appearance Scale for Children

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dokuz Eylul University

Other

Registry information

Official study title

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

Acronym: ven-VR

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 6, 2024
Registry last updated
Feb 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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