Virtual-Reality and Cold-Vibration Device on Procedure-Related Fear, Anxiety and Pain During Pediatric IV Line Placement
IVVRBuzzy
The Effect of Virtual Reality and Cold Vibration Device on First Attempt Success, Procedure-Related Fear, Anxiety and Pain During Pediatric Intravenous Line Placement in Children Between 4-10 Years Old in the Emergency Department
1 other identifier
interventional
50
1 country
1
Brief Summary
Studies evaluating VR are quite insufficient. In the study we determined in the emergency room between the ages of 4-10, cold vibration and virtual reality will be compared, and the success of the first attempt, pain, fear and anxiety will be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable pain
Started Dec 2020
Shorter than P25 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2020
CompletedFirst Submitted
Initial submission to the registry
April 16, 2021
CompletedFirst Posted
Study publicly available on registry
April 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 14, 2021
CompletedFebruary 10, 2022
February 1, 2022
6 months
April 16, 2021
February 9, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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. Faces show emotions from smiling (0 = very happy/ no pain) to crying (10 = hurts worst).
during the procedure
Anxiety assesed by Children Anxiety Meter-State
The Children's Anxiety Meter (CAM-S). 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). This scale ranges from 0 to 10. Higher values represent higher anxiety
during the procedure
Fear assesed by Child Fear Scale
The Child Fear Scale (CFS). The Child Fear Scale will use.This one-item scale measures procedure-related fear in children, consists of five sex-neutral faces, ranges 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 rater responds indicates the level of fear. It can be used during the procedure for children aged 5-10 years.
during the procedure
Secondary Outcomes (1)
Emotional Appearance Scale for Children
Baseline (before the procedure)
Study Arms (3)
Virtual Reality Group
EXPERIMENTALwatching the application by wearing virtual glasses to the child during the peripheral IV line insertion
Cold Vibration Group
EXPERIMENTALBuzzy, connecting and operating 5 cm above the area to be inserted peripheral IV line
Control group
NO INTERVENTIONStandart care
Interventions
wearing virtual reality glasses
Eligibility Criteria
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 form from the child and parent
You may not qualify if:
- \- The child with physical and psychological deficit to prevent him from wearing the glasses to be worn on his head so that he can watch virtual reality.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gülçin Özalp Gerçeker
Izmir, 35100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gülçin Özalp Gerçeker
RN, PhD, Assoc. Prof.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
April 16, 2021
First Posted
April 21, 2021
Study Start
December 14, 2020
Primary Completion
June 14, 2021
Study Completion
July 14, 2021
Last Updated
February 10, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share