Virtual Reality Distraction During Phlebotomy in Children

Not Applicable

Completed

• Conditions: Child, Only; Pain, Acute; Anxiety and Fear
• Interventions: Device: active virtual reality distraction; Device: passive virtual reality distraction

• Registration Number: NCT06336811
• Lead Sponsor: Dokuz Eylul University

Brief Summary

This randomized controlled study was conducted to evaluate the effect of distraction methods using virtual reality on the emotional appearance, pain, fear, and anxiety associated with the procedure during phlebotomy in children aged 6-12 in a private blood collection unit.

Detailed Description

The data of the study was collected with Socio-demographic Data Collection Form, Emotional Appearance Scale for Children, Facial Expression Rating Scale, Child Anxiety Scale-State, and Child Fear Scale. Demographic data and mean scores obtained from the scales were compared between the virtual reality groups, and the control group.

Study Timeline

• Study Start: 2023-05-30
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-22
• Study First Submitted QC: 2024-03-22
• Last Update Submitted: 2024-03-22
• Study First Posted: 2024-03-29
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• The child agrees to participate in the study voluntarily.
• The parent agrees to participate in the study voluntarily.
• Obtaining consent forms from the child and parent

Exclusion Criteria

• The child has a physical and psychological deficit that will prevent him from wearing the glasses that will be placed on his head to watch virtual reality.
• Having fever (>37.5C) and severe dehydration
• The patient did not take analgesics before the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
active Virtual reality	active virtual reality distraction	The remote control of the virtual glasses will be given to the hand that will not be interfered with, and the child will start, slow down or stop the application herself. Samsung Gear Oculus Guest 2 headset allows watching virtual reality applications.
passive virtual reality	passive virtual reality distraction	It was said that he could watch videos by wearing virtual headset glasses during the procedure. A virtual reality application that will attract the attention of children was determined by the researchers.

Primary Outcome Measures

Name	Time	Method
procedure related pain	3 minutes after the phlebotomy	Wong-Baker FACES (WBS) Pain Rating Scale. This scale uses in children aged 3 and older to rate pain severity, ranges from 0 (very happy/no pain) to 10 (hurts worst).
anxiety	3 minutes before and after the phlebotomy	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
fear	3 minutes before and after the phlebotomy	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.
emotional apperance	3 minutes before and after the phlebotomy	This scale allows direct behavioral observation, 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 represents 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. Higher scale score indicates the appearance of more negative emotional behaviors

Trial Locations

Locations (1)

Gülçin Özalp Gerçeker; 🇹🇷 İzmir, Turkey