Virtual Reality Distraction During Phlebotomy in Children

Pain, Acute Clinical Trial

— activeVR  

Official title:

The Effects of Virtual Reality on Procedure-Related Emotional Appearance, Pain, Fear, and Anxiety During Phlebotomy in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06336811
• Other study ID #: DEU active-pasive VR
• Status: Completed
• Phase: N/A
• Start date: May 30, 2023
• Est. completion date: December 30, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anxiety and Fear
• Child, Only
• Pain, Acute

Intervention

Device:
• passive virtual reality distraction
watching the application by wearing virtual glasses to the child during the phlebotomy
• active virtual reality distraction
The remote control of the virtual glasses will be given to the hand, and the child will start, slow down or stop the application herself.

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	procedure related pain	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).	3 minutes after the phlebotomy
Primary	anxiety	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	3 minutes before and after the phlebotomy
Primary	fear	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.	3 minutes before and after the phlebotomy
Primary	emotional apperance	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	3 minutes before and after the phlebotomy