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Active Virtual Reality Distraction on Procedure-Related Emotional Behaviour, Pain, And Anxiety

Active Virtual Reality Distraction on Procedure-Related Emotional Behaviour, Pain, And Anxiety During Venipuncture

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07261410
Acronym
Oculus2
Enrollment
86
Registered
2025-12-03
Start date
2025-01-01
Completion date
2025-04-01
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety State, Pain, Venipuncture

Brief summary

This study aimed to evaluate the effect of virtual reality methods on procedure-related emotional behaviour, pain, and anxiety levels in school-age children undergoing venipuncture.

Detailed description

Participants were assigned to three groups through stratified randomization: the active VR, the passive VR, and the control group. Children in the VR groups wore VR goggles (Oculus Quest 2) during venipuncture.

Interventions

DEVICEactive VR 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.

DEVICEpassive VR distraction

watching the application by wearing virtual glasses with Oculus Guest 2

Sponsors

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
procedure related pain3 minutes after the phlebotomyWong-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).
procedure related anxiety3 minutes after the phlebotomyThe 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
procedure related emotional apperanceimmediately after the phlebotomyThis 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026