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Completed
NCT07866417
Implementation of Virtual Reality in Nuclear Medicine
Conditions: Virtual Reality
Sex: All
Ages: 2 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 250
Sponsor: Fundacion Miguel Servet
Location: Hospital Universitario de Navarra Pamplona Navarre
Summary
Introduction: In the field of medicine, diagnostic tests are essential for the early detection and effective treatment of various diseases. However, these tests often cause patients significant pain and anxiety, which can affect their experience and their willingness to undergo future medical procedures. The use of Virtual Reality can mitigate these effects, improving the experience and thereby the cooperation of patients undergoing painful and complex procedures.
Objective: To evaluate the effect of using Virtual Reality on pain and anxiety in patients undergoing a complex diagnostic procedure.
Method: A randomized, parallel-group, 1:1 (control/intervention) superiority trial comparing the use of the conventional technique (Group 1) with the ReViMed technique (Group 2) via random assignment, with a sample size of 72 pediatric patients and 110 adult patients for each arm. The M-YPAS scale will be used to measure anxiety levels in children, and the DASS-21 for anxiety in adult patients; the pain assessment scale for all participants will be the EVA-VAS.
Impact: The implementation of VR use represents an effective distraction process for reducing anxiety and pain experienced by patients undergoing highly complex diagnostic tests.
Eligibility Criteria
As selection criteria, any case in which the patient's user or guardians, after being informed of the study's participation, do not agree to the patient's inclusion or refuse to give consent will be considered an exclusion criterion. Likewise, all patients with significant visual field impairment and severe facial injury or impairment, as well as those undergoing diagnostic tests involving the head and neck-such as parathyroid scintigraphy, salivary gland scintigraphy, DATScan, brain SPECT, and thyroid scintigraphy-will be excluded from the study.
Inclusion criteria:
* Diagnostic bone, renal, or perfusion-ventilation scintigraphy
* Glasgow Coma Scale \>13
* Adequate communication skills and understanding of the primary language (Spanish or English)
* Age over 2 years
Exclusion criteria:
* Intolerance to devices in the facial area
* Facial malformation
* Acute or significant visual impairment
* Dizziness or discomfort prior to the test
Source: ClinicalTrials.gov (NCT07866417). StuddyBuddy aggregates publicly available trial information.