NCT07866417

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2026

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 8, 2026

Completed
Last Updated

October 8, 2026

Status Verified

October 1, 2026

Enrollment Period

1 year

First QC Date

March 27, 2026

Last Update Submit

October 5, 2026

Conditions

Virtual Reality

Keywords

painanxiety

Outcome Measures

Primary Outcomes (1)

  • anxiety

    The Spanish version of the Modified Yale Preoperative Anxiety Scale (m-YPAS) (EAPY-m, translated into Spanish) will be used (Jerez et al., 2016), which was designed specifically for children aged 2-12 years and has good inter- and intra-observer reliability and good validity (Kain et al., 1997; MacLaren et al., 2009; Sadhasivam et al., 2010). The measurement will be the percentage of patients with anxiety and the mean score for anxiety by intervention group. The measurement will be taken before and after the procedure, immediately following its completion.

    From enrollment to the end of treatment, 1 DAY

Secondary Outcomes (2)

  • level of satisfaction

    From enrollment to the end of treatment, 1 DAY

  • level of pain

    From enrollment to the end of treatment, 1 DAY

Study Arms (2)

control group

OTHER

baseline nuclear medicine imaging without sedation, anxiolytics, or the administration of a relaxant

Other: Control Group (A):

Revimed group

EXPERIMENTAL

Virtual reality implementation

Other: ReviMed group

Interventions

ReviMed groupOTHER

Incorporation of an interactive experience using virtual reality headsets and 360-degree video projections accompanied by long-form relaxing background music

Revimed group
Control Group (A):OTHER

no action

control group

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Intolerance to devices in the facial area
  • Facial malformation
  • Acute or significant visual impairment
  • Dizziness or discomfort prior to the test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 31007, Spain

Location

Related Publications (2)

  • Jung MJ, Libaw JS, Ma K, Whitlock EL, Feiner JR, Sinskey JL. Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial. Anesth Analg. 2021 Mar 1;132(3):798-806. doi: 10.1213/ANE.0000000000005004.

    PMID: 32618627BACKGROUND

  • Schmitt YS, Hoffman HG, Blough DK, Patterson DR, Jensen MP, Soltani M, Carrougher GJ, Nakamura D, Sharar SR. A randomized, controlled trial of immersive virtual reality analgesia, during physical therapy for pediatric burns. Burns. 2011 Feb;37(1):61-8. doi: 10.1016/j.burns.2010.07.007. Epub 2010 Aug 7.

    PMID: 20692769BACKGROUND

Related Links

MeSH Terms

Conditions

PainAnxiety Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2026

First Posted

October 8, 2026

Study Start

March 1, 2025

Primary Completion

March 1, 2026

Study Completion

March 27, 2026

Last Updated

October 8, 2026

Record last verified: 2026-10

Locations

ES(1)