An interventional study of ReviMed group and Control Group (A): in Virtual Reality, sponsored by Fundacion Miguel Servet. Completed at 1 site in Spain. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Fundacion Miguel Servet · Not applicable, Interventional, and Other
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.
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. In this context, virtual reality (VR) has emerged as a promising tool for reducing both the pain and anxiety associated with diagnostic tests in both adult and pediatric patients.
VR is a technology that allows users to immerse themselves in computer-generated virtual environments, creating a sense of presence and active participation in a simulated world. Through devices such as virtual reality headsets and motion controllers, users can interact with these environments and experience realistic sensations.
Medical diagnostic and therapeutic tests often involve invasive procedures, physical discomfort, or stressful clinical environments. These factors can generate high levels of pain and anxiety in patients, affecting their emotional well-being and their willingness to cooperate during the procedure. Reducing these negative experiences is crucial for improving the quality of medical care and enabling greater patient cooperation with the procedure to be performed. Several studies have shown that VR can have a positive impact on pain reduction. By distracting the patient's attention and immersing them in a pleasant and relaxing virtual environment, virtual reality can reduce the perception of pain and improve the pain tolerance threshold. Furthermore, the ability to customize virtual environments allows the experience to be tailored to each patient's individual needs and preferences.
VR has also proven effective in reducing anxiety associated with these procedures. By providing a safe and controlled virtual environment, VR can help patients relax, better adapt to the setting, and lower their anxiety levels. Furthermore, gradual exposure to specific medical situations or procedures through virtual reality can help patients become familiar with and desensitized to them, thereby reducing anticipatory anxiety.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 250 is above the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →Fundacion Miguel Servet is the lead sponsor of 47 studies on the registry; 20 are open to participants now.
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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:
Exclusion criteria:
baseline nuclear medicine imaging without sedation, anxiolytics, or the administration of a relaxant
Other: Control Group (A):
Virtual reality implementation
Other: ReviMed group
Incorporation of an interactive experience using virtual reality headsets and 360-degree video projections accompanied by long-form relaxing background music
no action
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.
Time frame: From enrollment to the end of treatment, 1 DAY
level of satisfaction
The measurement will be the mean score for satisfaction by control or intervention group with a liker scale 1-10.
Time frame: From enrollment to the end of treatment, 1 DAY
level of pain
EVA-VAS scale: a 0-10 Likert scale. The measurement will be the percentage of patients with pain (yes/no) and the mean score for pain by control and intervention group. The Visual Analog Scale (VAS) is a tool used in clinical settings to measure the intensity of pain or other subjective sensations. It consists of a straight line (usually 10 cm or 100 mm) where one end represents the absence of pain and the other end represents the worst pain imaginable. Values and Meaning of the VAS The measurement is made in centimeters or millimeters, and the values are interpreted as follows: 0: No pain / Absence of pain.0.5-4: Mild pain.4.1-7 cm: Moderate pain. \>7: Severe pain / Very intense.10: The worst pain imaginable.
Time frame: From enrollment to the end of treatment, 1 DAY
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Fundacion Miguel Servet