Anxiety Clinical Trial
— ReViCTOOfficial title:
Decreasing Patient Anxiety During Percutaneous Revascularization of Chronic Total Coronary Occlusions Using Virtual Reality Glasses.
Percutaneous coronary angioplasty on chronic total occlusions is a complex procedure. The possibility of performing these procedures without anesthesia and sedation avoids the risks associated with anesthesia and sedation, but, on the contrary, subjects the patient to pain and anxiety during the procedure. Virtual reality (VR) has been successfully used in several clinical settings to reduce intra-procedural anxiety. The aim of this clinical trial is to determine whether the use of a VR system in PCI procedures on CTO decreases the level of anxiety and pain during the procedure.
Status | Recruiting |
Enrollment | 58 |
Est. completion date | December 1, 2023 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Chronic total oclussion scheduled percutaneous coronary intervention. Exclusion Criteria: - Less than 18 years old. - Visual deficits - Dementia - Language barrier - Any other situation that would prevent the use of VR goggles. - Inability or refusal to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico Universitario de Valencia | Valencia | Comunitat Valenciana |
Lead Sponsor | Collaborator |
---|---|
Fundación para la Investigación del Hospital Clínico de Valencia |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anxiety | Maximum level of anxiety perceived by the patient measured by a visual analog scale (VASa) (1-10) and determined at the end of the procedure. | Intraprocedure | |
Secondary | Pain level | Maximum pain level perceived by the patient measured by a visual analog scale (VASa) (1-10) and determined at the end of the procedure. | Intraprocedure | |
Secondary | Need of anxiolytic treatment | Need of anxiolytic farmacological treatment (opioids or benzodiazepines) during the procedure. | Intraprocedure |
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