Decreasing Patient Anxiety During Revascularization of Chronic Total Coronary Occlusions Using Virtual Reality Glasses.

NCT05458999 | Unknown

• 1 other identifier: 2022/031
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Total Occlusion; Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain level

  Intraprocedure

• Need of anxiolytic treatment

  Intraprocedure

Study Arms (2)

Virtual reality headset

EXPERIMENTAL

Virtual reality headset during percutaneous coronary intervention

Other: Virtual reality headset during percutaneous coronary intervention

Control

NO INTERVENTION

Routine clinical practice

Interventions

Virtual reality headset during percutaneous coronary intervention OTHER

Virtual reality glasses during percutaneous coronary intervention

Virtual reality headset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic total oclussion scheduled percutaneous coronary intervention.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Agustín Fernández-Cisnal, MD

CONTACT

+34635557952; fecia82@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interventional Cardiologist

Model Details: Randomized, single-center, prospective, open-label study.

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 14, 2022
• Study Start: December 1, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)