Virtual Reality for Preoperative Anxiety in Interventional Cardiology

NCT ID: NCT04242563

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 156 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-02
• Study Completion Date: 2021-07-12

Brief Summary

Improving the management of perioperative anxiety is important. Anxiety can have an impact on the intervention and can increase postoperative complications as well as emotional and behavioral incidents that then have an impact on adherence to care. These findings are also true in interventional cardiology. That is why, for several months, the Grenoble University hospital paramedical team, in collaboration with the medical profession, improved by using several techniques (educational sheet, therapeutic communication). Following a survey of the patients of Grenoble university hospital, a gray area persists in their care. The room where the patient attends his examination. The investigators would then use the new technology that makes virtual reality in the transfer room to evaluate its benefit in a random study on preoperative anxiety in interventional cardiology.

Conditions

Anxiety

Keywords

interventional cardiopathy; preoperative anxiety; virtual reality

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CONTROL GROUP

No virtual reality

Group Type: NO_INTERVENTION

No interventions assigned to this group

INTERVENTION GROUP

Patient equipped with Virtual reality in transfer room.

Group Type: EXPERIMENTAL

VIRTUAL REALITY

Intervention Type: OTHER

Patient equipped with virtual reality in transfer room

Interventions

VIRTUAL REALITY

Patient equipped with virtual reality in transfer room

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Major male or female patient
• Coronarography procedure programmed for exploration of coronary artery disease following a positive ischemia test, realized in ambulatory
• Patient who has given written consent to participate in the study

Exclusion Criteria

• Arrhythmia patient and / or patient with a pacemaker
• Hemodynamic instability
• Patient who has already had coronarography
• Prior revascularization by coronary bypass
• End-stage renal disease (Creatinine clearance <30 ml / min),
• Allergy to iodine contrast agent
• Blind or visually impaired patient (high degree)
• Deaf or hard of hearing patient
• Patient with claustrophobia or unable to wear a mask over the eyes
• Patient whose physical or psychological state could compromise obtaining informed consent and compliance with protocol requirements
• Patient under administrative or judicial supervision
• Foreign patient who does not understand French
• Major patient protected by law (article L1121-8 and L1121-5)
• Pregnant or lactating patient
• Patient not affiliated with social security

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Grenoble University Hospital

Grenoble, , France

Countries

France

References

Larsson CE, Cabassut V, Peretout P, Marliere S, Vautrin E, Piliero N, Salvat M, Riou L, Vanzetto G, Vilotitch A, Bosson JL, Barone-Rochette G. Assessment of the Objective Effect of Virtual Reality for Preoperative Anxiety in Interventional Cardiology. Am J Cardiol. 2023 Oct 15;205:207-213. doi: 10.1016/j.amjcard.2023.07.130. Epub 2023 Aug 21.

Reference Type: RESULT

PMID: 37611412 (View on PubMed)

Other Identifiers

38RC19.116

Identifier Type: -

Identifier Source: org_study_id