Virtual Reality for Preoperative Anxiety in Interventional Cardiology

NCT04242563 | Completed

• 1 other identifier: 38RC19.116
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarography

  Heart rate variability during 20 minutes by a heart rate monitor in transfer room

  Time 1 : 60 minutes

Secondary Outcomes (7)

• Evaluation of anxiety level in patient awaiting coronarography

  TIme 1 : 60 minutes, Time 2 : 120 minutes

• Patient satisfaction on the global care in the coronary angiography room

  Time 3 : 180 minutes

• Impact of virtual reality on coronarography intervention duration

  Time 2 : 120 minutes

• Impact of virtual reality on coronarography irradiation dose

  Time 2 : 120 minutes

• Impact of virtual reality on coronarography scopy time

  Time 2 : 120 minutes

Study Arms (2)

CONTROL GROUP

NO INTERVENTION

No virtual reality

INTERVENTION GROUP

EXPERIMENTAL

Patient equipped with Virtual reality in transfer room.

Other: VIRTUAL REALITY

Interventions

VIRTUAL REALITY OTHER

Patient equipped with virtual reality in transfer room

INTERVENTION GROUP

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

Grenoble University Hospital

Grenoble, 38043, France

Location

Related Publications (1)

• 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.

  PMID: 37611412 RESULT

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 27, 2020
• Study Start: February 2, 2020
• Primary Completion: July 12, 2021
• Study Completion: July 12, 2021
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)