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Virtual Reality for Preoperative Anxiety in Interventional Cardiology

Virtual Reality for Preoperative Anxiety in Interventional Cardiology

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04242563
Acronym
No PANIC
Enrollment
156
Registered
2020-01-27
Start date
2020-02-02
Completion date
2021-07-12
Last updated
2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety

Keywords

interventional cardiopathy, preoperative anxiety, virtual reality

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.

Interventions

OTHERVIRTUAL REALITY

Patient equipped with virtual reality in transfer room

Sponsors

University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of virutal reality on the management of preoperative anxiety measured by heart rate variability in interventional cardiology room in patient awaiting coronarographyTime 1 : 60 minutesHeart rate variability during 20 minutes by a heart rate monitor in transfer room

Secondary

MeasureTime frameDescription
Evaluation of anxiety level in patient awaiting coronarographyTIme 1 : 60 minutes, Time 2 : 120 minutesThe Analogical Self-Assessment Scale for Preoperative Anxiety (0 - no anxiety to 10 - uncontrollable anxiety)
Patient satisfaction on the global care in the coronary angiography roomTime 3 : 180 minutesPatient satisfaction questionnaire
Impact of virtual reality on coronarography intervention durationTime 2 : 120 minutesIntervention duration (in minutes)
Impact of virtual reality on coronarography irradiation doseTime 2 : 120 minutesIrradiation dose (in Gy.cm²)
Impact of virtual reality on coronarography scopy timeTime 2 : 120 minutesscopy time (in minutes)
Impact of virtual reality on administration of analgesic and anxiolytic drug peri and per coronarography procedureTime 2 : 120 minutesadministration of analgesic and anxiolytic drug peri and perprocedure (drug name and dose)
Impact of virtual reality on rate and success of coronarography procedureTime 2 : 120 minutesnumber and success of PCI

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026