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OpenTrials
Completed

NCT Number: NCT04242563

Virtual Reality for Preoperative Anxiety in Interventional Cardiology

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble University Hospital

Grenoble, 38043, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality

Other

Patient equipped with virtual reality in transfer room

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

    Time frame: Time 1 : 60 minutes

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

Secondary outcomes

  1. Evaluation of anxiety level in patient awaiting coronarography

    Time frame: TIme 1 : 60 minutes, Time 2 : 120 minutes

    The Analogical Self-Assessment Scale for Preoperative Anxiety (0 - no anxiety to 10 - uncontrollable anxiety)

  2. Patient satisfaction on the global care in the coronary angiography room

    Time frame: Time 3 : 180 minutes

    Patient satisfaction questionnaire

  3. Impact of virtual reality on coronarography intervention duration

    Time frame: Time 2 : 120 minutes

    Intervention duration (in minutes)

  4. Impact of virtual reality on coronarography irradiation dose

    Time frame: Time 2 : 120 minutes

    Irradiation dose (in Gy.cm²)

  5. Impact of virtual reality on coronarography scopy time

    Time frame: Time 2 : 120 minutes

    scopy time (in minutes)

  6. Impact of virtual reality on administration of analgesic and anxiolytic drug peri and per coronarography procedure

    Time frame: Time 2 : 120 minutes

    administration of analgesic and anxiolytic drug peri and perprocedure (drug name and dose)

  7. Impact of virtual reality on rate and success of coronarography procedure

    Time frame: Time 2 : 120 minutes

    number and success of PCI

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: No PANIC

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2020
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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