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Completed

NCT Number: NCT04561596

Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

The aim of our study is to compare patients anxiety and pain during percutaneous vascular interventions with and without virtual reality autohypnosis.

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Key information

Conditions

Anxiety Postoperative Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Vascular Access Site Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

About this study

The participants in the control group will be treated under local anesthesia, following the usual care protocols.

The participants in the experimental group will be treated under the same conditions, except that they will experience virtual reality autohypnosis during the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent as documented by signature
  • > 18 years
  • Any indication for a percutaneous vascular interventional with a single vascular access (angiography, phlebography, arterial intervention, venous intervention) planned to be done under local anesthesia

Exclusion criteria

  • No French language comprehension, deaf or visually impaired patient
  • Inability to sign informed consent
  • Need of sedative medication
  • History of motion sickness
  • History of psychiatric disease such as paranoia, schizophrenia, deep water phobia and dementia
  • Patient does not tolerate the virtual reality mask during the pre operative visit at Day 1

Treatment and study plan

OnComfort autohypnosis

Device

Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.

The participant will then fill the pre and post-operative anxiety and pain questionnaire.

The percutaneous vascular procedure will be performed as usual except for the virtual reality mask and autohypnosis software that will run during the whole intervention.

Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.

A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention.

Treatment as usual, without the OnComfort autohypnosis system

Other

The Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.

The participant will then fill the pre and post-operative anxiety and pain questionnaire.

The percutaneous vascular procedure will be performed as usual. Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.

A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention.

Primary outcomes

  1. Per procedural anxiety.

    Time frame: Day 1 (Immediately after the peripheral vascular intervention)

    Per procedural anxiety, measured by the Spielberger Anxiety State Inventory in French (Gauthier and Bouchard, 1993).

    The Spielberger Anxiety State Inventory is a self questionnaire of 20 items, each item scores from 1 to 4. The result of the test is the sum of the 20 items, therefore the result ranges from 20 to 80. A high score is related to a high level of anxiety at the moment of the test.

Secondary outcomes

  1. Per procedural pain.

    Time frame: Day 1 (Immediately after the peripheral vascular intervention)

    Per procedural pain, measured by the visual analog pain scale. The visual analog pain scale rates pain from 0 to 10, 0 being the least pain imaginable and 10 the maximal pain imaginable.

  2. Remembered per procedural anxiety.

    Time frame: 3 months

    Remembered per procedural anxiety measured by the Spielberg Anxiety State Inventory in French (Gauthier and Bouchard, 1993).

    The Spielberger Anxiety State Inventory is a self questionnaire of 20 items, each item scores from 1 to 4. The result of the test is the sum of the 20 items, therefore the result ranges from 20 to 80. A high score is related to a high level of anxiety at the moment of the test.

  3. Remembered per procedural pain.

    Time frame: 3 months

    Remembered per procedural pain will be measured by the visual analog pain scale.

    The visual analog pain scale rates pain from 0 to 10, 0 being the least pain imaginable and 10 the maximal pain imaginable.

  4. Adverse events

    Time frame: Day 1

    Device deficiencies

  5. Serious adverse events

    Time frame: Day 90

    Amputation, mesenteric or renal ischemia, and death

Sponsors and collaborators

Lead sponsor

Salah D. Qanadli, MD, PhD

Other

Registry information

Official study title

Virtually Augmented Self Hypnosis: Randomized Controlled Trial in Peripheral Vascular Interventions

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Sep 23, 2020
Registry last updated
Sep 30, 2022

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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