Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

Virtually Augmented Self Hypnosis: Randomized Controlled Trial 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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Anxiety Postoperative; Vascular Access Site Pain
• Intervention / Treatment: Device: OnComfort autohypnosis; Other: Treatment as usual, without the OnComfort autohypnosis system

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Vaud
    • Lausanne, Vaud, Switzerland, 1011
      • CHUV

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Treatment as usual	Other: Treatment as usual, without the OnComfort autohypnosis system; 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.
Experimental: Autohypnosis; Use of virtual reality with head mounted display	Device: OnComfort autohypnosis; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per procedural anxiety.	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.	Day 1 (Immediately after the peripheral vascular intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per procedural pain.	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.	Day 1 (Immediately after the peripheral vascular intervention)
Remembered per procedural anxiety.	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 months
Remembered per procedural pain.	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.	3 months
Adverse events	Device deficiencies	Day 1
Serious adverse events	Amputation, mesenteric or renal ischemia, and death	Day 90

Collaborators and Investigators

• Sponsor: Salah D. Qanadli, MD, PhD
• Investigators: Study Director: Salah Dine Qanadli, Prof. MD PhD, Unil, CHUV

Publications and helpful links

General Publications

• Qanadli SD, Gudmundsson L, Gullo G, Ponti A, Saltiel S, Jouannic AM, Faouzi M, Rotzinger DC. Virtually Augmented Self-Hypnosis applied to endovascular interventions (VA-HYPO): Randomized Controlled Trial Protocol. PLoS One. 2022 Feb 23;17(2):e0263002. doi: 10.1371/journal.pone.0263002. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2020
• Primary Completion (Actual): October 5, 2020
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Pain; Anxiety; Hypnosis; Virtual reality; Virtual reality autohypnosis; Non-pharmacological approaches
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2020-00728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No