Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

NCT04561596 | Completed DMC

• 1 other identifier: 2020-00728
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Postoperative; Pain, Postoperative; Vascular Access Site Pain

Keywords

Anxiety; Pain; Virtual reality; Virtual reality autohypnosis; Hypnosis; Non-pharmacological approaches

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Per procedural pain.

  Day 1 (Immediately after the peripheral vascular intervention)

• Remembered per procedural anxiety.

  3 months

• Remembered per procedural pain.

  3 months

• Adverse events

  Day 1

• Serious adverse events

  Day 90

Study Arms (2)

Autohypnosis

EXPERIMENTAL

Use of virtual reality with head mounted display

Device: OnComfort autohypnosis

Control

OTHER

Treatment as usual

Other: Treatment as usual, without the OnComfort autohypnosis system

Interventions

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.

Autohypnosis

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.

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salah D. Qanadli, MD, PhD: lead

Study Sites (1)

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

• Gullo G, Rotzinger DC, Colin A, Frossard P, Gudmundsson L, Jouannic AM, Qanadli SD. Virtually Augmented Self-Hypnosis in Peripheral Vascular Intervention: A Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2023 Jun;46(6):786-793. doi: 10.1007/s00270-023-03394-1. Epub 2023 Mar 21.

  PMID: 36944851 DERIVED

• 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.

  PMID: 35196310 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Officials

• Salah Dine Qanadli, Prof. MD PhD

  Unil, CHUV

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 23, 2020
• Study Start: September 23, 2020
• Primary Completion: October 5, 2020
• Study Completion: August 31, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)