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Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

NCT04561596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-09-30

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Salah D. Qanadli, MD, PhD

    lead OTHER

Principal Investigators

  • Salah Dine Qanadli, Prof. MD PhD · Unil, CHUV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-23
Primary Completion
2020-10-05
Completion
2022-08-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04561596 on ClinicalTrials.gov