Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 23, 2020

Primary Completion Date

October 5, 2020

Study Completion Date

August 31, 2022

Conditions
Anxiety PostoperativePain, PostoperativeVascular 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."

Trial Locations (1)

1011

CHUV, Lausanne

All Listed Sponsors
lead

Salah D. Qanadli, MD, PhD

OTHER

NCT04561596 - Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions | Biotech Hunter | Biotech Hunter