NCT04561596

Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Salah D. Qanadli, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Anxiety Postoperative
• Pain, Postoperative
• Vascular Access Site Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-09-23
• Primary completion: 2020-10-05
• Completion: 2022-08-31
• First posted: 2020-09-23
• Last updated: 2022-09-30

Locations

1 site across 1 country: Switzerland