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Virtually Augmented Self Hypnosis in Peripheral Vascular Interventions

S

Salah D. Qanadli, MD, PhD

Status

Completed

Conditions

Vascular Access Site Pain
Pain, Postoperative
Anxiety Postoperative

Treatments

Device: OnComfort autohypnosis
Other: Treatment as usual, without the OnComfort autohypnosis system

Study type

Interventional

Funder types

Other

Identifiers

NCT04561596
2020-00728

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Autohypnosis
Experimental group
Description:
Use of virtual reality with head mounted display
Treatment:
Device: OnComfort autohypnosis
Control
Other group
Description:
Treatment as usual
Treatment:
Other: Treatment as usual, without the OnComfort autohypnosis system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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