Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPoitiers University Hospital

About this trial

The prevalence of peripheral arterial disease (PAD) increases with age In addition to medical treatment, endovascular procedures can be performed, depending on the stage of the disease, to prevent complications and/or sequelae (relapse, functional loss of the affected limb, amputation, death), but also to relieve pain. This is a minimally invasive procedure most often performed under local anesthesia (LA), sometimes with the administration of sedatives (morphine and analgesics) to relieve pain and reduce anxiety related to the procedure.

Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use.

The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient suffering from PAD, scheduled to undergo endovascular surgery for lower limb revascularization under local anesthesia combined with sedation.

Age ≥ 18 years.

Patient who understands and speaks French.

Patient covered by social security or covered through a third party.

Disqualifiers

Patients with contraindications to VR headsets (mono- or binocular blindness, epilepsy, migraines, psychiatric disorders, pacemakers, hearing aids, defibrillators, recent injuries to the eyes, face, or scalp that prevent comfortable use of the headsets, etc.).

Patients with suspected intolerance to VR headsets (sensitivity to motion sickness in cars, history of balance or eye disorders, etc.);

Previous bad experience with VR headsets;

Patients undergoing local regional anesthesia (LRA);

Trial design

Design model

Parallel

Treatments tested in this trial

  • The patient will be equipped with VR headsets

    Device

    The patient will be equipped with VR headsets showing one of the six scenes from the HealthyMind® program in 3D, accompanied by hypnotic speech during the procedure.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: In addition to the usual care, the patient will be equipped with VR headsetsExperimental treatment 1 intervention
Group B: The patient will receive the usual treatment under local anesthesiaNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The maximum level of pain experienced by the patient during the procedure

The maximum level of pain will be assessed at the the end of the procedure using a numerical rating scale ranging from 0 (no pain) to 10 (worst pain imaginable)

Time frame
At the end of the revascularization procedure

Secondary outcomes

1

The difference in anxiety measures assessed at baseline and just after the intervention

Anxiety will be measured at baseline and just after the intervention using a numerical rating scale ranging from 0 for "no anxiety" to 10 for "maximum imagined anxiety": a quick, easy-to-use scale that correlates strongly with Spielberger's STAI scale (Benotsch et al., 2000).

Time frame
At Baseline and just after the intervention of lower limb revascularization through endovascular surgery
2

Systolic Blood Pressure (SBP) in mmHg

Time frame
At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
3

Diastolic Blood Pressure (DBP) in mmHg

Time frame
At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.
4

Heart Rate (HR) in cycles/min

Time frame
At Baseline before the procedure of lower limb revascularization through endovascular surgery, upon arrival in the operating room, then every 15 minutes until the end of the procedure.

Other outcomes

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