Peripheral Arterial Disease
Conditions
Keywords
Virtual reality, pain management, virtual reality headset
Brief summary
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.
Detailed description
The prevalence of peripheral arterial disease (PAD) increases with age. In high-income countries, it is 5% between the ages of 45 and 49, and 18% after the age of 85. In France, nearly 1 million people are affected by this disease. 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. Local anesthesia causes discomfort related to the operating environment (low temperature, harsh lighting, noise, supine position, arms along the body, cold, hard, narrow table), impacting patient cooperation and making the procedure difficult, with the need to take multiple X-rays and reinject potentially nephrotoxic contrast agents. It can lead to the procedure being stopped, with serious consequences (postponement, persistent or even worsening pain, amputation, death). Non-pharmacological methods such as virtual reality (VR) are increasingly being used as an alternative to general anesthesia and excessive opioid use. It has proven effective in managing pain and anxiety during various medical, surgical, and endovascular procedures. Its high-quality graphics immerse the patient; hypnotic speech and relaxing elements capture the patient's attention; breathing exercises help manage stress; and relaxing music creates a soothing atmosphere. This support ensures greater mental and physical comfort by reducing pain and anxiety. The hypothesis is that VR could reduce pain during lower limb revascularization by endovascular surgery.
Interventions
DEVICEThe patient will be equipped with VR headsets
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.
Sponsors
Poitiers University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. * Free subject, without guardianship, curatorship, or subordination. * Patient who has given their free and informed consent.
Exclusion criteria
* 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); * Persons requiring enhanced protection, namely persons deprived of their liberty by judicial or administrative decision, pregnant women, and finally patients in life-threatening situations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The maximum level of pain experienced by the patient during the procedure | At the end of the revascularization 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) in mmHg | 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. | — |
| Diastolic Blood Pressure (DBP) in mmHg | 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. | — |
| Heart Rate (HR) in cycles/min | 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. | — |
| Respiratory Rate (RR) in Breaths Per Minute (BPM) | 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. | — |
| Cumulated doses of analgesics consumed during the procedure (in mL/kg) | During the revascularization procedure | Cumulated doses will be standardized in mL/kg in order to obtain comparable measures accros patients |
| The dose of X-ray radiation | During the procedure of revascularization of the lower limbs by endovascular surgery | Total dose of X-ray radiation absorbed by the patient (dose-area product, in mGy.cm²) |
| The total volume of contrast medium delivered during the procedure | During the procedure of revascularization of the lower limbs by endovascular surgery | — |
| The difference between the duration of the procedure as perceived by the patient and the actual duration of the procedure (in minutes) | At the end of the procedure of revascularization of the lower limbs by endovascular surgery | — |
| The success rate of the procedure | At the end of the procedure of revascularization of the lower limbs by endovascular surgery | Proportion of procedures performed successfully (total revascularization of the artery) |
| Proportion of patients who kept the virtual reality headsets on throughout the procedure | Throughout the procedure of lower limb revascularization through endovascular surgery | Outcome assessed for the experimental group only (with VR headset) |
| Satisfaction level of the virtual reality headset | At the end of the procedure of lower limb revascularization through endovascular surgery | Satisfaction will be measured with a numerical rating scale ranging from 0 (not satisfied at all) to 10 (completely satisfied). Outcome assessed for the experimental group only (with VR headset) |
| Comfort level experienced by the patient during the procedure | Comfort will be assessed at the end of the revascularization procedure | Comfort will be measured after the procedure using a numerical rating scale ranging from 0 (very uncomfortable) to 10 (very comfortable). |
| Cumulated doses of morphine derivatives consumed during the procedure (in mL/kg) | During the revascularization procedure | Cumulated doses will be standardized in mL/kg in order to obtain comparable measures accross patients |
| The difference in anxiety measures assessed at baseline and just after the intervention | At Baseline and just after the intervention of lower limb revascularization through endovascular surgery | 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). |
| Cumulated doses of anesthetics consumed during the procedure (in mL/kg) | During the revascularization procedure | Cumulated doses will be standardized in mL/kg in order to obtain comparable measures accross patients |
Countries
France
Contacts
CONTACTAmélie PETIT
Outcome results
None listed