C.H.U. Poitiers
Poitiers, 86000, France
NCT Number: NCT07181434
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Poitiers, 86000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At the end of the revascularization procedure of the lower limbs by endovascular surgery
Time frame: 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 an EN 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 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.
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.
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.
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.
Time frame: During the procedure of lower limb revascularization through endovascular surgery
Time frame: 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)
Time frame: During the procedure of revascularization of the lower limbs by endovascular surgery
Time frame: At the end of the procedure of revascularization of the lower limbs by endovascular surgery
Time frame: 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)
Time frame: Throughout the procedure of lower limb revascularization through endovascular surgery
Time frame: At the end of the procedure of lower limb revascularization through endovascular surgery
Contact information is provided by the study sponsor or research team.
Poitiers University Hospital
Other
Impact of Virtual Reality on Patient Pain During Lower Limb Revascularization Via Endovascular Surgery Under Local Anesthesia With Sedation - Randomized Study
Acronym: REVDOU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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