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The purpose of this study is to observe or not a reduction on pain and anxiety felt by the patient when performing an ultrasound-controlled ankle block in preparation for forefoot surgery, using a virtual reality device instead of drug sedation.
Currently, in preparation for forefoot surgery, the realization of the ankle block is accompanied by drug sedation.
The investigator's randomized study aims to compare the anxiety and pain experienced by patients who have benefited from drug sedation with those of patients who benefited from the virtual reality device at the time of the realization of the ankle block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual reality | Experimental | The virtual reality device will consist of the virtual reality headset and headphones for full immersion. |
|
| Drug sedation | Active Comparator | The sedation group will benefit from drug sedation used in current practice, that is to say an association of Sufentanil, Droleptan and Propofol. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | The patient will have the choice between different environments and the use of this device will remain under the control of the medical team. The patient will wear the virtual reality device at the time of the completion of the ankle block and will remove it once the nerve puncture is complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Digital visual scale to assess pain of patients during the treatment | Numeric scale numbered from 0 to 10. 0: no pain 10 : worst possible pain | 5 min after the first nerve punction |
| Digital visual scale to assess anxiety of patients during the treatment | Numeric scale numbered from 0 to 10. 0: no anxiety 10 : worst possible anxiety | 5 min after the first nerve punction |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction questionnaire | Concerns all patients Numeric scale numbered from 0 to 10. 0: unsatisfied 10 : very satisfied | 5 min after the last nerve punction |
| Patient comfort assessment questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas PILLANT, MD | Clinique Saint Jean, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Saint Jean | Montpellier | 34090 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19377147 | Background | Mosso JL, Gorini A, De La Cerda G, Obrador T, Almazan A, Mosso D, Nieto JJ, Riva G. Virtual reality on mobile phones to reduce anxiety in outpatient surgery. Stud Health Technol Inform. 2009;142:195-200. | |
| 19955069 | Background | Furman E, Jasinevicius TR, Bissada NF, Victoroff KZ, Skillicorn R, Buchner M. Virtual reality distraction for pain control during periodontal scaling and root planing procedures. J Am Dent Assoc. 2009 Dec;140(12):1508-16. doi: 10.14219/jada.archive.2009.0102. |
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| ID | Term |
|---|---|
| D006215 | Hallux Valgus |
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004329 | Droperidol |
| D015742 | Propofol |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D002090 | Butyrophenones |
| D007659 | Ketones |
| D009930 | Organic Chemicals |
| D001562 | Benzimidazoles |
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|
|
| Droleptan | Drug | Venous administration of 1.25 mg of Droleptan |
|
|
| Propofol | Drug | Venous administration of 20 mg of Propofol |
|
|
| Sufentanyl | Drug | Venous administration of 5 μg of Sufentanyl. |
|
|
Concerns all patients. This is a question to determine their comfort levels during the experiment. Numeric scale numbered from 1 to 5.
| 5 min after the last nerve punction |
| 20509069 | Background | Patterson DR, Jensen MP, Wiechman SA, Sharar SR. Virtual reality hypnosis for pain associated with recovery from physical trauma. Int J Clin Exp Hypn. 2010 Jul;58(3):288-300. doi: 10.1080/00207141003760595. |
| 19230769 | Background | Nilsson S, Finnstrom B, Kokinsky E, Enskar K. The use of Virtual Reality for needle-related procedural pain and distress in children and adolescents in a paediatric oncology unit. Eur J Oncol Nurs. 2009 Apr;13(2):102-9. doi: 10.1016/j.ejon.2009.01.003. Epub 2009 Feb 20. |
| 19111995 | Background | Konstantatos AH, Angliss M, Costello V, Cleland H, Stafrace S. Predicting the effectiveness of virtual reality relaxation on pain and anxiety when added to PCA morphine in patients having burns dressings changes. Burns. 2009 Jun;35(4):491-9. doi: 10.1016/j.burns.2008.08.017. Epub 2008 Dec 27. |
| 16360473 | Background | Wright JL, Hoffman HG, Sweet RM. Virtual reality as an adjunctive pain control during transurethral microwave thermotherapy. Urology. 2005 Dec;66(6):1320. doi: 10.1016/j.urology.2005.06.123. |
| 7488491 | Background | Burt DE. Virtual reality in anaesthesia. Br J Anaesth. 1995 Oct;75(4):472-80. doi: 10.1093/bja/75.4.472. No abstract available. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |