Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.

Study Overview
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Brief Summary
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Pain management is a priority axis of health insurance spending objectives and contributes to improving the quality of care.There are several types of pain: acute, chronic and induced. These are often found in the management of chronic wounds. The high prevalence of chronic wounds represents a major public health problem. Chronic wounds require long, painful and regular treatment. When dressing these wounds, pain management is essential. Indeed, it can generate healing delays. Usually, pharmacological methods are used to reduce the pain induced by care. But these methods can lead to undesirable effects. Thus, new non-pharmacological techniques are emerging.The investigators therefore wish to assess the effect of virtual reality on pain induced by care during the repair of dressings in the management of chronic wounds.

Official Title
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Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds: Multicentric Randomized Controlled Trial.

Conditions
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Chronic Wounds

Intervention / Treatment
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* Device: virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Knowing how to read and write French Able to understand the issues of the study and give consent Carrier of a chronic wound (ulcers, bedsores or wounds of the diabetic foot) Requiring a weekly dressing treatment in the department for at least 4 successive treatments(4 weeks) With pain during pre-inclusion care at least ≥3 to the Visual Analog Scale Person with cognitive and sensory capacities adapted to Virtual Reality (pre-inclusion verification on a device test of 5 to 10 minutes) Person affiliated or beneficiary of a social security scheme Exclusion Criteria: Carriers of a wound located on the face or end of the head and interfering with the proper use of the Virtual Reality mask Visually impaired and / or hard of hearing impacting the correct use of the Virtual Reality mask (test of 5 to 10 minutes of the device during the pre-inclusion visit) Patient not fluent in French. Current diagnosis of epilepsy, dementia or other neurological diseases preventing the use of Virtual Reality hardware and software Patients under guardianship or curators

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Classic protocol for pain management<br>classic protocol for pain management during chronic wound dressing | |
| Experimental: Virtual reality for pain management<br>protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings | Device: virtual reality<br>* Use of a virtual reality headset while caring for chronic wound dressings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment-induced pain | (AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of situational anxiety | (STAI-Y-A) State-Trait Anxiety Scale - Overall score varies between 20 and 80. The higher the score, the more anxious the patient. | 4 weeks | 
| Duration of treatment | time in seconds | 4 weeks | 
| Worse Treatment-induced pain | Analog Visual Scale | 4 weeks | 
| Frequency of use of analgesic | analgesic consumption | 4 weeks | 
| Time spent thinking about pain | (AVS) Analog Visual Scale 0 to 10 : 0 for no thought of pain ; 10 for throughout the treatment | 4 weeks | 
| Healing process | measurement of the wound on photograhies by imageJ ® planimetry software | 4 weeks | 
| Medical Outcome Study Short Form | (SF6) Short Form (36) Health Survey_ Quality of life questionnaire | 4 weeks | 
| Tolerance of virtual reality | frequency of occurrence and intensity of motion sickness events | 4 weeks |