Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.
- Conditions
- Chronic Wounds
- Interventions
- Device: virtual reality
- Registration Number
- NCT04411264
- Lead Sponsor
- Centre Hospitalier Universitaire de la Réunion
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Virtual reality for pain management virtual reality protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings
- Primary Outcome Measures
Name Time Method Treatment-induced pain 4 weeks (AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable
- Secondary Outcome Measures
Name Time Method Level of situational anxiety 4 weeks (STAI-Y-A) State-Trait Anxiety Scale - Overall score varies between 20 and 80. The higher the score, the more anxious the patient.
Duration of treatment 4 weeks time in seconds
Frequency of use of analgesic 4 weeks analgesic consumption
Time spent thinking about pain 4 weeks (AVS) Analog Visual Scale 0 to 10 : 0 for no thought of pain ; 10 for throughout the treatment
Medical Outcome Study Short Form 4 weeks (SF6) Short Form (36) Health Survey_ Quality of life questionnaire
Worse Treatment-induced pain 4 weeks Analog Visual Scale
Healing process 4 weeks measurement of the wound on photograhies by imageJ ® planimetry software
Tolerance of virtual reality 4 weeks frequency of occurrence and intensity of motion sickness events
Trial Locations
- Locations (2)
Centre Hospitalier Universitaire de Limoges
🇫🇷Limoges, France
Centre Hospitalier Universitaire de la Réunion
🇫🇷Saint-Pierre, France