Clinical trial NCT04411264: Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.
Official title: Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds: Multicentric Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Wounds
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Treatment-induced pain
timeFrame: 4 weeks
Secondary outcomes:
measure: Level of situational anxiety
timeFrame: 4 weeks
measure: Duration of treatment
timeFrame: 4 weeks
measure: Worse Treatment-induced pain
timeFrame: 4 weeks
measure: Frequency of use of analgesic
timeFrame: 4 weeks
measure: Time spent thinking about pain
timeFrame: 4 weeks
measure: Healing process
timeFrame: 4 weeks
measure: Medical Outcome Study Short Form
timeFrame: 4 weeks
measure: Tolerance of virtual reality
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges
city: Saint-Pierre
country: France
facility: Centre Hospitalier Universitaire de la Réunion
Study officials:
References: