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

C

Centre Hospitalier Universitaire de la Réunion

Status

Unknown

Conditions

Chronic Wounds

Treatments

Device: virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT04411264
2019/CHU/12

Details and patient eligibility

About

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.

Enrollment

124 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

124 participants in 2 patient groups

Classic protocol for pain management
No Intervention group
Description:
classic protocol for pain management during chronic wound dressing
Virtual reality for pain management
Experimental group
Description:
protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings
Treatment:
Device: virtual reality

Trial contacts and locations

2

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Central trial contact

Lucie AUZANNEAU

Data sourced from clinicaltrials.gov

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