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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04411264
Acronym
DouReV
Enrollment
124
Registered
2020-06-02
Start date
2020-09-01
Completion date
2022-05-01
Last updated
2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Wounds

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.

Interventions

DEVICEvirtual reality

Use of a virtual reality headset while caring for chronic wound dressings

Sponsors

Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Treatment-induced pain4 weeks(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable

Secondary

MeasureTime frameDescription
Duration of treatment4 weekstime in seconds
Worse Treatment-induced pain4 weeksAnalog Visual Scale
Frequency of use of analgesic4 weeksanalgesic consumption
Level of situational anxiety4 weeks(STAI-Y-A) State-Trait Anxiety Scale - Overall score varies between 20 and 80. The higher the score, the more anxious the patient.
Healing process4 weeksmeasurement of the wound on photograhies by imageJ ® planimetry software
Medical Outcome Study Short Form4 weeks(SF6) Short Form (36) Health Survey\_ Quality of life questionnaire
Tolerance of virtual reality4 weeksfrequency of occurrence and intensity of motion sickness events
Time spent thinking about pain4 weeks(AVS) Analog Visual Scale 0 to 10 : 0 for no thought of pain ; 10 for throughout the treatment

Countries

France

Contacts

Primary ContactLucie AUZANNEAU
lucie.auzanneau@chu-reunion.fr0262359949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026