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

NCT ID: NCT04411264

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2022-05-01

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.

Conditions

Chronic Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Classic protocol for pain management

classic protocol for pain management during chronic wound dressing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Virtual reality for pain management

protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings

Group Type: EXPERIMENTAL

virtual reality

Intervention Type: DEVICE

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

Interventions

virtual reality

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de la Réunion

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire de Limoges

Limoges, , France

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, , France

Countries

France

Central Contacts

Lucie AUZANNEAU

Role: CONTACT

lucie.auzanneau@chu-reunion.fr

0262359949 ext. +262

Facility Contacts

Lucie AUZANNEAU

Role: primary

Lucie AUZANNEAU

Role: primary

Other Identifiers

2019/CHU/12

Identifier Type: -

Identifier Source: org_study_id