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

NCT04411264 | Unknown

• 1 other identifier: 2019/CHU/12
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Treatment-induced pain

  (AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable

  4 weeks

Secondary Outcomes (8)

• Level of situational anxiety

  4 weeks

• Duration of treatment

  4 weeks

• Worse Treatment-induced pain

  4 weeks

• Frequency of use of analgesic

  4 weeks

• Time spent thinking about pain

  4 weeks

Study Arms (2)

Classic protocol for pain management

NO INTERVENTION

classic protocol for pain management during chronic wound dressing

Virtual reality for pain management

EXPERIMENTAL

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

Device: virtual reality

Interventions

virtual reality DEVICE

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

Virtual reality for pain management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Person affiliated or beneficiary of a social security scheme

You may not qualify if:

• Carriers of a wound located on the face or end of the head and interfering with the proper use of the Virtual Reality mask
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (2)

Centre Hospitalier Universitaire de Limoges

Limoges, 87042, France

Location

Centre Hospitalier Universitaire de la Réunion

Saint-Pierre, 97410, France

Location

Central Study Contacts

Lucie AUZANNEAU

CONTACT

0262359949; lucie.auzanneau@chu-reunion.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 2, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: May 1, 2022
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)