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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Wounds
• Intervention / Treatment: Device: virtual reality

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • Centre Hospitalier Universitaire de Limoges
    • Principal Investigator: Camille DUPRAT, Nurse
  • Saint-Pierre, France, 97410
    • Centre hospitalier universitaire de la Réunion
    • Principal Investigator: Julien MAILLOT, Nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Classic protocol for pain management; classic protocol for pain management during chronic wound dressing
EXPERIMENTAL: Virtual reality for pain management; protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings	Device: virtual reality; Use of a virtual reality headset while caring for chronic wound dressings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-induced pain	(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of situational anxiety	(STAI-Y-A) State-Trait Anxiety Scale - Overall score varies between 20 and 80. The higher the score, the more anxious the patient.	4 weeks
Duration of treatment	time in seconds	4 weeks
Worse Treatment-induced pain	Analog Visual Scale	4 weeks
Frequency of use of analgesic	analgesic consumption	4 weeks
Time spent thinking about pain	(AVS) Analog Visual Scale 0 to 10 : 0 for no thought of pain ; 10 for throughout the treatment	4 weeks
Healing process	measurement of the wound on photograhies by imageJ ® planimetry software	4 weeks
Medical Outcome Study Short Form	(SF6) Short Form (36) Health Survey_ Quality of life questionnaire	4 weeks
Tolerance of virtual reality	frequency of occurrence and intensity of motion sickness events	4 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): May 1, 2022

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (ACTUAL): June 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2019/CHU/12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No