Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds. (DouReV)
Primary Purpose
Chronic Wounds
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Wounds
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
Sites / Locations
- Centre Hospitalier Universitaire de Limoges
- Centre Hospitalier Universitaire de la Réunion
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Classic protocol for pain management
Virtual reality for pain management
Arm Description
classic protocol for pain management during chronic wound dressing
protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings
Outcomes
Primary Outcome Measures
Treatment-induced pain
(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable
Secondary Outcome Measures
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.
Duration of treatment
time in seconds
Worse Treatment-induced pain
Analog Visual Scale
Frequency of use of analgesic
analgesic consumption
Time spent thinking about pain
(AVS) Analog Visual Scale 0 to 10 : 0 for no thought of pain ; 10 for throughout the treatment
Healing process
measurement of the wound on photograhies by imageJ ® planimetry software
Medical Outcome Study Short Form
(SF6) Short Form (36) Health Survey_ Quality of life questionnaire
Tolerance of virtual reality
frequency of occurrence and intensity of motion sickness events
Full Information
NCT ID
NCT04411264
First Posted
May 22, 2020
Last Updated
May 28, 2020
Sponsor
Centre Hospitalier Universitaire de la Réunion
1. Study Identification
Unique Protocol Identification Number
NCT04411264
Brief Title
Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.
Acronym
DouReV
Official Title
Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds: Multicentric Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de la Réunion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Wounds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Classic protocol for pain management
Arm Type
No Intervention
Arm Description
classic protocol for pain management during chronic wound dressing
Arm Title
Virtual reality for pain management
Arm Type
Experimental
Arm Description
protocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings
Intervention Type
Device
Intervention Name(s)
virtual reality
Intervention Description
Use of a virtual reality headset while caring for chronic wound dressings
Primary Outcome Measure Information:
Title
Treatment-induced pain
Description
(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Level of situational anxiety
Description
(STAI-Y-A) State-Trait Anxiety Scale - Overall score varies between 20 and 80. The higher the score, the more anxious the patient.
Time Frame
4 weeks
Title
Duration of treatment
Description
time in seconds
Time Frame
4 weeks
Title
Worse Treatment-induced pain
Description
Analog Visual Scale
Time Frame
4 weeks
Title
Frequency of use of analgesic
Description
analgesic consumption
Time Frame
4 weeks
Title
Time spent thinking about pain
Description
(AVS) Analog Visual Scale 0 to 10 : 0 for no thought of pain ; 10 for throughout the treatment
Time Frame
4 weeks
Title
Healing process
Description
measurement of the wound on photograhies by imageJ ® planimetry software
Time Frame
4 weeks
Title
Medical Outcome Study Short Form
Description
(SF6) Short Form (36) Health Survey_ Quality of life questionnaire
Time Frame
4 weeks
Title
Tolerance of virtual reality
Description
frequency of occurrence and intensity of motion sickness events
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie AUZANNEAU
Phone
0262359949
Ext
+262
Email
lucie.auzanneau@chu-reunion.fr
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
First Name & Middle Initial & Last Name & Degree
Camille DUPRAT, Nurse
Facility Name
Centre Hospitalier Universitaire de la Réunion
City
Saint-Pierre
ZIP/Postal Code
97410
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucie AUZANNEAU
First Name & Middle Initial & Last Name & Degree
Julien MAILLOT, Nurse
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.
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