Chronic WoundsDouReVNCT04411264
Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds.
A study testing virtual reality in people with Chronic Wounds, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Wounds
- What is being tested?
- virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2020to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Limoges
Limoges, 87042
Lucie AUZANNEAU
Camille DUPRAT, Nurse
Centre Hospitalier Universitaire de la Réunion
Saint-Pierre, 97410
Lucie AUZANNEAU
Julien MAILLOT, Nurse
About this study
Official title: 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.
- Conditions
- Chronic Wounds
- Being tested
- virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
Use of a virtual reality headset while caring for chronic wound dressings
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-induced pain
(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable
Measured: 4 weeks
Secondary outcomes (8)
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.
Measured: 4 weeks
Duration of treatment
time in seconds
Measured: 4 weeks
Worse Treatment-induced pain
Analog Visual Scale
Measured: 4 weeks
Frequency of use of analgesic
analgesic consumption
Measured: 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
Measured: 4 weeks
Healing process
measurement of the wound on photograhies by imageJ ® planimetry software
Measured: 4 weeks
Medical Outcome Study Short Form
(SF6) Short Form (36) Health Survey_ Quality of life questionnaire
Measured: 4 weeks
Tolerance of virtual reality
frequency of occurrence and intensity of motion sickness events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Mar 2022 (estimated)
- Study completion1 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411264
- Sponsor's protocol ID
- 2019/CHU/12
- Acronym
- DouReV
- Status last verified
- May 2020
- First submitted
- 22 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Virtual Reality on Pain in the Management of Chronic Wounds: Multicentric Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04411264
- Acronym / sponsor ID
- DouReV / 2019/CHU/12
- Conditions
- Chronic Wounds
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 May 2022 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic protocol for pain management | No intervention | –classic protocol for pain management during chronic wound dressing |
| Virtual reality for pain management | Experimental | Device: virtual realityprotocol associating virtual reality with the classic protocol for pain management during the treatment of chronic wound dressings |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual realityUse of a virtual reality headset while caring for chronic wound dressings | Device | Virtual reality for pain management |
Primary outcome
Treatment-induced pain
Time frame: 4 weeks
(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable
8 secondary outcomes
Level of situational anxiety
Time frame: 4 weeks
Duration of treatment
Time frame: 4 weeks
Worse Treatment-induced pain
Time frame: 4 weeks
Frequency of use of analgesic
Time frame: 4 weeks
Time spent thinking about pain
Time frame: 4 weeks
Healing process
Time frame: 4 weeks
Medical Outcome Study Short Form
Time frame: 4 weeks
Tolerance of virtual reality
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Chronic Wounds, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucie AUZANNEAU (0262359949 ext. +262, lucie.auzanneau@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-induced pain (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.