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

Chronic Wounds Clinical Trial

— DouReV  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04411264
• Other study ID #: 2019/CHU/12
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Lucie AUZANNEAU
• Phone: 0262359949
• Email: lucie.auzanneau[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 124
• Est. completion date: May 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Wounds
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Limoges	Limoges
France	Centre Hospitalier Universitaire de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment-induced pain	(AVS) Analog Visual Scale 0 to 10 : 0 for no pain ; 10 for maximum pain imaginable	4 weeks
Secondary	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
Secondary	Duration of treatment	time in seconds	4 weeks
Secondary	Worse Treatment-induced pain	Analog Visual Scale	4 weeks
Secondary	Frequency of use of analgesic	analgesic consumption	4 weeks
Secondary	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
Secondary	Healing process	measurement of the wound on photograhies by imageJ ® planimetry software	4 weeks
Secondary	Medical Outcome Study Short Form	(SF6) Short Form (36) Health Survey_ Quality of life questionnaire	4 weeks
Secondary	Tolerance of virtual reality	frequency of occurrence and intensity of motion sickness events	4 weeks