Immersive Virtual Reality in Orthopedics (IVR-Ortho)

Centre Hospitalier de Montauban

Status: Enrolling

Conditions: Orthopedic; Virtual Reality

Treatments: Device: Hypnotic virtual reality support using hypnosis software Hypno-VR®; Device: No Hypnotic virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05437796

2020-A00005-34

Details and patient eligibility

About

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

Full description

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

Despite a high level of approval of patients (according our satisfaction surveys) concerning hypnotic virtual reality, we want to evaluate our practice. Thus, in the future, we can invest in this type of material and make it available to a larger number of patients, but only if complementary care proves its effectiveness.

The purpose of this study is to evaluate the effectiveness of hypnotic virtual reality support on the patient's state of anxiety before and after prosthetic knee surgeries under spinal anesthesia.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eligible patients for prosthetic knee surgery under spinal anesthesia
• Patient who has received appropriate information and has provided informed consent
• Patient with French social security system

Exclusion criteria

• Patient under general anaesthesia
• Patients treated in conventional inpatient care or in the traditional ambulatory circuit
• Patient under guardianship or trusteeship
• Minor patient < 18 years of age
• Patient who has not provided informed consent or who cannot submit to the study protocol
• Patient suffering from cognitive disorders (ex: Alzheimer's disease)
• Patients who are deaf or hearing-impaired or epilepsy
• Infected patient or identified as carrier of an infectious agent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Hypnotic virtual reality support

Active Comparator group

Description:

Hypnotic virtual reality support using hypnosis software Hypno-VR® (Strasbourg, France) paired with VR headsets Oculus VR® (Menlo Park, CA, USA)

Treatment:

Device: Hypnotic virtual reality support using hypnosis software Hypno-VR®

Without hypnotic virtual reality support

Sham Comparator group

Treatment:

Device: No Hypnotic virtual reality