Clinical trial NCT05437796: Immersive Virtual Reality in Orthopedics
Official title: Using the Immersive Virtual Reality for the Management of Anxiety and Pain in Orthopedic Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Virtual Reality
Orthopedic
Keywords: Anxiety
Immersive virtual reality
Orthopedics
Pain
Lead sponsor: Centre Hospitalier de Montauban
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of state of anxiety Spielberger
timeFrame: 60 minutes
measure: Measurement of general anxiety Spielberger
timeFrame: 60 minutes
Secondary outcomes:
measure: Effectiveness of hypnotic virtual reality:
timeFrame: 48 hours
Other outcomes:
Locations:
city: Montauban
country: France
facility: Edmundo Pereira de Souza Neto
state: Tarn Et Garonne
Study officials:
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