Immersive Virtual Reality in Orthopedics

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using the Immersive Virtual Reality for the Management of Anxiety and Pain in Orthopedic Surgery

Conditions
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Virtual Reality, Orthopedic

Intervention / Treatment
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* Device: Hypnotic virtual reality support using hypnosis software Hypno-VR®
* Device: No Hypnotic virtual reality


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypnotic virtual reality support<br>Hypnotic virtual reality support using hypnosis software Hypno-VR® (Strasbourg, France) paired with VR headsets Oculus VR® (Menlo Park, CA, USA) | Device: Hypnotic virtual reality support using hypnosis software Hypno-VR®<br>* Hypnosis software Hypno-VR® (Strasbourg, France) paired with VR headsets Oculus VR® (Menlo Park, CA, USA)<br>* Other names: Hypnotic virtual reality;|
| Sham Comparator: Without hypnotic virtual reality support<br> | Device: No Hypnotic virtual reality<br>* Group without Hypnotic virtual reality<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of state of anxiety Spielberger | Questionnaire state of anxiety Spielberger: The Anxiety-State Scale assesses the feelings of apprehension, tension, nervousness and anxiety that the subject feels anxiety when the situation. The total score ranges from 20 - 80. The following guidelines are recommended for the interpretation of scores: Minus than 35 normal or no anxiety; 36 to 45, mild anxiety; 46 to 55, moderate anxiety; 56 to 65 severe anxiety; more than 65 severe anxiety. | 60 minutes | 
| Measurement of general anxiety Spielberger | Questionnaire general anxiety Spielberger: This questionnaire assesses your anxiety in life in general, and refers to trait anxiety. It is a stable disposition of personality. The total score ranges from 20 - 80. The following guidelines are recommended for the interpretation of scores: Minus than 35 normal or no anxiety; 36 to 45, mild anxiety; 46 to 55, moderate anxiety; 56 to 65 severe anxiety; more than 65 severe anxiety. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of hypnotic virtual reality: | The secondary objective of this research is to evaluate the effectiveness of hypnotic virtual reality: On pain using evaluation visual analog scale (VAS) pain, graduated from 0 to 10, measured in the first 48 hours after surgery On patient satisfaction using the Likert scale. The Likert scale is very popular and is often used in marketing research. It makes it possible to have nuances in the answers of respondents. Unlike scales dichotomous (yes / no), it makes it possible to have different degrees of judgment in analyzing the results. According to Likert, the most reliable measurement scales are those in seven ways: Not at all satisfied Unsatisfied Somewhat dissatisfied Neutral Rather satisfied Satisfied Very satisfied | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Immersive virtual reality, Orthopedics, Pain