Immersive Virtual Reality in Orthopedics

NCT05437796 | Unknown

• 1 other identifier: 2020-A00005-34
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Orthopedic

Keywords

Anxiety; Immersive virtual reality; Orthopedics; Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effectiveness of hypnotic virtual reality:

  48 hours

Study Arms (2)

Hypnotic virtual reality support

ACTIVE COMPARATOR

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®

Without hypnotic virtual reality support

SHAM COMPARATOR

Device: No Hypnotic virtual reality

Interventions

Hypnotic virtual reality support using hypnosis software Hypno-VR® DEVICE

Hypnosis software Hypno-VR® (Strasbourg, France) paired with VR headsets Oculus VR® (Menlo Park, CA, USA)

Also known as: Hypnotic virtual reality

Hypnotic virtual reality support

No Hypnotic virtual reality DEVICE

Group without Hypnotic virtual reality

Without hypnotic virtual reality support

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Montauban: lead

Study Sites (1)

Edmundo Pereira de Souza Neto

Montauban, Tarn Et Garonne, 82000, France

RECRUITING

Related Publications (17)

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  PMID: 20737029 BACKGROUND

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  PMID: 18558145 BACKGROUND

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  PMID: 4688678 BACKGROUND

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• Williamson A. What is hypnosis and how might it work? Palliat Care. 2019 Jan 31;12:1178224219826581. doi: 10.1177/1178224219826581. eCollection 2019. No abstract available.

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  PMID: 31047650 BACKGROUND

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• Gumaa M, Rehan Youssef A. Is Virtual Reality Effective in Orthopedic Rehabilitation? A Systematic Review and Meta-Analysis. Phys Ther. 2019 Oct 28;99(10):1304-1325. doi: 10.1093/ptj/pzz093.

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• Negrillo-Cardenas J, Jimenez-Perez JR, Feito FR. The role of virtual and augmented reality in orthopedic trauma surgery: From diagnosis to rehabilitation. Comput Methods Programs Biomed. 2020 Jul;191:105407. doi: 10.1016/j.cmpb.2020.105407. Epub 2020 Feb 21.

  PMID: 32120088 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 29, 2022
• Study Start: January 1, 2020
• Primary Completion: October 2, 2023
• Study Completion: October 2, 2023
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)