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Immersive Virtual Reality in Orthopedics

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05437796
Acronym
IVR-Ortho
Enrollment
80
Registered
2022-06-29
Start date
2020-01-01
Completion date
2023-10-02
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic, Virtual Reality

Keywords

Anxiety, Immersive virtual reality, Orthopedics, Pain

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.

Interventions

DEVICEHypnotic virtual reality support using hypnosis software Hypno-VR®

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

DEVICENo Hypnotic virtual reality

Group without Hypnotic virtual reality

Sponsors

Centre Hospitalier de Montauban
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of state of anxiety Spielberger60 minutesQuestionnaire 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.
Measurement of general anxiety Spielberger60 minutesQuestionnaire 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.

Secondary

MeasureTime frameDescription
Effectiveness of hypnotic virtual reality:48 hoursThe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026