Virtual Reality Hypnosis in Total Knee Arthroplasty Under Spinal Anesthesia

NCT05707234 | Completed Phase 4

• 1 other identifier: VRH.TKA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

For many years, total knee arthroplasty (TKA) has been a common and effective procedure to treat chronic refractory joint pain. Although efforts must be pursued, as general anesthesia remains the main tendency for TKA. Currently, the standard of care to manage procedural anxiety is pharmacological sedation; i.e. the intravenous administration of additional anesthetic agents such as propofol or midazolam. However, pharmacological sedation has considerable undesirable side effects. Hence, risks of intraprocedural adverse events including respiratory depression, hemodynamic perturbations, or paradoxical effects such as hostility, aggression, and psychomotor agitation, are increased. The goal of this prospective, single-center, randomized controlled clinical trial is to systematically evaluate the impact of implementing a protocol of virtual reality hypnosis in patients undergoing total knee arthroplasty under spinal anesthesia.

Conditions

Arthroplasty Complications; Knee Osteoarthritis; Anesthesia Complication; Hypnotic; Anxiety Disorder; Sedation Complication

Outcome Measures

Primary Outcomes (1)

• Midazolam milligrams

  Sedation: Intravenous milligrams of midazolam administered during first 120 minutes of surgery to achieve a RASS (Richmond Agitation-Sedation Scale) of -2 or -3.

  2 hours

Secondary Outcomes (12)

• Intensity of postoperative pain

  1 hour, 24 hours, 48 hours after surgery and one week later

• Anxiety

  1 hour, 24 hours, 48 hours after surgery and one week later

• Anxiety

  1 hour, 24 hours, 48 hours after surgery and one week later

• Comfort

  1 hour, 24 hours, 48 hours after surgery and one week later

• Fatigue

  1 hour, 24 hours, 48 hours after surgery and one week later

Other Outcomes (1)

• Length of Stay

  7 days after surgery

Study Arms (2)

Control Group

ACTIVE COMPARATOR

During the procedure, the patient in the control group receives pharmacological sedation, which is the standard of care currently practiced. Such sedation allows intraoperative anxiolysis, which is constantly required by patients in order to dissociate from their surroundings. Recall that total knee replacement surgery is extremely noisy, and the surrounding environment is itself an anxiety-provoking factor for the patient. Light to moderate, intraoperative sedation is carried out by intermittent boluses of midazolam 1 mg IV. Boluses are given every 5 minutes until a sedation level of -2 or -3 on the RASS (Richmond Agitation-Sedation Scale) scale is reached. Patients randomized to the control group will undergo perioperative anesthesia according to the current standards of care, without the addition of the VR headset or headphones.

Drug: Midazolam sedation

VRH Group

EXPERIMENTAL

They will experience an underwater experience while listening to hypnotic script designed to induce a change in state of consciousness, increasing parasympathetic system tone and relaxation response, and reducing the perception of painful stimuli. During the whole procedure, an anesthesiologist will perform the usual cares, including closely monitoring, and will administrate intravenous sedation (midazolam) when necessary (see sedation protocol in the previous section).

Device: VRH; Drug: Midazolam sedation

Interventions

VRH DEVICE

The VR headset and headphones will be placed on patients after the spinal anesthesia, once the patient is positioned and the surgical drapes installed. Patients will then undergo a 120-minute Digital Sedation™ program (Aqua+© 120 Version 1.1 or subsequent version, Oncomfort SA, Waver, Belgium). They will experience an underwater experience while listening to hypnotic script designed to induce a change in state of consciousness, increasing parasympathetic system tone and relaxation response, and reducing the perception of painful stimuli. While the session is running, HCPs can see what is projected into the VRH headset on their Sedakit's X2 controller (i.e. the tablet connected to the glasses).

VRH Group

Midazolam sedation DRUG

During the procedure, the patient in the control group receives pharmacological sedation, which is the standard of care currently practiced. Such sedation allows intraoperative anxiolysis, which is constantly required by patients in order to dissociate from their surroundings. Recall that total knee replacement surgery is extremely noisy, and the surrounding environment is itself an anxiety-provoking factor for the patient. Light to moderate, intraoperative sedation is carried out by intermittent boluses of midazolam 1 mg IV. Boluses are given every 5 minutes until a sedation level of -2 or -3 on the RASS (Richmond Agitation-Sedation Scale) scale is reached.

Control Group; VRH Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \>18 yo and scheduled for elective knee arthroplasty under spinal anesthesia

You may not qualify if:

• Low auditory and/or visual acuity that precludes the use of the device.
• ASA status \> 3
• Head or face wounds precluding use of the device.
• Schizophrenia or dissociative disorder.
• Pregnancy.
• Chronic renal insufficiency or severe hepatic insufficiency.
• Non-proficiency in French (Research language).
• Phobia of deep water.
• Chronic pain and/or chronic analgesics consumption.
• Medication affecting the autonomic nervous system.
• Revision surgery.
• Dizziness.

Sponsors & Collaborators

• University of Liege: lead

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

Location

Related Publications (1)

• Carella M, Beck F, Quoilin C, Azongmo MM, Loheac A, Bonhomme VL, Vanhaudenhuyse A. Effect of virtual reality hypnosis on intraoperative sedation needs and functional recovery in knee arthroplasty: a prospective randomized clinical trial. Reg Anesth Pain Med. 2025 May 6;50(5):383-389. doi: 10.1136/rapm-2023-105261.

  PMID: 38413184 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Anxiety Disorders

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Clinic

Model Details: prospective, single-center, randomized controlled clinical trial

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 31, 2023
• Study Start: February 15, 2023
• Primary Completion: August 3, 2023
• Study Completion: August 3, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)