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Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty (VR4POPKA)

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ClinicalTrials.gov Identifier: NCT03665233
Recruitment Status : Not yet recruiting
First Posted : September 11, 2018
Last Update Posted : July 31, 2019
Sponsor:
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
Dr. Arnaud Bosteels, Clinique Saint-Jean, Bruxelles

Brief Summary:
Virtual reality has been used for acute pain management (burn patients) with positive results. Hypnosis has known beneficial effects on patients in the peri-operative setting. The investigators are combining both by giving a virtual reality hypnosis (VRH) session to the patients during a known painful post-operative moment. (physiotherapy) It is the investigator intention to compare pain after physiotherapy during the first 3 days after a total knee arthroplasty, between 2 groups. One group , the VR group gets standard treatment with VRH and the second, the sham group, gets standard treatment with a sham VR session.

Condition or disease Intervention/treatment Phase
Virtual Reality Pain, Postoperative Knee Arthropathy Anesthesia Hypnosis Device: VR Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty: a Randomized, Controlled, Multi-center, Double Blind, Parallel Group, Superiority Trail to Evaluate VR as a Component of a Multi-modal Pain Treatment
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Sh-group
The patients in this arm get standard treatment, together with a sham version of a VR session.
Device: VR
People in the VR-group get a VRH session during the CPM physiotherapy , people in the sham group get a VR sham session, while they both can enjoy Standard Treatment
Other Names:
  • Aqua VRH session
  • Oncomfort
  • Gear VR

Active Comparator: VR-group
These patients get a VR session with the standard treatment
Device: VR
People in the VR-group get a VRH session during the CPM physiotherapy , people in the sham group get a VR sham session, while they both can enjoy Standard Treatment
Other Names:
  • Aqua VRH session
  • Oncomfort
  • Gear VR




Primary Outcome Measures :
  1. The comparison of opioid consumption after physiotherapy, when using VRH or VR sham [ Time Frame: on post operative day 1 ]
    After each physiotherapy session with continuous passive movement (CPM), a blinded investigator will measure the opioid consumption .

  2. The comparison of opioid consumption after physiotherapy, when using VRH or VR sham [ Time Frame: on post operative day 2 ]
    After each physiotherapy session with continuous passive movement (CPM), a blinded investigator will measure the opioid consumption

  3. The comparison of opioid consumption after physiotherapy, when using VRH or VR sham [ Time Frame: on post operative day 3 ]
    After each physiotherapy session with continuous passive movement (CPM), a blinded investigator will measure the opioid consumption


Secondary Outcome Measures :
  1. The change in anxiety measured with an anxiety scale, after physiotherapy, between the control (standard treatment ) and the VR group (standard + VR treatment) [ Time Frame: on post operative day (POD) 1-2-3 ]
    After each physiotherapy session with CPM, a blinded investigator will measure the anxiety using STAI Y. The State Trait Anxiety Inventory. This is a questionnaire of 20 questions assessing a patients state of anxiety. The answer to every questions can be rated from 1 until 4. The high rthe score the higher the anxiety.

  2. The variation in patient satisfaction at the end of the third day, between the participants using the VRH or not. [ Time Frame: on post operative day (POD) 3 ]
    after post operative day 3 a blinded investigator will measure the satisfaction score using (VAS) visual analogue scale. This is a scale going from no satisfaction at all until the best satisfaction one can imagine. The scale is like a horizontal yardstick with a cursor and the patient is asked to move to cursor to the level of his satisfaction. On the other side of the scale is a metric system from 0-10 cm. This way the satisfaction can be scored out of 10. The higher the number the better the satisfaction.

  3. The comparison in pain after post-operative physiotherapy using VAS [ Time Frame: on post operative day 1-2-3 ]
    a blinded investigator will measure the VAS pain score after each physiotherapy session involving a CPM.This is a scale going from no satisfaction at all until the best satisfaction one can imagine. The scale is like a horizontal yardstick with a cursor and the patient is asked to move to cursor to the level of his satisfaction. On the other side of the scale is a metric system from 0-10 cm. This way the pain can be scored out of 10. The higher the number the worser the pain

  4. The comparison of the evolution of the knee flexion with the CPM (Continuous passive motion) when using VRH or not [ Time Frame: on post operative day 1 and 3 ]
    Measure the increase of flexion of the knee on the CPM device between POD1 and POD3

  5. The variance in the length of stay after a total knee arthroplasty between the treatment and the control group. [ Time Frame: This will be assessed 1 week after surgery ]
    measuring the length of stay at the hospital, from the day (and hour) of surgery, until the patient is ready for discharge (day and hour). This is the moment the operator decides that the patient is fit enough to leave the hospital.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients having a TKA
  • General anesthesia and single shot fem block
  • Adults (> 18 years)
  • Elective procedures

Exclusion Criteria:

  • Refusal of consent
  • History of seizures
  • History of drug abuse
  • History of psychiatric diseases
  • Patients with impaired hearing
  • Patients with impaired vision
  • Patients afraid of submarine worlds
  • Chronic pain patients
  • Claustrophobia
  • Language not available on VR system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665233


Contacts
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Contact: Arnaud Bosteels, MD 221 97 62 ext 00 32 2 abosteels@clstjean.be

Locations
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Belgium
Clinique Saint Jean
Bruxelles, Belgium, 1000
Sponsors and Collaborators
Clinique Saint-Jean, Bruxelles
University Hospital, Antwerp
Investigators
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Principal Investigator: Arnaud Bosteels, MD Clinique Saint Jean Brussels

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Responsible Party: Dr. Arnaud Bosteels, Head of the anaesthesia department, principal investigator, Clinique Saint-Jean, Bruxelles
ClinicalTrials.gov Identifier: NCT03665233     History of Changes
Other Study ID Numbers: VRAB001
2018-001559-10 ( EudraCT Number )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Joint Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Musculoskeletal Diseases