Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty

NCT03665233 | Terminated

• 2 other identifiers: VRAB0012018-001559-10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Virtual Reality; Pain, Postoperative; Knee Arthropathy; Anesthesia; Hypnosis

Outcome Measures

Primary Outcomes (3)

• The comparison of opioid consumption after physiotherapy, when using VRH or VR sham

  After each physiotherapy session with continuous passive movement (CPM), a blinded investigator will measure the opioid consumption .

  on post operative day 1

• The comparison of opioid consumption after physiotherapy, when using VRH or VR sham

  After each physiotherapy session with continuous passive movement (CPM), a blinded investigator will measure the opioid consumption

  on post operative day 2

• The comparison of opioid consumption after physiotherapy, when using VRH or VR sham

  After each physiotherapy session with continuous passive movement (CPM), a blinded investigator will measure the opioid consumption

  on post operative day 3

Secondary Outcomes (5)

• The change in anxiety measured with an anxiety scale, after physiotherapy, between the control (standard treatment ) and the VR group (standard + VR treatment)

  on post operative day (POD) 1-2-3

• The variation in patient satisfaction at the end of the third day, between the participants using the VRH or not.

  on post operative day (POD) 3

• The comparison in pain after post-operative physiotherapy using VAS

  on post operative day 1-2-3

• The comparison of the evolution of the knee flexion with the CPM (Continuous passive motion) when using VRH or not

  on post operative day 1 and 3

• The variance in the length of stay after a total knee arthroplasty between the treatment and the control group.

  This will be assessed 1 week after surgery

Study Arms (2)

Sh-group

SHAM COMPARATOR

The patients in this arm get standard treatment, together with a sham version of a VR session.

Device: VR

VR-group

ACTIVE COMPARATOR

These patients get a VR session with the standard treatment

Device: VR

Interventions

VR DEVICE

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

Also known as: Aqua VRH session, Oncomfort, Gear VR

Sh-group; VR-group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Saint-Jean, Bruxelles: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

Clinique Saint Jean

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Arnaud Bosteels, MD

  Clinique Saint Jean Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the anaesthesia department, principal investigator

Study Record Dates

• First Submitted: September 2, 2018
• First Posted: September 11, 2018
• Study Start: September 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: November 30, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)