Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202308639904589 Date of Approval: 24/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Virtual reality during loco regional anesthesia for knee arthroplasty
Official scientific title Impact of intraoperative virtual reality in patients undergoing Knee arthroplasty under spinal anesthesia: a randomized controlled trial.
Brief summary describing the background and objectives of the trial Virtual Reality is a set of technological hardware that allows individuals to interact with a virtual environment using their natural senses and skills. This immersion is generally carried out by means of a helmet of tereoscopic vision or a helmet coupled to a position tracker. Thanks to its immersive characteristics, it is currently included in the therapeutic arsenal for both acute and chronic pain. Its anxiolytic and analgesic effects are beginning to be evaluated in the perioperative setting, as a non-pharmacological adjunct to anesthesia. When used in combination with loco-regional anesthesia or patient-controlled sedation, it may improve the quality of analgesia, reduce anxiety and stress levels, improve patient satisfaction and reduce r anesthetic and analgesic requirements. The aim of the study is to assess the impact of intraoperative virtual reality in patients undergoing Knee arthroplasty under spinal anesthesia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2022
Actual trial start date 15/02/2022
Anticipated date of last follow up 30/09/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 66
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group VR intraoperatively virtual reality session containing 360° videos in different touristic cities via VR mask 33
Control Group Group No VR Intraoperatively No Intraoperatively VR 33 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Age 18 years or more • ASA I or II • Acceptance to participate to the study • Patients who had an intra operative incident (bleeding, bronchospasm, anaphylaxis) • Patients who needed a conversion to general anesthesia • Patients who required a transfer to intensive care unit • Visual and auditory impairments • History of epilepsy • Cognitive disorders • Contraindications to spinal anesthesia • Ambulatory surgery • Neuropsychiatric disorders • Analgesics chronic use Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/05/2022 Ethics committee of faculty of medecine of Sousse
Ethics Committee Address
Street address City Postal code Country
Rue Mohamed Karoui Sousse 4002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Patient satisfaction - likert scale At the end of surgery, 24 hours postoperatively
Secondary Outcome post operative opioids requirements 24 hours postoperatively
Secondary Outcome Time to rescue analgesia postoperatively
Secondary Outcome Post operative Pain intensity- Visual Analogue scale every 4 hours during the first 24 postoperative hours
Secondary Outcome Hemodynamic stability Intraoperatively, during the first 24 hours postoperatively
Secondary Outcome postoperative ambulation time to the first postoperative ambulation
Secondary Outcome Quality of rehabilitation- QoR40 24 hours postoperatively
Secondary Outcome Length of hospital stay time to hospital discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Sahloul Teachnig Hospital Route de la ceinture Sousse 4011 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
SAhloul Teaching Hospital Route de la ceinture Sousse 4011 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Sahloul Teaching Hospital Route de la ceinture Sousse 4011 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Kahloul med.kahloul@outlook.fr +21623567317 Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
Role Name Email Phone Street address
Principal Investigator Rami Ayadi med_rami.1309@yahoo.fr +21650372003 Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Walid Naija walidnaija@yahoo.fr +21696162001 Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
Role Name Email Phone Street address
Public Enquiries Ajmi Chaouch ajmichaouch@yahoo.fr +21629848655 Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
Role Name Email Phone Street address
Scientific Enquiries Karim Bouattour kbouattourfr@yahoo.fr +21698462512 Sahloul
City Postal code Country Position/Affiliation
Sousse 4011 Tunisia Sahloul Teaching Hospital Faculty of medecine of Sousse
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available. It will include the entire individual participant data collected during the trial, after deidentification. The study protocol, the statistical analysis plan, the informed consent form and the clinical study report will also be available. All these documents will be shared with researchers who provide a methodologically sound proposal, for any purpose. Proposals should be directed to med.kahloul@outlook.fr. To gain access, data requestors will need to sign a data access agreement. Informed Consent Form,Statistical Analysis Plan,Study Protocol IPD will be shared during a 24-month period, beginning 9 months after article publication. Virtual reality, Operating room, loco regional anesthesia, Anxiety, Analgesia
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information