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Trial registered on ANZCTR


Registration number
ACTRN12618001296224
Ethics application status
Approved
Date submitted
30/07/2018
Date registered
1/08/2018
Date last updated
1/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Virtual Reality Therapy and Patient Controlled Sedation in Joint Replacement Surgery
Scientific title
Effects of Immersive Virtual Reality Therapy on Intravenous Patient Controlled Sedation During Orthopedic Surgery Under Regional Anesthesia
Secondary ID [1] 295694 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
joint replacement 309069 0
sedation 309070 0
Analgesia 309071 0
Condition category
Condition code
Anaesthesiology 307954 307954 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Providing patients with a set of virtual reality goggles, either Samsung Gear VR, or Oculus Rift DK2 goggles playing simulations of floating down scenic outdoor vistas. On the Gear VR this was EdenRiver 1.0 by Unello Design, and on the Oculus Rift DK2 this was Iceland by VergeVR.

Intervention lasted to the end of the procedure, or to when the patient self-removed the IVR therapy.

This occurred in the operating theatres at St Vincent's Hospital, Melbourne.

The principal investigator, Mark Huang, administered the treatment, in conjunction of the list anaesthetist.

Adherence was monitored by watching the patient for any discomfort, and any attempts at removal were documented.

Sedation administered was the same in the intervention/control arm:

Regional anaesthesia for all patients was performed by the Anaesthesiologist. Between 2.8 and 3.4 ml of 0.5% Bupivacaine was injected into the L4-L5 subarachnoid space. For knee replacements, a popliteal nerve block was administered using 20ml of 0.2% ropivicaine and a femoral nerve catheters were inserted, with the patient receiving 20ml of 0.375% ropivicaine. Each patient was given a patient controlled sedation (PCS) button, with each press of the PCS supplying a propofol bolus of 400mcg/kg Ideal Body Weight with a 5 minute lockout period. The anaesthetist was also permitted to give adjuvant fentanyl or midazolam as he/she felt fit.
Intervention code [1] 302011 0
Treatment: Devices
Comparator / control treatment
Sedation/analgesia was the same as the intervention arm

Regional anaesthesia for all patients was performed by the Anaesthesiologist. Between 2.8 and 3.4 ml of 0.5% Bupivacaine was injected into the L4-L5 subarachnoid space. For knee replacements, a popliteal nerve block was administered using 20ml of 0.2% ropivicaine and a femoral nerve catheters were inserted, with the patient receiving 20ml of 0.375% ropivicaine. Each patient was given a patient controlled sedation (PCS) button, with each press of the PCS supplying a propofol bolus of 400mcg/kg Ideal Body Weight with a 5 minute lockout period. The anaesthetist was also permitted to give adjuvant fentanyl or midazolam as he/she felt fit.
Control group
Active

Outcomes
Primary outcome [1] 306929 0
Dosage of propofol was recorded directly from the patient controlled sedation machine at the end of the case (Alaris pump, BD, Franklin Lakes NJ, USA). Time of the case was also recorded from the PCA pump.
Timepoint [1] 306929 0
End of procedure
Secondary outcome [1] 350146 0
Mean adjuvant sedation used - recorded from the anaesthetic record and on a separate datasheet by hand when the bedside anaesthetist administered an additional agent
Timepoint [1] 350146 0
Before, during, and at the end of the procedure
Secondary outcome [2] 350205 0
Quality of Recovery Survey/Subjective responses -Patient experience was assessed using a Quality of Recovery Survey (QoR-40). The QoR-40 includes questions regarding patient comfort, emotional state, symptoms and pain rated on a 1-5 scale, where 1 means “never” and 5 means “all the time”. In addition, subjects were asked if they were satisfied with their experience, and if they would be willing to undergo future invasive surgeries using IVR.
Timepoint [2] 350205 0
End of case
Secondary outcome [3] 350206 0
Propofol demands and delivery during the case - recorded from the PCS machine and separated by hour
Timepoint [3] 350206 0
End of case

Eligibility
Key inclusion criteria
All patients undergoing elective knee or hip joint replacement surgery under regional anesthesia. English-speaking patients 18 years of age with and over no significant cardiovascular or respiratory disease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving general anesthesia, cognitive impairment preventing the use of subjective outcome surveys, visual or hearing impairment and non-English speaking patients.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software - random number generation corresponding to treatment or control arm
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data were analyzed by intention to treat.
Propofol use comparison via one-way ANOVA comparing means.
Fisher’s Exact test and the Mann Whitney U test for the comparison of categorical and continuous non-parametric variables respectively.
Independent association between the measured variables and propofol use using the Mann Whitney U-test for categorical variables (including pre-procedure QoR-40 scores), Pearson’s correlation coefficient for continuous variables. QoR-40 score changes from pre- to post-procedure using the Mann Whitney U test.
Post-hoc negative binomial regression to assess for potential confounders

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/02/2016
Date of last participant enrolment
Anticipated
Actual
10/05/2016
Date of last data collection
Anticipated
Actual
13/05/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 300278 0
Hospital
Name [1] 300278 0
St Vincents Hospital
Country [1] 300278 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital Research Endowment Fund
Address
41 Victoria Parade
Fitzroy VIC
3065
Country
Australia
Secondary sponsor category [1] 299708 0
None
Name [1] 299708 0
Address [1] 299708 0
Country [1] 299708 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301091 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 301091 0
Ethics committee country [1] 301091 0
Australia
Date submitted for ethics approval [1] 301091 0
Approval date [1] 301091 0
21/10/2015
Ethics approval number [1] 301091 0
LRR 142/15

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2926 2926 0 0
/AnzctrAttachments/375699-Manuscript_Final_1.0.docx (Publication)
Attachments [2] 2927 2927 0 0
/AnzctrAttachments/375699-LRR application Chan - PCA and IVR v2.docx (Protocol)
Attachments [3] 2928 2928 0 0
/AnzctrAttachments/375699-PICF Chan - PCA and IVR v2 clean.docx (Participant information/consent)
Attachments [4] 2933 2933 0 0
/AnzctrAttachments/375699-LRR 142.15 - Final Approval.pdf (Ethics approval)

Contacts
Principal investigator
Name 85854 0
Dr Peter Chan
Address 85854 0

Box Hill Hospital
Intensive Care Services
7 Arnold Street
Box Hill VIC
3128
Country 85854 0
Australia
Phone 85854 0
+61422525247
Fax 85854 0
Email 85854 0
peter.chan@easternhealth.org.au
Contact person for public queries
Name 85855 0
Peter Chan
Address 85855 0

Box Hill Hospital
Intensive Care Services
7 Arnold Street
Box Hill VIC
3128
Country 85855 0
Australia
Phone 85855 0
+61422525247
Fax 85855 0
Email 85855 0
peter.chan@easternhealth.org.au
Contact person for scientific queries
Name 85856 0
Peter Chan
Address 85856 0

Box Hill Hospital
Intensive Care Services
7 Arnold Street
Box Hill VIC
3128
Country 85856 0
Australia
Phone 85856 0
+61422525247
Fax 85856 0
Email 85856 0
peter.chan@easternhealth.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffects of immersive virtual reality therapy on intravenous patient-controlled sedation during orthopaedic surgery under regional anesthesia: A randomized controlled trial.2020https://dx.doi.org/10.1371/journal.pone.0229320
N.B. These documents automatically identified may not have been verified by the study sponsor.