Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393556
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-04-26
Brief Title:
VR for the Reduction of Perioperative Anxiety
Sponsor:
Ruhr University of Bochum
Organization:
Ruhr University of Bochum
Study Overview
Official Title:
Assessment and Minimization of Preoperative Fear of the Unknown Using a VR Experience of the Theatre Suite a Randomized Control Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study set to take place at Gold Coast University Hospital in Australia will be conducted as a randomized controlled trial Patients preparing for gynecological cancer surgery will be recruited and randomly assigned to one of two groups those who will receive standard care plus a virtual reality VR intervention and those who will receive only standard care Standard care encompasses the usual pre-operative procedures and support provided by the hospital staff
We hypothesize that immersing patients in a preparatory virtual environment that shows them what they are to expect during their upcoming hospital stay for surgery could help reduce their anxiety levels
We hypothesize that immersing patients in a preparatory virtual environment that shows them what they are to expect during their upcoming hospital stay for surgery could help reduce their anxiety levels
Detailed Description:
The study objective is to determine whether exposure to the operating theatre suite via virtual reality VR for patients undergoing gynecologic-oncological surgery reduces pre-operative anxiety
After patients are recruited their anxiety level is measured by a simple 6-item visual anxiety scale T0 Patients are then randomized into either receiving care-as-usual CAU or CAU combined with a VR experience 35 minutes with background music and narration where they are familiarized with the environment they will encounter during their stay for their cancer operation Anxiety is measured again T1 Daysweeks later when patients are back in the hospital for their surgery T2 anxiety is measured again in the preanesthetic bay before receiving any anesthetics Personnel collecting the anxiety scale at T2 will be unaware whether a patient had received the VR intervention or not
Randomization will be performed by a person unrelated to the study by using a computerized randomization tool to generate an allocation list and inserting paper slips with the group allocation into consecutively numbered opaque envelopes which are opened in order at the time of randomization
Using a two-sided Wilcoxon-Mann-Whitney test and targeting a power of 80 at a significance level α of 005 abd assuming a clinically relevant difference in the anxiety scale of at least one face ie at least 1 point on the 6-item scale between the two groups and a within-group standard deviation of 16 effect size 0625 sample size was determined as 34 patients per group for a 11 group allocation Assuming a drop outlost-to-follow up rate of up to 15 80 patients 40 per group are to be recruited
Descriptive statistic analysis will be performed Within-group and between-group assessements will be done using Wilcoxon signed rank test and the Mann-Whitney rank sum test respectively
After patients are recruited their anxiety level is measured by a simple 6-item visual anxiety scale T0 Patients are then randomized into either receiving care-as-usual CAU or CAU combined with a VR experience 35 minutes with background music and narration where they are familiarized with the environment they will encounter during their stay for their cancer operation Anxiety is measured again T1 Daysweeks later when patients are back in the hospital for their surgery T2 anxiety is measured again in the preanesthetic bay before receiving any anesthetics Personnel collecting the anxiety scale at T2 will be unaware whether a patient had received the VR intervention or not
Randomization will be performed by a person unrelated to the study by using a computerized randomization tool to generate an allocation list and inserting paper slips with the group allocation into consecutively numbered opaque envelopes which are opened in order at the time of randomization
Using a two-sided Wilcoxon-Mann-Whitney test and targeting a power of 80 at a significance level α of 005 abd assuming a clinically relevant difference in the anxiety scale of at least one face ie at least 1 point on the 6-item scale between the two groups and a within-group standard deviation of 16 effect size 0625 sample size was determined as 34 patients per group for a 11 group allocation Assuming a drop outlost-to-follow up rate of up to 15 80 patients 40 per group are to be recruited
Descriptive statistic analysis will be performed Within-group and between-group assessements will be done using Wilcoxon signed rank test and the Mann-Whitney rank sum test respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None