Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862598
Status:
UNKNOWN
Last Update Posted:
2021-10-07
First Post:
2021-02-23
Brief Title:
Virtual Reality to Improve Satisfaction in Hysteroscopy Patients
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Virtual Reality to Improve Satisfaction in Patients Undergoing Hysteroscopy A Single-centre Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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:
VIP
Brief Summary:
This study aims to investigate whether viewing an immersive virtual reality VR image through a VR headset during elective hysteroscopy under Registered Nurse RN led sedation with fentanyl and midazolam plus local anesthesia monitored anesthetic care will improve patient satisfaction with their anesthesia Patients will be randomized to either receive usual care or usual care plus VR Satisfaction will be measured by asking patients to complete a post-procedure survey consisting of 11 questions
Detailed Description:
Purpose To determine whether viewing an immersive VR image viewed over an Oculus Quest VR headset during hysteroscopy can improve patient satisfaction with their anesthesia sedation plus local anesthesia The VR image used in the study is Cosmic Flow A Relaxing VR experience which is freely available from Oculus The patient will also wear headphones during the study which will play relaxing meditation music
Hypothesis The use of immersive VR during elective hysteroscopy under sedation will improve patient satisfaction with their anesthesia by at least 20 measured using the Iowa Satisfaction with Anesthesia Scale
Justification Ambulatory hysteroscopy is conducted under general anesthesia or in the established Procedural Sedation Program The latter involves Registered Nurse RN led sedation consisting of the administration of sedation midazolam and analgesia fentanyl to reduce discomfort and anxiety However these medications have unwanted side-effects such as over-sedation and nausea which can delay discharge and reduce patient satisfaction with their procedure To minimize these complications non-pharmacological therapy is of interest as it aims to reduce the need and dosage of these medications Virtual reality is one such non-pharmacological intervention which has been trialled in several settings and has been shown to have beneficial effects on pain and anxiety during procedures such as wound dressing changes upper GI endoscopies and dental procedures Virtual reality use in the healthcare setting is currently in an early phase of research and more study is needed on effects of VR on precise outcomes such as patient satisfaction which is an important marker for quality in healthcare
Objectives The objective is to study patient reported satisfaction with their anesthesia sedation plus local anesthesia when they receive standard care to when they receive standard care plus viewing an immersive VR image during their hysteroscopy procedure
Research Design This is a randomized controlled trial involving data collection before during and after the hysteroscopy procedure
Statistical Analysis The primary outcome in change in patient satisfaction scores will be compared using paired t-test For secondary outcomes all continuous data will be compared using t-test or Mann-Whitney U test as appropriate Incidence and proportion outcomes will be analyzed using Fisher exact test
Hypothesis The use of immersive VR during elective hysteroscopy under sedation will improve patient satisfaction with their anesthesia by at least 20 measured using the Iowa Satisfaction with Anesthesia Scale
Justification Ambulatory hysteroscopy is conducted under general anesthesia or in the established Procedural Sedation Program The latter involves Registered Nurse RN led sedation consisting of the administration of sedation midazolam and analgesia fentanyl to reduce discomfort and anxiety However these medications have unwanted side-effects such as over-sedation and nausea which can delay discharge and reduce patient satisfaction with their procedure To minimize these complications non-pharmacological therapy is of interest as it aims to reduce the need and dosage of these medications Virtual reality is one such non-pharmacological intervention which has been trialled in several settings and has been shown to have beneficial effects on pain and anxiety during procedures such as wound dressing changes upper GI endoscopies and dental procedures Virtual reality use in the healthcare setting is currently in an early phase of research and more study is needed on effects of VR on precise outcomes such as patient satisfaction which is an important marker for quality in healthcare
Objectives The objective is to study patient reported satisfaction with their anesthesia sedation plus local anesthesia when they receive standard care to when they receive standard care plus viewing an immersive VR image during their hysteroscopy procedure
Research Design This is a randomized controlled trial involving data collection before during and after the hysteroscopy procedure
Statistical Analysis The primary outcome in change in patient satisfaction scores will be compared using paired t-test For secondary outcomes all continuous data will be compared using t-test or Mann-Whitney U test as appropriate Incidence and proportion outcomes will be analyzed using Fisher exact test
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