Virtual Reality to Improve Satisfaction in Hysteroscopy Patients
VIP
1 other identifier
interventional
192
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2021
CompletedStudy Start
First participant enrolled
March 24, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedOctober 7, 2021
September 1, 2021
1.2 years
February 23, 2021
September 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Satisfaction
Change in post-procedure patient satisfaction score (Iowa Satisfaction Scale) of at least 0.6 between the Virtual Reality group and the control group. High scores are better than low scores which are worse. Scores range from -3 (completely unsatisfied) to 3 (completely satisfied)
15 minutes post-operatively
Secondary Outcomes (8)
Patient anxiety scores before and after the procedure
30 minutes before operation (one anxiety score). 15 minutes after operation (one anxiety score). On a 10 point Likert anxiety scale (0-10) high scores are more anxious and low scores are less anxious.
Total Fentanyl dose
45 minutes throughout the operation
Total Midazolam dose
45 minutes throughout the operation
Occurrence of intraoperative hemodynamic changes
45 minutes throughout the operation
Incidence of desaturation
45 minutes throughout the operation
- +3 more secondary outcomes
Other Outcomes (1)
Reason for early termination of VR experience
45 minutes throughout the operation
Study Arms (2)
Control
NO INTERVENTIONThe patient will be positioned on the operating table and have routine monitoring attached (ECG, blood pressure, O2 saturations, end tidal carbon dioxide monitoring (ETCO2). A surgical safety time out will be performed. The patient will receive routine operative and nursing care. The study team member will record highest and lowest heart rate and blood pressure as well as lowest O2 saturation and the total intra-operative dose of fentanyl and midazolam administered to the patient. At the end of the procedure, the patient is assisted into a wheelchair and will return to the recovery area. After 15 minutes of recovery, a member of the study team will give them the post-operative questionnaires which will consist of answering how anxious they felt during the procedure and the 11 question Iowa Satisfaction with Anesthesia scale (ISAS). The patient will then be free to leave once they have met the standard discharge criteria.
VR Group
EXPERIMENTALThe patient wears the VR headset after being positioned on the table and the surgical time out has been completed. The VR scene and accompanying music will continue until the end of the procedure or until the patient wishes for it to be removed. The patient will receive standard operative and nursing care. The study team member will record the intra-operative vitals as detailed in the control group procedure. At the end of the procedure, the patient will be moved to recovery and will receive standard care. At 15 minutes, they will be provided with the anxiety questionnaire and the ISAS. Additional questions will be asked; their level of VR immersion and if they would like to receive the VR technology again if they were to undergo another procedure in the future. They will then be free to leave once they have met the standard discharge criteria.
Interventions
The patient will receive standard care, augmented with virtual reality. Their post-operative satisfaction score will be recorded.
Eligibility Criteria
You may qualify if:
- Indications for hysteroscopy under RN-provided sedation
You may not qualify if:
- Inability to provide informed consent to participate in the study (e.g. significant language barrier)
- Severe cognitive impairment
- Chronic benzodiazepine use
- Chronic opioid use
- Presence or history of psychotic psychiatric disorders
- Presence or history of seizure disorders
- Visual acuity \<1 with correction
- Hearing impairment requiring correction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
BC Women's Hospital
Vancouver, British Columbia, V6H4J4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anton Chau, MD
University of British Columbia
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical assistant professor
Study Record Dates
First Submitted
February 23, 2021
First Posted
April 28, 2021
Study Start
March 24, 2021
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
October 7, 2021
Record last verified: 2021-09