Hysteroscopy, Patient Satisfaction, Virtual Reality
Conditions
Keywords
Virtual Reality, Hysteroscopy, Iowa Satisfaction Scale, Sedation
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.
Interventions
DEVICEOculus Virtual Reality
The patient will receive standard care, augmented with virtual reality. Their post-operative satisfaction score will be recorded.
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Indications for hysteroscopy under RN-provided sedation
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 15 minutes post-operatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 10-point Likert Scale |
| Total Fentanyl dose | 45 minutes throughout the operation | Total IV Fentanyl dose in mcgs during the procedure |
| Total Midazolam dose | 45 minutes throughout the operation | Total IV Midazolam dose in mgs during the procedure |
| Occurrence of intraoperative hemodynamic changes | 45 minutes throughout the operation | Increase/decrease of 30 percent of SBP or HR compared to baseline |
| Incidence of early termination of VR experience | Noted during the procedure | Noting whether the patient decides to terminate the VR experience before the end of their procedure. |
| Proportion of patients wishing to use the technology again | Noted 15 minutes after the operation | Yes/No response |
| Immersion perception score of the VR system | 15 minutes after the operation. | 10 point Likert scale. On a 10 point Likert immersion scale (0-10) high scores are more immersed and low scores are less immersed. |
| Incidence of desaturation | 45 minutes throughout the operation | Pulse oxygen saturation \<90 percent |
Other
| Measure | Time frame | Description |
|---|---|---|
| Reason for early termination of VR experience | 45 minutes throughout the operation | Reasons may include: Patient desire/Medical decision/Nausea/Vomiting/Dizziness/ Headache/Device failure/ other |
Countries
Canada
Contacts
Primary ContactHelen K Parker, FRCA
Backup ContactCyrus Bhiladvala, B.Sc
Outcome results
None listed