Clinical trial NCT04862598: Virtual Reality to Improve Satisfaction in Hysteroscopy Patients
Official title: Virtual Reality to Improve Satisfaction in Patients Undergoing Hysteroscopy: A Single-centre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Satisfaction
Virtual Reality
Hysteroscopy
Keywords: Virtual Reality
Hysteroscopy
Iowa Satisfaction Scale
Sedation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 192
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 15 minutes post-operatively
Secondary outcomes:
measure: Patient anxiety scores before and after the procedure
timeFrame: 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.
measure: Total Fentanyl dose
timeFrame: 45 minutes throughout the operation
measure: Total Midazolam dose
timeFrame: 45 minutes throughout the operation
measure: Occurrence of intraoperative hemodynamic changes
timeFrame: 45 minutes throughout the operation
measure: Incidence of desaturation
timeFrame: 45 minutes throughout the operation
measure: Incidence of early termination of VR experience
timeFrame: Noted during the procedure
measure: Proportion of patients wishing to use the technology again
timeFrame: Noted 15 minutes after the operation
measure: Immersion perception score of the VR system
timeFrame: 15 minutes after the operation.
Other outcomes:
measure: Reason for early termination of VR experience
timeFrame: 45 minutes throughout the operation
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Anton Chau, MD
role: PRINCIPAL_INVESTIGATOR
References: