Virtual Reality to Improve Satisfaction in Hysteroscopy Patients

Patient Satisfaction Clinical Trial

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Official title:

Virtual Reality to Improve Satisfaction in Patients Undergoing Hysteroscopy: A Single-centre Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04862598
• Other study ID #: H20-03663
• Status: Recruiting
• Phase: N/A
• Start date: March 24, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2021
• Source: University of British Columbia
• Contact: Helen K Parker, FRCA
• Phone: 6048752158
• Email: helenkparker22[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hysteroscopy
• Patient Satisfaction
• Virtual Reality

Intervention

Device:
• Oculus Virtual Reality
The patient will receive standard care, augmented with virtual reality. Their post-operative satisfaction score will be recorded.

Locations

Country	Name	City	State
Canada	BC Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reason for early termination of VR experience	Reasons may include: Patient desire/Medical decision/Nausea/Vomiting/Dizziness/ Headache/Device failure/ other	45 minutes throughout the operation
Primary	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	Patient anxiety scores before and after the procedure	10-point Likert Scale	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.
Secondary	Total Fentanyl dose	Total IV Fentanyl dose in mcgs during the procedure	45 minutes throughout the operation
Secondary	Total Midazolam dose	Total IV Midazolam dose in mgs during the procedure	45 minutes throughout the operation
Secondary	Occurrence of intraoperative hemodynamic changes	Increase/decrease of 30 percent of SBP or HR compared to baseline	45 minutes throughout the operation
Secondary	Incidence of desaturation	Pulse oxygen saturation <90 percent	45 minutes throughout the operation
Secondary	Incidence of early termination of VR experience	Noting whether the patient decides to terminate the VR experience before the end of their procedure.	Noted during the procedure
Secondary	Proportion of patients wishing to use the technology again	Yes/No response	Noted 15 minutes after the operation
Secondary	Immersion perception score of the VR system	10 point Likert scale. On a 10 point Likert immersion scale (0-10) high scores are more immersed and low scores are less immersed.	15 minutes after the operation.