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Integration of Virtual Reality as analgesia for office based flexible cystoscopy: a randomized prospective study

Effect of Virtual Reality as analgesia for office based flexible cystoscopy on procedural discomfort: a randomized prospective study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000534886
Enrollment
200
Registered
2021-05-06
Start date
2021-05-28
Completion date
2022-02-01
Last updated
2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Virtual reality has made an impact in areas of acute and chronic pain as an adjunct to standard analgesia regimes. Research has already shown benefit in areas of paediatric procedures, burn wound debridements and endoscopic gynaecological procedures to manage acute procedural pain. It appears subjective pain scores and anxiety levels may be reduced with this non-pharmacological approach This has not been introduced within the scope of urology procedures. Flexible cystoscopy is commonly carried out in the outpatient clinic under local anaesthetic. There wide variation in patients experience with this procedure, with a large number tolerating it poorly, which can also detract from the accuracy of the procedure. Integrating Virtual reality as an analgesia for office based flexible cystoscopy may improve patient satisfaction outcomes, and reduce numbers of patients requiring cystoscopy under General Anaesthesia. Aim: To determine if virtual reality technology will act as an analgesic aid to improve patient satisfaction following outpatient flexible cystoscopy. Method: This will be a single-centre, randomized prospective cohort study conducted within the Urology Department of Dunedin Hospital. Eligible participants will be patients who present for flexible cystoscopy in the outpatient setting. Patients with vision impairment or significant cognitive impairment will be excluded. Recruitment will be from the outpatient clinic over a 12-month period. Estimated sample size 200 patients. Patients will be consented then randomly allocated to Virtual Reality (VR) intervention group or control group. Routine flexible cystoscopy under local anaesthetic will take place with no procedural change in the way samples are collected in both groups. However, the intervention group will wear a VR headset with distraction environment VR software. They will then watch a VR movie for the duration of the procedure. Prior to the procedure in each group, Patients will complete a standardized questionnaire about their expectations of the procedure. This will include questions relating to pain, anxiety and overall expectation. After the procedure, patients will complete the same questionnaire investigating their pain, anxiety, VR response (if applicable) and overall satisfaction. The primary outcome will be patients’ pain, anxiety and overall satisfaction scores. This will be collected on standardized questionnaires as guided by similar international studies. Data will then be analysed to see if there is correlation between VR and primary outcome scores. All data collection will be anonymous with no identifiable information collected. No further follow up is required.

Interventions

Use of a virtual reality headset whilst undertaking office based flexible cystoscopy. Patients will wear a commercially available virtual reality headset for the duration of the procedure. They will receive a short tutorial on how to operate the headset prior to undergoing the procedure. Patient lie on a clinic bed whilst undergoing the procedure, in the outpatient clinic, which is standard practice. The procedure takes about 10 minutes. Patients will watch environmental scenery of a virtual sav

Use of a virtual reality headset whilst undertaking office based flexible cystoscopy. Patients will wear a commercially available virtual reality headset for the duration of the procedure. They will receive a short tutorial on how to operate the headset prior to undergoing the procedure. Patient lie on a clinic bed whilst undergoing the procedure, in the outpatient clinic, which is standard practice. The procedure takes about 10 minutes. Patients will watch environmental scenery of a virtual savannah type scene with varied flora and fauna to provide distraction, with natural sounds of these played through the headset. Once the procedure is complete the patient will remove the headset. The headset will be cleaned.

Sponsors

University Of Otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Undergoing flexible cystoscopy in the Urology outpatient clinic at Dunedin Hospital

Exclusion criteria

Patients with vision impairment or significant cognitive impairment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026