Patient Satisfaction
Conditions
Brief summary
A pilot non-randomized controlled study examined whether the use of VR technology can serve as an appropriate substitute for sedation in a colonoscopy examination.
Detailed description
VR is an attention-distracting technology via visual and auditory signals by a computer-generated virtual engulfing environment. This technology has already been used in a variety of medical conditions and previous studies have demonstrated the benefit of using it as an additional tool for pain relief and as a substitute to sedation in invasive procedure. In this study we examined the use of VR as a substitute for sedation in colonoscopy. In this randomized control study, 60 patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure. The primary outcome was the overall satisfaction of patients who underwent unsedated colonoscopy with VR headset compared with patients who underwent standard sedation colonoscopy. Pain during the procedure, PDR, colonoscopy duration, post colonoscopy adverse events, post colonoscopy recovery and time-to-return to daily functions and turnaround time at the endoscopy unit were secondary outcomes.
Interventions
DEVICEvirtual reality headset
use of virtual reality headset during colonoscopy as a substitute to sedation.
OTHERcolonoscopy with standard sedation.
use of standard sedation during colonoscopy.
Sponsors
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
pilot randomized controled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* adult patients (≥18) with any elective indication for colonoscopy.
Exclusion criteria
* known seizures' disorders, cognitive, visual or auditory impairment. * patients who were unable or unwilling to sign an informed consent. * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall satisfaction of patients who underwent un-sedated colonoscopy with virtual reality (VR) headset compared with patients who underwent standard sedation colonoscopy. | 1 day | Questionnaire (1 - not satisfied at all, 5 - very satisfied) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| polyp detection rate (PDR) | during colonoscopy procedure | number of polyps detected during colonoscopy |
| Colonoscopy duration | during colonoscopy procedure | in minutes starting at insertion of the colonoscope to the anus until final withdrawal |
| Pain during the procedure | 1 day | Questionnaire (1- severe pain, 5 - no pain at all) |
| Time-to-return to daily activities (work, driving) | 1 day | hours |
| Turn-around time at the endoscopy Unit (overall duration of stay at the Endoscopy unit) | 1 day | overall time at the unit |
| Post colonoscopy adverse events | 1 day | Questionnaire: Did you suffer from a general bad feeling after the test, including dizziness, nausea, abdominal pain (1 - no complaints at all, 5 - serious complaints) |
Countries
Israel
Contacts
Primary ContactIdo Veisman, Dr.
Backup ContactRevital Dvir, Mrs.
Outcome results
None listed