Trial · NCT07884851
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Enrollment Rate | Throughout the enrollment period (approximately 8 weeks) | Proportion of eligible patients approached who provide written informed consent, calculated as the number consented divided by the number eligible and approached. Pre-specified feasibility benchmark: enrollment rate of 60% or greater. |
| Primary | Virtual Reality Setup Time | Day 1, from headset placement (after the pre-procedure timeout) to VR engagement, before needle insertion | Time in minutes from VR headset placement to participant engagement with the VR environment, recorded by stopwatch on the workflow timing log by the research coordinator. Assessed in the VR + standard of care arm only. |
| Primary | Virtual Reality Discontinuation Rate | Day 1, from headset placement through needle withdrawal | Proportion of VR + standard of care participants requiring headset removal before needle withdrawal and dressing application, with documented reason (participant request, observed distress or adverse reaction, or treating physician determination that the headset interferes with the procedure). Pre-specified feasibility benchmark: discontinuation rate below 10%. |
| Primary | Total Procedure Duration | Day 1, from signing of procedure consent to dressing application | Time in minutes from signing of the clinical consent for the knee injection to needle withdrawal and dressing application, recorded by stopwatch on the workflow timing log. Durations will be compared between arms to estimate time added by VR. Pre-specified feasibility benchmark: VR adds 5 minutes or less to total procedure duration. |
| Primary | Patient Satisfaction With the Procedure | Day 1, immediately following the procedure | Participant-rated overall satisfaction with the knee injection procedure on a 0-10 Numerical Rating Scale (0 = not satisfied, 10 = completely satisfied). Higher scores indicate greater satisfaction. Reported by arm. |
| Primary | Provider-Reported Workflow Disruption | Day 1, immediately following the procedure | Proportion of procedures in which the treating provider reports that the VR headset required modification to standard procedure steps (yes/no), with optional free-text description. |
| Primary | Provider-Reported Patient Comfort | Day 1, immediately following the procedure | Treating provider's rating of how comfortable the patient appeared during the procedure on a 0-10 Numerical Rating Scale (0 = not comfortable at all, 10 = extremely comfortable). Higher scores indicate greater perceived comfort. Reported by arm. |
| Primary | Willingness to Use Virtual Reality Again | Day 1, immediately following the procedure | Proportion of VR + standard of care participants answering "yes" to whether they would enjoy using VR in this procedure again. Pre-specified feasibility benchmark: 60% or greater. |
| Secondary | Procedural Pain Ratings | Day 1, immediately following the procedure | Three participant-rated items on 0-10 Numerical Rating Scales, each reported separately: (1) worst pain during the injection (0 = no pain at all, 10 = excruciating pain); (2) pain unpleasantness during the injection (0 = not unpleasant at all, 10 = excruciatingly unpleasant); (3) time spent thinking about pain during the injection (0 = none of the time, 10 = all of the time). Higher scores indicate worse outcomes on all three items. Reported by arm. |
| Secondary | Anxiety During the Procedure, Adjusted for Baseline | Baseline (Day 1, after consent and before randomization) and Day 1 immediately following the procedure | Participant-rated anxiety on a 0-10 Numerical Rating Scale (0 = not anxious or nervous at all, 10 = extremely anxious/nervous), measured at baseline (feeling prior to the injection) and post-procedure (feeling during the injection). Higher scores indicate greater anxiety. Procedural anxiety will be compared between arms with adjustment for baseline anxiety. |
| Secondary | Change in Cybersickness Symptoms From Baseline | Baseline (Day 1, before randomization) and Day 1 immediately following the procedure | Four participant-rated symptoms on 0-10 Numerical Rating Scales, each reported separately: nausea (0 = no nausea at all, 10 = vomit), dizziness/spinning sensations (0 = no dizziness at all, 10 = extreme dizziness), headache (0 = no headache at all, 10 = extreme headache), and eye strain (0 = no eye strain at all, 10 = extreme eye strain). Each is rated at baseline and post-procedure. Higher scores indicate worse symptoms. Change for each symptom is calculated as post-procedure minus baseline. Reported by arm. |
| Secondary | Perceived Procedure Experience | Day 1, immediately following the procedure | Three participant-rated items on 0-10 Numerical Rating Scales, each reported separately: (1) enjoyment during the injection (0 = no fun at all, 10 = extremely fun); (2) perceived speed of the procedure (0 = very slow, 5 = standard, 10 = very fast); (3) vividness of memory of the procedure (0 = no memory, 10 = indistinguishable or extremely vivid). Higher scores indicate more enjoyment, faster perceived speed, and more vivid memory, respectively. Reported by arm. |
| Secondary | Perceived Distraction by the Virtual Environment | Day 1, immediately following the procedure | Participant rating of how distracted they felt from the knee injection by the virtual world on a 0-10 Numerical Rating Scale (0 = not distracted at all, 10 = extremely distracted). Higher scores indicate greater distraction. VR + standard of care arm only. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07884851/registered