Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| A Treatment Group That Will Watch a Non-VR Video Via an iPad | A treatment group that will watch a non-VR video via an iPad: The iPad is a tablet computer first offered by Apple in 2010.The device resembles a much larger version of Apple's iPhone or its iPod Touch, and is about the same size as a magazine. The iPad uses the same operating system as the Apple iPhone, and uses very similar hardware. iPad will be used to deliver non VR video to patients. A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups. | 0 | None | 0 | 76 | 0 | 76 | View |
| A Treatment Group That Will Have Headset on and Will Watch a VR Video | A treatment group that will have headset on and will watch a VR video: Oculus headset will deliver VR video to patients. Headset will be administered before intervention and removed at the completion of the intervention unless patient requests otherwise. Patients visual field will not change with head motion and will remain static throughout cast removal or pin/suture removal. A standardized age appropriate video will be used for patients between ages 4-14. The selected videos will be the same for both the cast and suture/pin removal groups. | 0 | None | 0 | 80 | 0 | 80 | View |
| A Treatment Group That Will be Immersed in the VR Game (Bear Blast) Via the Headset. | A treatment group that will be immersed in the VR game (Bear Blast) via the headset.: VR using the Oculus headset will deliver VR images and sound. Patients will watch a 15-minute VR experience called Bear Blast. Bear Blast is an immersive, 360-degree, game experience that takes place in a fantasy world where the user attempts to shoot balls at a wide range of moving objects by gently maneuvering his or her head toward the targets. Bear Blast is a nonviolent and noncompetitive game that incorporates motivational music and features positively reinforcing sounds, animation, and direct messages to patients. Bear Blast will be used as the standardized game for all patients in the VR group of both study arms. The VR Oculus headset can be controlled entirely via head motion and does not involve the use of patients extremities. | 0 | None | 0 | 70 | 0 | 70 | View |