Adverse Events Module

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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

Ignite Creation Date: 2025-12-25 @ 2:21 AM
Ignite Modification Date: 2025-12-26 @ 12:53 AM
NCT ID: NCT02995434
Description: The use of VR and 2D laptop computers have been established as clinically safe and are commonly used recreationally. VR users were screened for risk of epilepsy, seizures and motion sickness during recruitment as exclusion criteria to prevent participation of those at increased risk of those adverse events.
Frequency Threshold: 0
Time Frame: Adverse event data were collected during the entirety of the trial participation (up to 4 weeks) from the initial baseline recording of data to the end of the participants use of the multimedia/VR equipment. They were not recorded after participants ceased use of the equipment. Cybersickness self-reporting was undertaken every week during use of the equipment on a weekly basis. Participants were asked to report any events of sickness during the preceding week on a Friday.
Study: NCT02995434
Study Brief: Immersive Multimedia as an Adjunctive Measure for Pain Control in Cancer Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VR Group (Intervention Group) Participants were randomly assigned to the intervention group. The VR interventions are identical for each participant and consist of a PC running the immersive virtual reality application with a Virtual Reality headset that allows for 110 degrees field of view. The interventions are one month in length to enable customization to the therapy and record data over a long enough period of time to account for individual short-term changes in pain experience. Participants used the VR interventions every day with a time exposure of 30 minutes for four consecutive weeks. There was one rest day a week (normally a Sunday) where no therapy is given. The following VR experiences were used in the VR group: Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ Carpe Lucem: http://store.steampowered.com/app/433700/Carpe\_Lucem\_\_Seize\_The\_Light\_VR/ 0 None 0 50 35 50 View
2D Computer Group (Control Group) Participants were randomly assigned to the control group. The control group applications were identical for each participant. The control group was exposed to 2D PC equivalent versions of the same multimedia experiences but on their PC screen (without the Virtual Reality headset use). These are functionally similar to the VR experiences. Participants used the applications every day with a time exposure of 30 minutes for four consecutive weeks. There was one rest day a week (normally a Sunday) where no application is given. The following PC applications were used in the control group: Virtual Meditative Walk: http://painstudieslab.com/projects/virtual-meditative-walk/ Wildflowers: https://appadvice.com/app/wildflowers-mindfulness/988835763 Obduction: http://obduction.com/ The Witness: http://store.steampowered.com/app/210970/ 0 None 0 50 8 50 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Cybersickness NON_SYSTEMATIC_ASSESSMENT General disorders None View