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 |
|---|---|---|---|---|---|---|---|---|
| Mindfulness Training Group | Participants in the mindfulness training (MT) group will engage in a 60-min session of mindfulness program per week for 8 weeks. Mindfulness intervention: The mindfulness program called "Mindfulness-based peak performance (MBPP)" will be used in this study. MBPP is a program that consists of eight 60-min training, and a 60-min session weekly for 8-weeks. The MBPP program will include (1) 5 minutes of will start with a brief recap of the preceding session and homework discussion, (2) after which the 5 minutes of a brief story about performance aimed at inducing the learning motivation of the participants; (3) Followed by 20 minutes of a theoretical lecture introducing a new topic and then (4) 25 minutes of mindfulness exercise. (5) Finally, how to apply the mindfulness skills to sports context will be discussed at the end of each session for 5 minutes. | 0 | None | 0 | 26 | 0 | 26 | View |
| Waitlist Control Group | Participants in the waitlist control group will be required to maintain regular life and routine training. Once the participants in control group finished the whole experiment, they will be invited to participate in the MBPP program for eight weeks. | 0 | None | 0 | 27 | 0 | 27 | View |