Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2025-12-25 @ 12:24 PM
NCT ID:
NCT05075395
Group ID:
EG000
Title:
Intervention
Description:
The PT/OT provider will assess whether the patient meets eligibility criteria. If the patient is eligible to participate, they will then introduce the study to the patient and their parent or guardian. If the patient is interested in participating, the PI or PIs research assistant (RA) will seek written informed consent. After informed consent is obtained, the PI or RA will begin pretest data collection. Then, the PT/OT provider will begin the therapy session with Paro. The PI or RA will remain in the room during therapy session to record field notes. When the therapy session is complete, the PI or RA will begin posttest data collection. The patient will remain in the study for up to 7 PT/OT sessions or until they are discharged from the PICU. The PT/OT providers will coordinate all subsequent therapy sessions with the PI/RA while the patient remains on the study protocol.
PARO therapy seal: PARO, a baby harp seal, is an advanced interactive, therapeutic medical robot developed by AIST, a leading Japanese industrial automation pioneer. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties.
Deaths Number Affected:
0
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
19
Other Number Affected:
0
Other Number At Risk:
19
Study:
NCT05075395
Results Section:
NCT05075395
Adverse Events Module:
NCT05075395