CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
PARO Robotic Seal Intervention +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05565703
NCT05565703N/ACompleted

The Use of PARO to Decrease Agitation and Restlessness in Persons With Dementia and or Delirium

University of Pennsylvania·interventional·Posted Oct 4, 2022·Updated Jun 10, 2024

In Brief

A clinical study evaluating PARO Robotic Seal Intervention and Attention Control for Dementia and Delirium. Completed, enrolled 104 participants across 1 site.

Detailed Summary

This Clinical trial tests the efficacy of using the PARO robotic seal to decrease agitation in hospitalized older adults with dementia and/or delirium. This clinical trial also tests the efficacy of the cleaning protocol for the robot. This randomized control trial includes a one hour interaction with the PARO robot two days in a row compared to an attention control with the researcher sitting with the participant in their room for one hour two days in a row. The outcomes being evaluated include both qualitative and quantitative data. Qualitative data from videotaped interactions with the persons interacting with the PARO Robot include episodes of agitation, and emotional responses to the robot via facial expressions. The quantitative outcomes include the Agitation, use of 1:1 sitters, use of psychoactive medications and length of stay.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDementia, Delirium
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 4, 2022
Enrollment StartOct 30, 2018
Primary CompletionOct 30, 2023
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 3.7 years ago

Interventions

PARO Robotic Seal Interventionother

PARO is a therapeutic robot used to comfort PWD exhibiting agitation and restlessness (www.parorobots.com). Participants are brought out to the activity are on the ACE Unit and provided with an isolation gown to wear during their interaction with the seal. The robot is then placed on their laps for them to hold on their laps, pet, rock and pick up. The participants can also brush the robot and/or give it a bath with baby wipes. The researcher encourages participant engagement with the robot. If the participant does not want the robot on their lap it is placed on a bedside table for them to interact with.

Attention Controlother

The participants are randomly assigned and receive a one hour visit by the researcher or research assistant