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

NCT05565703 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-06-10

No results posted yet for this study

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.

Conditions

Interventions

OTHER

PARO Robotic Seal Intervention

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.

OTHER

Attention Control

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

Sponsors & Collaborators

Principal Investigators

  • Pamela Z Cacchione, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-30
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05565703 on ClinicalTrials.gov