NCT03994159

Brief Summary

Since February 2016, with the objective of improving the quality of life and the autonomy of residents, the Le Mans General Hospital uses an interactive "emotional" robot within its geriatric wards. This emotional robot, Paro, is equipped with a dozen sensors, 3 microphones and interacts with its user: it reacts to touch, voice and heat making small sounds and moves its head, fins and tail. The algorithm that governs Paro's behavior allows him to offer a behavioral answer adapted to the user's stimuli. Thus, Paro is able to communicate beneficial emotions to patients. To this day however there is no published study exploring the effect of such a robot on team dynamics among caregivers in hospital units. Our research aims at highlighting the benefits that a healthcare team perceives when working with this tool among patients suffering from dementia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 21, 2019

Completed
2.7 years until next milestone

Study Start

First participant enrolled

March 14, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

April 1, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

June 6, 2019

Last Update Submit

March 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Impact of the PARO robot on the quality of worklife among caregivers in a specialised unit dor dementia patients

    Semidirective interviews of the caregivers about their feelings at work, before the introduction of Paro and after 1 month of use. We will use textual analysis software to reveal speech classes to avoid analysis bias and interpretation.

    1 month

Secondary Outcomes (3)

  • Impact of PARO on the caregivers perception of their own health.

    1 month

  • Impact of PARO on the caregivers perception of their own stress at work.

    1 month

  • Impact of PARO on the caregivers perception of their own anxiety at work.

    1 month

Study Arms (1)

PARO emotional robot

EXPERIMENTAL

Quasi-experimental before after study of the impact of the PARO robot on team dynamics among caregivers in geriatric wards caring for patients with dementia. Pre intervention period: no PARO robot. Post-intervention period: with the PARO robot.

Device: Use of the "PARO" emotional robot

Interventions

PARO is an advanced interactive therapeutic robot designed to stimulate patients with Dementia, Alzheimer's, and other cognition disorders.

PARO emotional robot

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non medical caregiver (nurse, nursing aid, orderly, psychological aid worker) working in one of the selected geriatric wards.

You may not qualify if:

  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Local Beaumont sur Sarthe

Beaumont-sur-Sarthe, 72170, France

RECRUITING

MeSH Terms

Conditions

Burnout, ProfessionalAnxiety Disorders

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Cathy LOIRAT

    Centre Hospitalier du Mans

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christelle Jadeau, PD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Quasi experimental before-after study, with a mixed qualitative and quantitative approach.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2019

First Posted

June 21, 2019

Study Start

March 14, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

April 1, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations