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Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit (PARO)

Primary Purpose

Burnout, Professional, Stress, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of the "PARO" emotional robot
Sponsored by
Centre Hospitalier le Mans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Burnout, Professional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to participate in the study

Sites / Locations

  • Centre Hospitalier Local Beaumont sur SartheRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PARO emotional robot

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Impact of PARO on the caregivers perception of their own health.
Use of the Nottingham Health Profile (NHP). The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.
Impact of PARO on the caregivers perception of their own stress at work.
Measure of the level of stress using the Perceived Stress Scale: 10 item questionnaire, with responses ranging from 0 to 4 for each item, with a range from 0 to 40, 0 being no perceived stress ans 40 the maximum perceived stress.
Impact of PARO on the caregivers perception of their own anxiety at work.
Measure of the perceived anxiety through the Hospital Anxiety and Depression Scale (HADS, a 14 item questionnaire, each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression, 0 being no perceived anxiety and 21 the maximum perceived anxiety).

Full Information

First Posted
June 6, 2019
Last Updated
March 29, 2022
Sponsor
Centre Hospitalier le Mans
Collaborators
Centre Hospitalier de Chateau du Loir, Centre Hospitalier de Saint Calais, Centre Hospitalier Local de Beaumont sur Sarthe
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1. Study Identification

Unique Protocol Identification Number
NCT03994159
Brief Title
Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit
Acronym
PARO
Official Title
Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit Specialized in Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
March 1, 2023 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier le Mans
Collaborators
Centre Hospitalier de Chateau du Loir, Centre Hospitalier de Saint Calais, Centre Hospitalier Local de Beaumont sur Sarthe

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Professional, Stress, Anxiety

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Quasi experimental before-after study, with a mixed qualitative and quantitative approach.
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PARO emotional robot
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Use of the "PARO" emotional robot
Intervention Description
PARO is an advanced interactive therapeutic robot designed to stimulate patients with Dementia, Alzheimer's, and other cognition disorders.
Primary Outcome Measure Information:
Title
Impact of the PARO robot on the quality of worklife among caregivers in a specialised unit dor dementia patients
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Impact of PARO on the caregivers perception of their own health.
Description
Use of the Nottingham Health Profile (NHP). The NHP consists of two parts. The first part focuses on health and comprises 38 items which deal with pain, energy, sleep, mobility, emotional reaction and social isolation. The second part focuses on life areas affected and consists of 7 items which deal with problems regarding occupation, housework, social life, family life, sexual function, hobbies and holidays. All questions have only yes/no answer options and each section score is weighted. The higher the score, the greater the number and severity of problems. The highest score in any section is 100.
Time Frame
1 month
Title
Impact of PARO on the caregivers perception of their own stress at work.
Description
Measure of the level of stress using the Perceived Stress Scale: 10 item questionnaire, with responses ranging from 0 to 4 for each item, with a range from 0 to 40, 0 being no perceived stress ans 40 the maximum perceived stress.
Time Frame
1 month
Title
Impact of PARO on the caregivers perception of their own anxiety at work.
Description
Measure of the perceived anxiety through the Hospital Anxiety and Depression Scale (HADS, a 14 item questionnaire, each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression, 0 being no perceived anxiety and 21 the maximum perceived anxiety).
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non medical caregiver (nurse, nursing aid, orderly, psychological aid worker) working in one of the selected geriatric wards. Exclusion Criteria: Refusal to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christelle Jadeau, PD
Phone
0 (33) 2 43 43 43 43
Ext
37 482
Email
cjadeau@ch-lemans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cathy LOIRAT
Organizational Affiliation
Centre Hospitalier du Mans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Local Beaumont sur Sarthe
City
Beaumont sur Sarthe
ZIP/Postal Code
72170
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy LOIRAT
Phone
0243434343
Email
cloirat@ch-lemans.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit

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