- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03994159
Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit (PARO)
Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit Specialized in Dementia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christelle Jadeau, PD
- Phone Number: 37 482 0 (33) 2 43 43 43 43
- Email: cjadeau@ch-lemans.fr
Study Locations
-
-
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Beaumont sur Sarthe, France, 72170
- Recruiting
- Centre Hospitalier Local Beaumont sur Sarthe
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Contact:
- Cathy LOIRAT
- Phone Number: 0243434343
- Email: cloirat@ch-lemans.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: PARO emotional robot
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. |
PARO is an advanced interactive therapeutic robot designed to stimulate patients with Dementia, Alzheimer's, and other cognition disorders.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of the PARO robot on the quality of worklife among caregivers in a specialised unit dor dementia patients
Time Frame: 1 month
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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.
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1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of PARO on the caregivers perception of their own health.
Time Frame: 1 month
|
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.
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1 month
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Impact of PARO on the caregivers perception of their own stress at work.
Time Frame: 1 month
|
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.
|
1 month
|
Impact of PARO on the caregivers perception of their own anxiety at work.
Time Frame: 1 month
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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).
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1 month
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cathy LOIRAT, Centre Hospitalier Du Mans
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHM-2019/S18/06.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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