Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994159
Recruitment Status : Not yet recruiting
First Posted : June 21, 2019
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Centre Hospitalier de Chateau du Loir
Centre Hospitalier de Saint Calais
Centre Hopsitalier Local de Beaumont sur Sarthe
Information provided by (Responsible Party):
Centre Hospitalier le Mans

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.


Condition or disease Intervention/treatment Phase
Burnout, Professional Stress Anxiety Device: Use of the "PARO" emotional robot Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Quasi experimental before-after study, with a mixed qualitative and quantitative approach.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit Specialized in Dementia
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

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.

Device: Use of the "PARO" emotional robot
PARO is an advanced interactive therapeutic robot designed to stimulate patients with Dementia, Alzheimer's, and other cognition disorders.




Primary Outcome Measures :
  1. Impact of the PARO robot on the quality of worklife among caregivers in a specialised unit dor dementia patients [ Time Frame: 1 month ]
    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 :
  1. 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.

  2. 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.

  3. Impact of PARO on the caregivers perception of their own anxiety at work. [ Time Frame: 1 month ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994159


Contacts
Layout table for location contacts
Contact: Christelle Jadeau, PD 0 (33) 2 43 43 43 43 ext 37 482 cjadeau@ch-lemans.fr

Sponsors and Collaborators
Centre Hospitalier le Mans
Centre Hospitalier de Chateau du Loir
Centre Hospitalier de Saint Calais
Centre Hopsitalier Local de Beaumont sur Sarthe
Layout table for additonal information
Responsible Party: Centre Hospitalier le Mans
ClinicalTrials.gov Identifier: NCT03994159    
Other Study ID Numbers: CHM-2019/S18/06.
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Burnout, Professional
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases