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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03994159
Other study ID # CHM-2019/S18/06.
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 14, 2022
Est. completion date March 1, 2023

Study information

Verified date March 2022
Source Centre Hospitalier le Mans
Contact Christelle Jadeau, PD
Phone 0 (33) 2 43 43 43 43
Email cjadeau@ch-lemans.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 75
Est. completion date March 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France Centre Hospitalier Local Beaumont sur Sarthe Beaumont sur Sarthe

Sponsors (4)

Lead Sponsor Collaborator
Centre Hospitalier le Mans Centre Hospitalier de Chateau du Loir, Centre Hospitalier de Saint Calais, Centre Hospitalier Local de Beaumont sur Sarthe

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. 1 month
Secondary 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. 1 month
Secondary 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). 1 month
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