Burnout, ProfessionalPARONCT03994159
Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit
A study testing Use of the "PARO" emotional robot in people with Burnout, Professional and Stress, run by Centre Hospitalier le Mans at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Stress, Anxiety
- What is being tested?
- Use of the "PARO" emotional robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2022to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non medical caregiver (nurse, nursing aid, orderly, psychological aid worker) working in one of the selected geriatric wards.
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Local Beaumont sur Sarthe
Beaumont-sur-Sarthe, 72170
Cathy LOIRAT, 0243434343, cloirat@ch-lemans.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Burnout, Professional, Stress, Anxiety
- Being tested
- Use of the "PARO" emotional robot
- Medical subject headings
- Burnout, Professional, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the "PARO" emotional robotDevice
PARO is an advanced interactive therapeutic robot designed to stimulate patients with Dementia, Alzheimer's, and other cognition disorders.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Use of the "PARO" emotional robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 1 month
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.
Measured: 1 month
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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start14 Mar 2022
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi experimental before-after study, with a mixed qualitative and quantitative approach.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Chateau du Loir, Centre Hospitalier de Saint Calais, Centre Hospitalier Local de Beaumont sur Sarthe
- Responsible party
- Sponsor
- Investigators
- Cathy LOIRAT, Principal investigator, Centre Hospitalier du Mans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994159
- Sponsor's protocol ID
- CHM-2019/S18/06.
- Acronym
- PARO
- Status last verified
- Mar 2022
- First submitted
- 6 Jun 2019
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Emotional Robot on Quality of Working Life of Caregivers in a Geriatric Unit Specialized in Dementia
- ClinicalTrials.gov ID
- NCT03994159
- Acronym / sponsor ID
- PARO / CHM-2019/S18/06.
- Conditions
- Burnout, Professional, Stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Chateau du Loir, Centre Hospitalier de Saint Calais, Centre Hospitalier Local de Beaumont sur Sarthe
- Study start
- 14 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi experimental before-after study, with a mixed qualitative and quantitative approach.
| Arm | Type | Receives |
|---|---|---|
| PARO emotional robot | Experimental | Device: Use of the "PARO" emotional robotQuasi-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non medical caregiver (nurse, nursing aid, orderly, psychological aid worker) working in one of the selected geriatric wards.
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the "PARO" emotional robotPARO is an advanced interactive therapeutic robot designed to stimulate patients with Dementia, Alzheimer's, and other cognition disorders. | Device | PARO emotional robot |
Primary outcome
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.
3 secondary outcomes
Impact of PARO on the caregivers perception of their own health.
Time frame: 1 month
Impact of PARO on the caregivers perception of their own stress at work.
Time frame: 1 month
Impact of PARO on the caregivers perception of their own anxiety at work.
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy LOIRAT principal investigator
Centre Hospitalier du Mans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the "PARO" emotional robot in people with Burnout, Professional and Stress, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christelle Jadeau, PD (0 (33) 2 43 43 43 43 ext. 37 482, cjadeau@ch-lemans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of the PARO robot on the quality of worklife among caregivers in a specialised unit dor dementia patients (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.