Moderate to Severe DementiaPARODOLNCT03591822
Pilot Study of a Robot-assisted Intervention for the Management of Care-induced Pain in Dementia
A study testing A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot and B : Systemic evaluation of the pain in people with Moderate to Severe Dementia, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial summary
Health care professionals lack tools to deal with acute pain in patients with moderate to severe dementia during daily nursing situations. Care-induced pain in institutionalized persons with cognitive impairments can cause anxiety and behavioral problems.The aim of this study is to demonstrate that a systematic… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Moderate to Severe Dementia
- What is being tested?
- A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot and B : Systemic evaluation of the pain
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 5 sitesFrance
- Study dates
- 15 Feb 2019to 12 Apr 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient over 60 years of age
- Consent to participate
- Patient diagnosed by a geriatrician or a neurologist with moderate to severe dementia (MMSE<24), according to the criteria of the Diagnostic and Statistical Manual DSM IV-TR (APA,2004) and NINCDS-ADRDA(McKhann et al.1984).
- Patient living in a nursing home or a long stay department
- Painful patient during nursing care (pain drugs prescription or direct observation)
Who cannot join
- Patient (or patient's legal representative) does not provide consent
- The presence of acute organic disease or psychiatric decompensation and major neuropsychiatric symptoms incompatible with the intervention.
- Patient who cannot interact physically with Paro
- The presence of multidrug-resistant bacteria in patient to reduce the risk of contamination.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Résidence Mutualiste " L'adret "
Bellegarde-en-Forez, 42210
Résidence Mutualiste " Les Tilleuls "
La Grand-Croix, 43320
Hôpital Broca
Paris, 75013
Résidence Mutualiste " La Cerisaie "
Saint-Etienne, 42000
Résidence Mutualiste " Marie Lagrevol "
Saint-Just-Malmont, 43240
About this study
Official title: Prevention of Care-induced Pain in Elderly Persons With Cognitive Impairments and Living in EHPAD : Systematic Evaluation and Mediation With the PARO Robot.
Health care professionals lack tools to deal with acute pain in patients with moderate to severe dementia during daily nursing situations. Care-induced pain in institutionalized persons with cognitive impairments can cause anxiety and behavioral problems.The aim of this study is to demonstrate that a systematic identification of pain associated with the use of social robots such as the PARO robot may contribute to a better anticipation and management of care-induced pain. The investigators hypothesize that an individual use of the PARO robot would bring relaxation to the patient, a distraction regarding the aversive situation of care and, thus, it would prevent manifestations of acute pain in patients with dementia.
Secondary objectives of the study :
- determine the effect of the use of PARO during painful cares on quality of life, medication of patients, and perceived workload of the health-care team.
- examine socio-demographic and clinical responders' participants to the intervention, and,
- identify essential elements regarding cost-effectiveness of a systematic evaluation of pain and a mediation with the PARO robot in care-induced pain
Read the detailed description
in is a frequent problem in persons with moderate to severe dementia and has been associated to different care situations. Daily observations in care homes show that pain frequently causes anxiety and behavioral symptoms, including agitation and opposition to nursing care. A key recommendation of the International Psychogeriatric Association (IPA) is the use of psychosocial approaches as first-line therapy for behavioral problems in persons with dementia. Indeed, a wide range of non-pharmacological interventions for persons with dementia exist, such as biofeedback, music therapy, therapeutic touch or relaxation. Most of these interventions have shown positive results on health status, quality of life, socialization, and functional capacity in dementia. However, to date, little is known on the effect of psychosocial interventions on care-induced pain in this population. In consequence, there is still a need for the development of innovative interventions.
At a time when modern technologies are assuming a central role in our society, investigators are currently witnessing an important evolution of the use of social robots in healthcare interventions. In this research area, numerous studies have been conducted with social robots, such as PARO®, an animal-like robot modeled on a baby harp seal. Most of them have been successful in encouraging communication and/or social behaviors and also reducing Behavioral and Psychological Symptoms of Dementia (BPSD), loneliness, stress' levels, agitation and the use of pain medication. However, although these results indicate a potential application of robot-assisted therapies for pain management in persons with dementia, the use of PARO during painful care-situations is still to be investigated.
The investigators propose a new combination of current health cares, namely to mediate care-induced pain with the PARO robot.
Consequently, a randomized AB/BA crossover design will be employed. Patients will be assigned randomly to either phase A during which they will benefit from a systemic pain assessment and from the PARO robot as a therapeutic mediator, followed by phase B during which patients will benefit from a systemic pain assessment without the PARO robot, or phase B followed by phase A.
- Conditions
- Moderate to Severe Dementia
- Being tested
- A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot, B : Systemic evaluation of the pain
- Keywords
- Dementia, Pain, Nursing care, Psychosocial intervention, Robot-assisted therapy, paro robot
- Medical subject headings
- Dementia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A : Systemic evaluation of the pain and mediation with the PARO therapeutic robotBehavioural
Each session with the PARO robot will encompasses the same four following steps (a) Meeting Paro (b) Proposing contact (c) Individually using Paro during the care (d) End of the exposure.
B : Systemic evaluation of the painBehavioural
A systematic evaluation of the pain
| Study group | Role | What they receive |
|---|---|---|
| Arm AB : Intervention under study x Control intervention | Other | Subjects receive intervention A during which they will benefit from a systemic pain assessment and from the PARO robot as a therapeutic mediator, followed by intervention B during which patients will benefit from a systemic pain assessment without the PARO robot. Receives: Behavioral: A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot; Behavioral: B : Systemic evaluation of the pain |
| Arm BA: Control intervention x Intervention under study | Other | Subjects receive intervention B during which they will benefit from a systemic pain assessment without the PARO robot, followed by intervention A during which patients will benefit from a systemic pain assessment and from the PARO robot as a therapeutic mediator. Receives: Behavioral: A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot; Behavioral: B : Systemic evaluation of the pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALGOPLUS scale
A proximal measure of pain rating on a scale of 1) facial expressions, 2) look, 3) complaints, 4) body position and, 5) atypical behaviors.
And a distal measures of pain
Measured: 2 months
Secondary outcomes (13)
PACSLAC-F score
A distal measure of pain .
Measured: at inclusion
PACSLAC-F score
A distal measure of pain .
Measured: 4 weeks
PACSLAC-F score
A distal measure of pain .
Measured: 8 weeks
Simple verbal scale (SVS)
Measurement with a scale in 3 points
Measured: 2 months
The appreciation of the Paro robot
Measurement with a visual scale in 5 points: from 1 (not at all) to 5 (considerably) on a visual scale.
Measured: 2 months
Incidence of patient Medication
Medications (analgesic, neuroleptic, anxiolytic, antidepressant, sleeping pill) taken by the patient
Measured: 2 months
EQ-5D score
A questionnaire (EQ-5D) of quality life which includes five single-item dimensions assessing: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression of participants.
Measured: at inclusion
EQ-5D score
A questionnaire (EQ-5D) of quality life which includes five single-item dimensions assessing: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression of participants.
Measured: 4 weeks
EQ-5D score
A questionnaire (EQ-5D) of quality life which includes five single-item dimensions assessing: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression of participants.
Measured: 8 weeks
Appreciation of care
Measurement with 2 visual scales in 4 and 5 points
Measured: 2 months
Appreciation of PARO robot
Measurement with a visual scale in 5 points
Measured: 2 months
Duration of the care
Measured: 2 months
NASA-TLX score
The NASA-TLX is an instrument to assess overall subjective workload with 6 dimensions of "workload" experienced by the health-care team: Mental Demand, Physical Demand and Temporal Demand, Frustration, Effort, and Performance
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start15 Feb 2019
- Primary completion12 Apr 2019
- Study completion12 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to Severe DementiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- The Paul Bennetot Foundation, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Anne-Sophie RIGAUD, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591822
- Sponsor's protocol ID
- K170608J
- Acronym
- PARODOL
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2018
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Demange M, Pino M, Kerherve H, Rigaud AS, Cantegreil-Kallen I. Management of acute pain in dementia: a feasibility study of a robot-assisted intervention. J Pain Res. 2019 Jun 7;12:1833-1846. doi: 10.2147/JPR.S179640. eCollection 2019.
PubMed 31289446
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Care-induced Pain in Elderly Persons With Cognitive Impairments and Living in EHPAD : Systematic Evaluation and Mediation With the PARO Robot.
- ClinicalTrials.gov ID
- NCT03591822
- Acronym / sponsor ID
- PARODOL / K170608J
- Conditions
- Moderate to Severe Dementia
- Keywords
- Dementia, Pain, Nursing care, Psychosocial intervention, Robot-assisted therapy, paro robot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- The Paul Bennetot Foundation, URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 12 Apr 2019 (actual)
- First posted
- 19 Jul 2018 (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.
Health care professionals lack tools to deal with acute pain in patients with moderate to severe dementia during daily nursing situations. Care-induced pain in institutionalized persons with cognitive impairments can cause anxiety and behavioral problems.The aim of this study is to demonstrate that a systematic identification of pain associated with the use of social robots such as the PARO robot may contribute to a better anticipation and management of care-induced pain. The investigators hypothesize that an individual use of the PARO robot would bring relaxation to the patient, a distraction regarding the aversive situation of care and, thus, it would prevent manifestations of acute pain in patients with dementia.
Secondary objectives of the study :
- determine the effect of the use of PARO during painful cares on quality of life, medication of patients, and perceived workload of the health-care team.
- examine socio-demographic and clinical responders' participants to the intervention, and,
- identify essential elements regarding cost-effectiveness of a systematic evaluation of pain and a mediation with the PARO robot in care-induced pain
Detailed description
in is a frequent problem in persons with moderate to severe dementia and has been associated to different care situations. Daily observations in care homes show that pain frequently causes anxiety and behavioral symptoms, including agitation and opposition to nursing care. A key recommendation of the International Psychogeriatric Association (IPA) is the use of psychosocial approaches as first-line therapy for behavioral problems in persons with dementia. Indeed, a wide range of non-pharmacological interventions for persons with dementia exist, such as biofeedback, music therapy, therapeutic touch or relaxation. Most of these interventions have shown positive results on health status, quality of life, socialization, and functional capacity in dementia. However, to date, little is known on the effect of psychosocial interventions on care-induced pain in this population. In consequence, there is still a need for the development of innovative interventions.
At a time when modern technologies are assuming a central role in our society, investigators are currently witnessing an important evolution of the use of social robots in healthcare interventions. In this research area, numerous studies have been conducted with social robots, such as PARO®, an animal-like robot modeled on a baby harp seal. Most of them have been successful in encouraging communication and/or social behaviors and also reducing Behavioral and Psychological Symptoms of Dementia (BPSD), loneliness, stress' levels, agitation and the use of pain medication. However, although these results indicate a potential application of robot-assisted therapies for pain management in persons with dementia, the use of PARO during painful care-situations is still to be investigated.
The investigators propose a new combination of current health cares, namely to mediate care-induced pain with the PARO robot.
Consequently, a randomized AB/BA crossover design will be employed. Patients will be assigned randomly to either phase A during which they will benefit from a systemic pain assessment and from the PARO robot as a therapeutic mediator, followed by phase B during which patients will benefit from a systemic pain assessment without the PARO robot, or phase B followed by phase A.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm AB : Intervention under study x Control intervention | Other | Behavioral: A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot, Behavioral: B : Systemic evaluation of the painSubjects receive intervention A during which they will benefit from a systemic pain assessment and from the PARO robot as a therapeutic mediator, followed by intervention B during which patients will benefit from a systemic pain assessment without the PARO robot. |
| Arm BA: Control intervention x Intervention under study | Other | Behavioral: A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot, Behavioral: B : Systemic evaluation of the painSubjects receive intervention B during which they will benefit from a systemic pain assessment without the PARO robot, followed by intervention A during which patients will benefit from a systemic pain assessment and from the PARO robot as a therapeutic mediator. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient over 60 years of age
- Consent to participate
- Patient diagnosed by a geriatrician or a neurologist with moderate to severe dementia (MMSE<24), according to the criteria of the Diagnostic and Statistical Manual DSM IV-TR (APA,2004) and NINCDS-ADRDA(McKhann et al.1984).
- Patient living in a nursing home or a long stay department
- Painful patient during nursing care (pain drugs prescription or direct observation)
Key exclusion criteria (4 listed)
- Patient (or patient's legal representative) does not provide consent
- The presence of acute organic disease or psychiatric decompensation and major neuropsychiatric symptoms incompatible with the intervention.
- Patient who cannot interact physically with Paro
- The presence of multidrug-resistant bacteria in patient to reduce the risk of contamination.
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 |
|---|---|---|
| A : Systemic evaluation of the pain and mediation with the PARO therapeutic robotEach session with the PARO robot will encompasses the same four following steps (a) Meeting Paro (b) Proposing contact (c) Individually using Paro during the care (d) End of the exposure. | Behavioural | Arm AB : Intervention under study x Control intervention, Arm BA: Control intervention x Intervention under study |
| B : Systemic evaluation of the painA systematic evaluation of the pain | Behavioural | Arm AB : Intervention under study x Control intervention, Arm BA: Control intervention x Intervention under study |
Primary outcome
ALGOPLUS scale
Time frame: 2 months
A proximal measure of pain rating on a scale of 1) facial expressions, 2) look, 3) complaints, 4) body position and, 5) atypical behaviors. And a distal measures of pain
13 secondary outcomes
PACSLAC-F score
Time frame: at inclusion
PACSLAC-F score
Time frame: 4 weeks
PACSLAC-F score
Time frame: 8 weeks
Simple verbal scale (SVS)
Time frame: 2 months
The appreciation of the Paro robot
Time frame: 2 months
Incidence of patient Medication
Time frame: 2 months
EQ-5D score
Time frame: at inclusion
EQ-5D score
Time frame: 4 weeks
EQ-5D score
Time frame: 8 weeks
Appreciation of care
Time frame: 2 months
Appreciation of PARO robot
Time frame: 2 months
Duration of the care
Time frame: 2 months
NASA-TLX score
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 31289446Demange M, Pino M, Kerherve H, Rigaud AS, Cantegreil-Kallen I. Management of acute pain in dementia: a feasibility study of a robot-assisted intervention. J Pain Res. 2019 Jun 7;12:1833-1846. doi: 10.2147/JPR.S179640. eCollection 2019.
- 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.
Anne-Sophie RIGAUD, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot and B : Systemic evaluation of the pain in people with Moderate to Severe Dementia, run by Assistance Publique - Hôpitaux de Paris at 5 sites 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALGOPLUS scale (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03591822, which also lists 1 linked publication.
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 12 Sep 2025.