Pilot Study of a Robot-assisted Intervention for the Management of Care-induced Pain in Dementia
PARODOL
Prevention of Care-induced Pain in Elderly Persons With Cognitive Impairments and Living in EHPAD : Systematic Evaluation and Mediation With the PARO Robot.
1 other identifier
interventional
10
1 country
5
Brief 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 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 :
- 1.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.
- 2.examine socio-demographic and clinical responders' participants to the intervention, and,
- 3.identify essential elements regarding cost-effectiveness of a systematic evaluation of pain and a mediation with the PARO robot in care-induced pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2018
CompletedFirst Posted
Study publicly available on registry
July 19, 2018
CompletedStudy Start
First participant enrolled
February 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 12, 2019
CompletedSeptember 12, 2025
September 1, 2025
2 months
July 9, 2018
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
2 months
Secondary Outcomes (13)
PACSLAC-F score
at inclusion
PACSLAC-F score
4 weeks
PACSLAC-F score
8 weeks
Simple verbal scale (SVS)
2 months
The appreciation of the Paro robot
2 months
- +8 more secondary outcomes
Study Arms (2)
Arm AB : Intervention under study x Control intervention
OTHERSubjects 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
OTHERSubjects 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.
Interventions
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.
A systematic evaluation of the pain
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- The Paul Bennetot Foundationcollaborator
- URC-CIC Paris Descartes Necker Cochincollaborator
Study Sites (5)
Résidence Mutualiste " L'adret "
Bellegarde-en-Forez, 42210, France
Résidence Mutualiste " Les Tilleuls "
La Grand-Croix, 43320, France
Hôpital Broca
Paris, 75013, France
Résidence Mutualiste " La Cerisaie "
Saint-Etienne, 42000, France
Résidence Mutualiste " Marie Lagrevol "
Saint-Just-Malmont, 43240, France
Related Publications (1)
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.
PMID: 31289446BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne-Sophie RIGAUD, MD, PhD
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2018
First Posted
July 19, 2018
Study Start
February 15, 2019
Primary Completion
April 12, 2019
Study Completion
April 12, 2019
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share