Pilot Study of a Robot-assisted Intervention for the Management of Care-induced Pain in Dementia (NCT03591822) | Clinical Trial Compass
CompletedNot Applicable
Pilot Study of a Robot-assisted Intervention for the Management of Care-induced Pain in Dementia
France10 participantsStarted 2019-02-15
Plain-language 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
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.