Finished
Pilot Study of a Robot-assisted Intervention for the Management of Care-induced Pain in Dementia
NCT03591822 · Assistance Publique - Hôpitaux de Paris · Updated 12 Sept 2025
- What is being tested
- A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot; B : Systemic evaluation of the pain
- For
- Moderate to Severe Dementia
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 60 years and older. About 10 people. The full rules are on the registry page.
- Where
- France (5 sites)
- When
- Starts or started 15 Feb 2019, ends 12 April 2019. Registered 19 July 2018.
- Results
- None posted yet.
In the researchers' words
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
Sites
- Résidence Mutualiste " L'adret "Bellegarde-en-Forez, France
- Résidence Mutualiste " Les Tilleuls "La Grand-Croix, France
- Hôpital BrocaParis, France
- Résidence Mutualiste " La Cerisaie "Saint-Etienne, France
- Résidence Mutualiste " Marie Lagrevol "Saint-Just-Malmont, France
