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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
ClinicalTrials.gov, NCT03591822

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