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Pilot Study of a Robot-assisted Intervention for the Management of Care-induced Pain in Dementia

NCT03591822 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-09-12

No results posted yet for this study

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

Conditions

  • Moderate to Severe Dementia

Interventions

BEHAVIORAL

A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot

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.

BEHAVIORAL

B : Systemic evaluation of the pain

A systematic evaluation of the pain

Sponsors & Collaborators

  • The Paul Bennetot Foundation

    collaborator OTHER

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Anne-Sophie RIGAUD, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2019-04-12
Completion
2019-04-12

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03591822 on ClinicalTrials.gov