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

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ClinicalTrials.gov Identifier: NCT03591822
Recruitment Status : Not yet recruiting
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborator:
The Paul Bennetot Foundation
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment Phase
Moderate to Severe Dementia Behavioral: A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot Behavioral: B : Systemic evaluation of the pain Not Applicable

Detailed Description:

in is a frequent problem in persons with moderate to severe dementia and has been associated to different care situations. Daily observations in care homes show that pain frequently causes anxiety and behavioral symptoms, including agitation and opposition to nursing care. A key recommendation of the International Psychogeriatric Association (IPA) is the use of psychosocial approaches as first-line therapy for behavioral problems in persons with dementia. Indeed, a wide range of non-pharmacological interventions for persons with dementia exist, such as biofeedback, music therapy, therapeutic touch or relaxation. Most of these interventions have shown positive results on health status, quality of life, socialization, and functional capacity in dementia. However, to date, little is known on the effect of psychosocial interventions on care-induced pain in this population. In consequence, there is still a need for the development of innovative interventions.

At a time when modern technologies are assuming a central role in our society, investigators are currently witnessing an important evolution of the use of social robots in healthcare interventions. In this research area, numerous studies have been conducted with social robots, such as PARO®, an animal-like robot modeled on a baby harp seal. Most of them have been successful in encouraging communication and/or social behaviors and also reducing Behavioral and Psychological Symptoms of Dementia (BPSD), loneliness, stress' levels, agitation and the use of pain medication. However, although these results indicate a potential application of robot-assisted therapies for pain management in persons with dementia, the use of PARO during painful care-situations is still to be investigated.

The investigators propose a new combination of current health cares, namely to mediate care-induced pain with the PARO robot.

Consequently, a randomized AB/BA crossover design will be employed. Patients will be assigned randomly to either phase A during which they will benefit from a systemic pain assessment and from the PARO robot as a therapeutic mediator, followed by phase B during which patients will benefit from a systemic pain assessment without the PARO robot, or phase B followed by phase A.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Prevention of Care-induced Pain in Elderly Persons With Cognitive Impairments and Living in EHPAD : Systematic Evaluation and Mediation With the PARO Robot.
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Arm AB : Intervention under study x Control intervention
Subjects 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.
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

Arm BA: Control intervention x Intervention under study
Subjects 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.
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




Primary Outcome Measures :
  1. ALGOPLUS scale [ Time Frame: 2 months ]

    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



Secondary Outcome Measures :
  1. PACSLAC-F score [ Time Frame: at inclusion ]
    A distal measure of pain .

  2. PACSLAC-F score [ Time Frame: 4 weeks ]
    A distal measure of pain .

  3. PACSLAC-F score [ Time Frame: 8 weeks ]
    A distal measure of pain .

  4. Simple verbal scale (SVS) [ Time Frame: 2 months ]
    Measurement with a scale in 3 points

  5. The appreciation of the Paro robot [ Time Frame: 2 months ]
    Measurement with a visual scale in 5 points: from 1 (not at all) to 5 (considerably) on a visual scale.

  6. Incidence of patient Medication [ Time Frame: 2 months ]
    Medications (analgesic, neuroleptic, anxiolytic, antidepressant, sleeping pill) taken by the patient

  7. EQ-5D score [ Time Frame: at inclusion ]
    A questionnaire (EQ-5D) of quality life which includes five single-item dimensions assessing: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression of participants.

  8. EQ-5D score [ Time Frame: 4 weeks ]
    A questionnaire (EQ-5D) of quality life which includes five single-item dimensions assessing: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression of participants.

  9. EQ-5D score [ Time Frame: 8 weeks ]
    A questionnaire (EQ-5D) of quality life which includes five single-item dimensions assessing: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression of participants.

  10. Appreciation of care [ Time Frame: 2 months ]
    Measurement with 2 visual scales in 4 and 5 points

  11. Appreciation of PARO robot [ Time Frame: 2 months ]
    Measurement with a visual scale in 5 points

  12. Duration of the care [ Time Frame: 2 months ]
  13. NASA-TLX score [ Time Frame: 2 months ]
    The NASA-TLX is an instrument to assess overall subjective workload with 6 dimensions of "workload" experienced by the health-care team: Mental Demand, Physical Demand and Temporal Demand, Frustration, Effort, and Performance



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591822


Contacts
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Contact: Anne-Sophie RIGAUD, MD, PhD + 33 1 44 08 35 03 anne-sophie.rigaud@aphp.fr
Contact: Marie GODARD +33 1 45 65 77 28 marie.godard@aphp.fr

Locations
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France
Résidence Mutualiste " L'adret "
Bellegarde En Forez, France, 42210
Contact: Christèle DECOT    + 33 4 77 54 47 18    cdecot@mutualite-loire.com   
Résidence Mutualiste " Les Tilleuls "
La Grand Croix, France, 43320
Contact: Marie-Christine DIANA, MD    + 33 4 77 73 26 93    mcdiana@mutualite-loire.com   
Hôpital Broca
Paris, France, 75013
Contact: Anne-Sophie RIGAUD, MD, PhD    + 33 1 44 08 35 03      
Résidence Mutualiste " La Cerisaie "
Saint Etienne, France, 42000
Contact: Philippe TERRAT, MD    + 33 4 77 74 28 44    pterrat@mutualite-loire.com   
Résidence Mutualiste " Marie Lagrevol "
Saint-just-malmont, France, 43240
Contact: Maryline MOUNIER    + 33 4 77 35 61 61    mmounier@mutualite-loire.com   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
The Paul Bennetot Foundation
Investigators
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Principal Investigator: Anne-Sophie RIGAUD, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03591822    
Other Study ID Numbers: K170608J
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Dementia
Pain
Nursing care
Psychosocial intervention
Robot-assisted therapy
paro robot
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders