Clinical trial NCT03591822: Pilot Study of a Robot-assisted Intervention for the Management of Care-induced Pain in Dementia
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Moderate to Severe Dementia
Keywords: Dementia
Pain
Nursing care
Psychosocial intervention
Robot-assisted therapy
paro robot
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: The Paul Bennetot Foundation
First posted: 2018-07-19
Enrollment: 10
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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.

Primary outcomes:
measure: ALGOPLUS scale
timeFrame: 2 months
Secondary outcomes:
measure: PACSLAC-F score
timeFrame: at inclusion
measure: PACSLAC-F score
timeFrame: 4 weeks
measure: PACSLAC-F score
timeFrame: 8 weeks
measure: Simple verbal scale (SVS)
timeFrame: 2 months
measure: The appreciation of the Paro robot
timeFrame: 2 months
measure: Incidence of patient Medication
timeFrame: 2 months
measure: EQ-5D score
timeFrame: at inclusion
measure: EQ-5D score
timeFrame: 4 weeks
measure: EQ-5D score
timeFrame: 8 weeks
measure: Appreciation of care
timeFrame: 2 months
measure: Appreciation of PARO robot
timeFrame: 2 months
measure: Duration of the care
timeFrame: 2 months
measure: NASA-TLX score
timeFrame: 2 months
Other outcomes:
Locations:
city: Bellegarde En Forez
country: France
facility: Résidence Mutualiste " L'adret "
city: La Grand Croix
country: France
facility: Résidence Mutualiste " Les Tilleuls "
city: Paris
country: France
facility: Hôpital Broca
city: Saint Etienne
country: France
facility: Résidence Mutualiste " La Cerisaie "
city: Saint-just-malmont
country: France
facility: Résidence Mutualiste " Marie Lagrevol "
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne-Sophie RIGAUD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: