Clinical trial NCT02720731: Care-related Pain and Discomfort in People With Motor Disorder
Official title: Care-related Pain and Discomfort in Children and Adults With Motor Disorder in Medical Establishments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Motor Disorders
Pain
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Fondation de France
name: Fondation Motrice
name: Fondation Apicil
First posted: 2016-03-28
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children and adults with motor disorders admitted in medical institutions

Brief summary: The combination of motor disabilities, chronic pain, cognitive disabilities limiting the possibilities of communications and repeated potentially painful rehabilitation, exposes patients with motor disabilities to a high risk of induced pain in the specialized establishments. Induced pain is difficult to detect and is therefore little assessed and treated. Currently, little is known about the prevalence and conditions of occurrence of such induced pain as the clinical characteristics of patients (children, adults, severity of disability), the types of care and the nature of the institutional admission (medical or medico-social). Secondary objectives are to identify risk factors related to the induced pain and patient characteristics, as well as to create an easy-to-use weekly continuous pain assessment tool in a routine clinical set-up.

All daily life procedures or treatment carried out in children and adults with motor disability are collected for 5 days and 1 night. Collected data are clinical and demographic characteristics of patients, the intensity of the pain assessed by the care professional (FLACC-r) or the patient himself (VAS).

Clinically, the uncomfortable and painful procedures and risk factors for pain identified by this study will help the development of targeted preventive measures within institutions. Meanwhile, the study should sensitize Breton teams involved with regards to the induced pain, leading them to observe the behavior of patients, to admit any pain related to an act of daily life, and to ask for the medical profession to anticipate the painful experience.


Eligibility criteria: Inclusion Criteria:

* motor disorder
* institutionalized

Exclusion Criteria:

* chronical pain

Primary outcomes:
measure: Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale
timeFrame: 5 days
Secondary outcomes:
measure: Pain related to care-activities assessed with the Visual Analog Scale (VAS).
timeFrame: 5 days
Other outcomes:
Locations:
city: Dirinon
country: France
facility: Centre Creac'h Ar Roual
city: Guipavas
country: France
facility: IME section polyhandicapes Kerlaouen
city: Plabennec
country: France
facility: SEAPH-IME Kerveguen
city: Plerin cedex
country: France
facility: IEM Plerin
city: Ploemeur
country: France
facility: IEM Ar Men
city: Ploemeur
country: France
facility: Centre de Rééducation fonctionnelle de Kerpape
city: Rennes
country: France
facility: CHRU de Rennes
city: Roscoff Cedex
country: France
facility: Fondation Ildys site de Perhardy
city: Trevou Treguignec
country: France
facility: Centre Rééducation Trestel
city: Trevou Treguignec
country: France
facility: EEAP Maison de L'estran
Study officials:
affiliation: Univesrity Hospital of Brest
name: sylvain BROCHARD
role: STUDY_DIRECTOR
References: