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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02720731
Other study ID # DIS-HANDI (RB 14.188)
Secondary ID
Status Recruiting
Phase N/A
First received March 10, 2016
Last updated July 11, 2016
Start date April 2016
Est. completion date November 2017

Study information

Verified date July 2016
Source University Hospital, Brest
Contact Sylvain BROCHARD
Phone 02-98-22-26-88
Email sylvain.brochard@chu-brest.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 80 Years
Eligibility Inclusion Criteria:

- motor disorder

- institutionalized

Exclusion Criteria:

- chronical pain

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Creac'h Ar Roual Dirinon
France IME section polyhandicapes Kerlaouen Guipavas
France SEAPH-IME Kerveguen Plabennec
France IEM Plerin Plerin cedex
France Centre de Rééducation fonctionnelle de Kerpape Ploemeur
France IEM Ar Men Ploemeur
France CHRU de Rennes Rennes
France Fondation Ildys site de Perhardy Roscoff Cedex
France Centre Rééducation Trestel Trevou Treguignec
France EEAP Maison de L'estran Trevou Treguignec

Sponsors (4)

Lead Sponsor Collaborator
University Hospital, Brest Fondation Apicil, Fondation de France, Fondation Motrice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale 5 days Yes
Secondary Pain related to care-activities assessed with the Visual Analog Scale (VAS). 5 days Yes
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