Care-related Pain and Discomfort in People With Motor Disorder

Pain Clinical Trial

— DIS-HANDI  

Official title:

Care-related Pain and Discomfort in Children and Adults With Motor Disorder in Medical Establishments

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02720731
• Other study ID #: DIS-HANDI (RB 14.188)
• 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

• Disease
• Motor Disorders
• Pain

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