Care-related Pain and Discomfort in People With Motor Disorder (DIS-HANDI)

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Motor Disorders

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• France
  • Dirinon, France, 29460
    • Recruiting
    • Centre Creac'h Ar Roual
    • Contact: Françoise ROGE
  • Guipavas, France, 29490
    • Recruiting
    • IME section polyhandicapes Kerlaouen
    • Contact: Françoise ROGE
  • Plabennec, France, 29860
    • Not yet recruiting
    • SEAPH-IME Kerveguen
    • Contact: Sylvain Brochard
  • Plerin cedex, France, 22193
    • Not yet recruiting
    • IEM Plerin
    • Contact: Bruno Fagnet
  • Ploemeur, France, 56270
    • Not yet recruiting
    • IEM Ar Men
    • Contact: Mathilde Creusat
  • Ploemeur, France, 56275
    • Recruiting
    • Centre de rééducation fonctionnelle de KERPAPE
    • Contact: Hélène Le Tallec
  • Rennes, France, 35000
    • Not yet recruiting
    • CHRU de Rennes
    • Contact: Hélène Rauscent
  • Roscoff Cedex, France, 29684
    • Recruiting
    • Fondation Ildys site de Perhardy
    • Contact: Sylvaine Rumeur
  • Trevou Treguignec, France, 22660
    • Not yet recruiting
    • Centre Rééducation Trestel
    • Contact: Laurent Jesequel
  • Trevou Treguignec, France, 22660
    • Not yet recruiting
    • EEAP Maison de L'estran
    • Contact: Dr Darnois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

children and adults with motor disorders admitted in medical institutions

Description

Inclusion Criteria:

• motor disorder
• institutionalized

Exclusion Criteria:

• chronical pain

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
children; aged from 1 to 18 years with motor disorder
adults; aged from 18 to 80 years with motor disorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain related to care-activities assessed with the Face, Legs, Activity, Cry, Consolability (FLACC-r) scale	5 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Pain related to care-activities assessed with the Visual Analog Scale (VAS).	5 days

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Collaborators: Fondation Apicil; Fondation de France; Fondation Motrice
• Investigators: Study Director: sylvain BROCHARD, Univesrity Hospital of Brest

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): November 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 22, 2016
• First Posted (Estimate): March 28, 2016

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: July 11, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Motor Disorders
• Other Study ID Numbers: DIS-HANDI (RB 14.188)