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Behavior During Experimentally Induced Pain

This study is currently recruiting participants.
Verified May 2012 by Centre Hospitalier Esquirol
Sponsor:
Information provided by (Responsible Party):
Dominique Malauzat, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier:
NCT01594528
First received: March 13, 2012
Last updated: May 7, 2012
Last verified: May 2012
History of Changes
  Purpose

Numerous factors can influence the processing of pain message: the affective or emotional, the sensorial and the cognitive components. Interindividual variations at the emotional and cognitive levels may interfere with the pain message and the consecutive behavior. Some modifications in these components are observed in psychiatric troubles, but their influences on the behavior to pain have not been studied, although they have been studied in some populations characterized as non communicating, with obvious cognitive degradations (subject with dementia, older, newborns,…).In an other study in course, the past pain experience is explored in relation to results to experimental pain tests, emotional and anxious characteristics. This present pilot study aims at studying the infra-verbal behavioural signs during experimentally induced pain in subjects with schizophrenia, major depression, and controls.


Condition Intervention
Schizophrenia
Major Depression
 Other: pain tests

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Behavior During Experimentally Induced Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Esquirol:

Primary Outcome Measures:
  • Frequency of behavioral signs [ Time Frame: during pain tests (average 1 hour) ] [ Designated as safety issue: No ]
    number of corporal mobility, facial expression and sound indicators


Estimated Enrollment: 15
Study Start Date: April 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: diagnosis
diagnosis according to the DSM-IV-TR : major depression and schizophrenia, or control.
 Other: pain tests
pain induction with pressure application or ischemia on the arm

Detailed Description:

The objective is to search for behavioral non verbal indicators of pain during experimentally induced pain (pressure application, ischemia induction).

Included subjects are subjected to experimental pain tests : pressure application (160 kPa) with an algometer to determine the pain with Visual Analogic Scale (VAS), and ischemia induction to determine the time needed to feel pain with an intensity equivalent to 3 with the VAS.

Subjects are filmed during experimentation to identify the corporal mobility signs, facial expression signs and sonorous signs associated to pain stimulation.

Neurophysiological measures complete these observations : surface electromyogram, heart rate measure, blood pressure.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subjects with psychiatric trouble : diagnosis of schizophrenia or major depression according to the DSM-IV-TR criteria.
  • control subjects : without known psychiatric history.
  • age between 18 and 60.

Exclusion Criteria:

  • absence of consent, hospitalization under constraint, absence of health insurance.
  • inability to answer the questionnaires
  • pregnancy
  • antalgic or analgesic treatment
  • allergy to latex
  • non stabilized high blood pressure, bad blood coagulation,
  • peripheral neuropathy, nerve lesion, dermatosis at the superior extremities, muscular lesion or pathology at the upper member level
  • non treated alcohol dependence
  • illegal substance consumption in the past 48 hours
  • participation to an other biomedical study during the 2 weeks before inclusion, and until the pain tests, if this study can interfere with the realization of the objectives
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594528

Contacts
Contact: Dominique Malauzat, MD 0033555431100 drd@ch-esquirol-limoges.fr
Contact: Murielle Girard, PhD 0033555431028 murielle.girard@ch-esquirol-limoges.fr

Locations
France
Centre Hospitalier Esquirol Recruiting
Limoges, France, 87025
Contact: Dominique Malauzat, MD     0033555431100     drd@ch-esquirol-limoges.fr    
Contact: Murielle Girard, PhD     0033555431028     murielle.girard@ch-esquirol-limoges.fr    
Sponsors and Collaborators
Centre Hospitalier Esquirol
Investigators
Principal Investigator: Dominique Malauzat, MD Centre Hospitalier Esquirol
  More Information

No publications provided

Responsible Party: Dominique Malauzat, MD, Head of Research Department, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT01594528     History of Changes
Other Study ID Numbers: 2012-A00048-35
Study First Received: March 13, 2012
Last Updated: May 7, 2012
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Esquirol:
schizophrenia
major depression
pain
behavior

Additional relevant MeSH terms:
Depression
Depressive Disorder
Schizophrenia
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 23, 2013