Behavior During Experimentally Induced Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dominique Malauzat, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier:
NCT01594528
First received: March 13, 2012
Last updated: May 13, 2014
Last verified: May 2014

March 13, 2012
May 13, 2014
April 2012
December 2013   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01594528 on ClinicalTrials.gov Archive Site
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Not Provided
Not Provided
Not Provided
 
Behavior During Experimentally Induced Pain
Behavior During Experimentally Induced Pain

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Schizophrenia
  • Major Depression
Other: pain tests
pain induction with pressure application or ischemia on the arm
No Intervention: diagnosis
diagnosis according to the DSM-IV-TR : major depression and schizophrenia, or control.
Intervention: Other: pain tests
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01594528
2012-A00048-35
No
Dominique Malauzat, Centre Hospitalier Esquirol
Centre Hospitalier Esquirol
Not Provided
Principal Investigator: Dominique Malauzat, MD Centre Hospitalier Esquirol
Centre Hospitalier Esquirol
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP