Behavior During Experimentally Induced Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01594528
Recruitment Status : Completed
First Posted : May 9, 2012
Last Update Posted : May 14, 2014
Information provided by (Responsible Party):
Dominique Malauzat, Centre Hospitalier Esquirol

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Major Depression Other: pain tests Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Behavior During Experimentally Induced Pain
Study Start Date : April 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Frequency of behavioral signs [ Time Frame: during pain tests (average 1 hour) ]
    number of corporal mobility, facial expression and sound indicators

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01594528

Centre Hospitalier Esquirol
Limoges, France, 87025
Sponsors and Collaborators
Centre Hospitalier Esquirol
Principal Investigator: Dominique Malauzat, MD Centre Hospitalier Esquirol

Responsible Party: Dominique Malauzat, MD, Head of Research Department, Centre Hospitalier Esquirol Identifier: NCT01594528     History of Changes
Other Study ID Numbers: 2012-A00048-35
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Dominique Malauzat, Centre Hospitalier Esquirol:
major depression

Additional relevant MeSH terms:
Depressive Disorder, Major
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Depressive Disorder
Mood Disorders