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Behavior During Experimentally Induced Pain

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ClinicalTrials.gov Identifier: NCT01594528
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dominique Malauzat, Centre Hospitalier Esquirol

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel 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

Arms and Interventions
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Arm Intervention/treatment
Experimental: SC
behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with schizophrenia
 Other: pain tests
pain induction with pressure application or ischemia on the arm
Experimental: controls
behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects without any psychiatric trouble
 Other: pain tests
pain induction with pressure application or ischemia on the arm
Experimental: MD
behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with major depression
 Other: pain tests
pain induction with pressure application or ischemia on the arm


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


Eligibility Criteria
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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
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01594528


Locations
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France
Centre Hospitalier Esquirol
Limoges, France, 87025
Sponsors and Collaborators
Centre Hospitalier Esquirol
Investigators
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Principal Investigator: Dominique Malauzat, MD Centre Hospitalier Esquirol
More Information
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Responsible Party: Dominique Malauzat, MD, Head of Research Department, Centre Hospitalier Esquirol
ClinicalTrials.gov Identifier: NCT01594528    
Other Study ID Numbers: 2012-A00048-35
First Posted: May 9, 2012    Key Record Dates
Results First Posted: March 22, 2019
Last Update Posted: March 22, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dominique Malauzat, Centre Hospitalier Esquirol:
schizophrenia
major depression
pain
behavior
Additional relevant MeSH terms:
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Depression
Schizophrenia
Depressive Disorder, Major
Behavioral Symptoms
 Depressive Disorder
Mood Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders