- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01575912
Past Pain Experience and Perception of Experimental Pain
Differences in pain perception between subjects with and without psychiatric illness may be influenced by the individual experience, and not primarily by the pathology, although the pathological frame may amplify it.The aim of this study is to establish if the characteristics of experimental pain feeling are influenced by the past pain experience, anxiety and emotion, independently from the diagnosis. The pain experience will be evaluated by an inventory of the potentially painful situations that one can come across through the life, to determine the following points : Number of painful events in the past, number of painful points during the last 6 months, number of painful events lasting more than 6 months, sum of pain intensities (graduated with Visual Analogic Scale VAS from 0 to 10), sum of gravity (evaluated from 0 to 5), the category of pain experience qualification (mostly affective, mostly sensorial, or both).
Schizophrenic, depressed and control participants will be recruited, and their pain experience throughout life will be put it in relation to experimental pain tests results (pressure application, ischemia induction), anxiety and emotion (Hospital Anxiety and Depression scale HAD), catastrophizing (Pain Catastrophizing Scale PCS), Heart Rate (HR) variation, Blood Pressure (BP) variation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The perception of moderated experimental pain (about 3 out of ten with visual analogue scale VAS) in subjects with schizophrenia (Girard et coll., 2011), major depression (ED) (bipolar or isolated/recurrent episode) (to be published) in comparison with controls without psychiatric pathologies show that exploration of pain in situation like medical examination to identify painful points should be done in the same conditions for persons with psychiatric troubles and persons without mental disease. But the risk is that the expression of pain, either in experimental conditions nor in the daily life, is not in relation with the feeling or perception of pain. Numerous factors may interfere in the pain message modulation, like the past pain experience, stress and anxiety, which are not or partially explored in experimental studies. The individual experience of pain is constructed throughout the whole life, from several influences (biological, psychological, and sociocultural). The symptoms interfaces of the different psychiatric troubles seem to be widely involved in the pain process, and its progressive construction. This study aims to better understand the relationships between all those variables.
Procedures applied :
Anterior pain experience evaluation (questionnaire); Pain tests : 160 kPa pressure application to determine corresponding pain with VAS), and ischemia induction to determine the time necessary to obtain a pain equivalent to 3 out of 10; anxiety and emotional evaluation (Hospital Anxiety and Depression scale), catastrophizing evaluation (Pain Catastrophizing Scale), HR variation and BP variation (vegetative measures linked to anxiety) collection of diagnosis, and therapeutic treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Limoges, France, 87025
- Centre Hospitalier Esquirol
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Subjects hospitalized in the Esquirol Hospital center with schizophrenia or major depression according to the DSM-IV-TR criteria.
Subjects without without known psychiatric history. Recruited persons will be matched according to age classes.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
schizophrenia SC
subjects with a diagnosis of schizophrenia (SC) according to the DSM-IV-TR, submitted to experimental pain tests
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major depression MD
subjects with a diagnosis of major depression (MD) according to the DSM-IV-TR, submitted to experimental pain tests
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controls C
subjects without any diagnosis of psychiatric disorder (C) submitted to experimental pain tests
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale Evaluation for the Pre-fixed Pressure Test
Time Frame: one month
|
pain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia. The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain. |
one month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dominique Malauzat, MD, Centre Hospitalier Esquirol
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2012-A00047-36
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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