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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01575912
Other study ID # 2012-A00047-36
Secondary ID
Status Completed
Phase N/A
First received March 13, 2012
Last updated June 9, 2017
Start date March 2012
Est. completion date January 2014

Study information

Verified date June 2017
Source Centre Hospitalier Esquirol
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Other:
experimental pain tests


Locations

Country Name City State
France Centre Hospitalier Esquirol Limoges

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Esquirol

Country where clinical trial is conducted

France, 

References & Publications (1)

Girard M, Plansont B, Bonnabau H, Malauzat D. Experimental pain hypersensitivity in schizophrenic patients. Clin J Pain. 2011 Nov-Dec;27(9):790-5. doi: 10.1097/AJP.0b013e31821d904c. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale Evaluation for the Pre-fixed Pressure Test 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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