Back to results

Behavior During Experimentally Induced Pain

Primary Purpose

Schizophrenia, Major Depression

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

pain tests

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring schizophrenia, major depression, pain, behavior

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Centre Hospitalier Esquirol

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

controls

Arm Description

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with schizophrenia

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects without any psychiatric trouble

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with major depression

Outcomes

Primary Outcome Measures

Indicators / Minute

number of corporal mobility, facial expression and sound indicators

Secondary Outcome Measures

Full Information

NCT ID

NCT01594528

First Posted

March 13, 2012

Last Updated

December 17, 2018

Sponsor

Centre Hospitalier Esquirol

1. Study Identification

Unique Protocol Identification Number

NCT01594528

Brief Title

Behavior During Experimentally Induced Pain

Official Title

Behavior During Experimentally Induced Pain

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier Esquirol

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia, Major Depression

Keywords

schizophrenia, major depression, pain, behavior

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with schizophrenia

Arm Title

controls

Arm Type

Experimental

Arm Description

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects without any psychiatric trouble

Arm Title

Arm Type

Experimental

Arm Description

behavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with major depression

Intervention Type

Other

Intervention Name(s)

pain tests

Intervention Description

pain induction with pressure application or ischemia on the arm

Primary Outcome Measure Information:

Title

Indicators / Minute

Description

number of corporal mobility, facial expression and sound indicators

Time Frame

during pain tests (average 1 hour)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominique Malauzat, MD

Organizational Affiliation

Centre Hospitalier Esquirol

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre Hospitalier Esquirol

City

Limoges

ZIP/Postal Code

87025

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Behavior During Experimentally Induced Pain

We'll reach out to this number within 24 hrs