Behavior During Experimentally Induced Pain

Schizophrenia Clinical Trial

Official title:

Behavior During Experimentally Induced Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594528
• Other study ID #: 2012-A00048-35
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Esquirol
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• Major Depression
• Schizophrenia

Intervention

Other:
• pain tests
pain induction with pressure application or ischemia on the arm

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Indicators / Minute	number of corporal mobility, facial expression and sound indicators	during pain tests (average 1 hour)