Behavior During Experimentally Induced Pain

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Major Depression
• Intervention / Treatment: Other: pain tests

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87025
    • Centre Hospitalier Esquirol

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Indicators / Minute	number of corporal mobility, facial expression and sound indicators	during pain tests (average 1 hour)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Esquirol
• Investigators: Principal Investigator: Dominique Malauzat, MD, Centre Hospitalier Esquirol

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: March 13, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 9, 2012

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: pain; schizophrenia; behavior; major depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder; Depression; Schizophrenia; Depressive Disorder, Major
• Other Study ID Numbers: 2012-A00048-35

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO