Behavior During Experimentally Induced Pain
1 other identifier
interventional
49
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable schizophrenia
Started Apr 2012
Shorter than P25 for not_applicable schizophrenia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedResults Posted
Study results publicly available
March 22, 2019
CompletedMarch 22, 2019
December 1, 2018
1.7 years
March 13, 2012
January 31, 2017
December 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Indicators / Minute
number of corporal mobility, facial expression and sound indicators
during pain tests (average 1 hour)
Study Arms (3)
SC
EXPERIMENTALbehavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with schizophrenia
controls
EXPERIMENTALbehavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects without any psychiatric trouble
MD
EXPERIMENTALbehavior as defined with facial, corporal and vocal indicators during experimental pain tests for subjects with major depression
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Hospitalier Esquirol
Limoges, 87025, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Murielle Girard
- Organization
- Centre Hospitalier Esquirol
Study Officials
- PRINCIPAL INVESTIGATOR
Dominique Malauzat, MD
Centre Hospitalier Esquirol
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Head of Research Department
Study Record Dates
First Submitted
March 13, 2012
First Posted
May 9, 2012
Study Start
April 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
March 22, 2019
Results First Posted
March 22, 2019
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share