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Behavior During Experimentally Induced Pain

Behavior During Experimentally Induced Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01594528
Enrollment
49
Registered
2012-05-09
Start date
2012-04-30
Completion date
2013-12-31
Last updated
2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depression, Schizophrenia

Keywords

schizophrenia, major depression, pain, behavior

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.

Interventions

OTHERpain tests

pain induction with pressure application or ischemia on the arm

Sponsors

Centre Hospitalier Esquirol
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Indicators / Minuteduring pain tests (average 1 hour)number of corporal mobility, facial expression and sound indicators

Countries

France

Participant flow

Participants by arm

ArmCount
Major Depression
subjects with major depression
16
Schizophrenia
subjects with schizophrenia
17
Control
subjects without psychiatric disorders
16
Total49

Baseline characteristics

CharacteristicMajor DepressionSchizophreniaControlTotal
Age, Continuous46 years42 years40 years41 years
Region of Enrollment
France
16 Participants17 Participants16 Participants49 Participants
Sex: Female, Male
Female
13 Participants3 Participants6 Participants22 Participants
Sex: Female, Male
Male
3 Participants14 Participants10 Participants27 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 49
other
Total, other adverse events
0 / 49
serious
Total, serious adverse events
0 / 49

Outcome results

Primary

Indicators / Minute

number of corporal mobility, facial expression and sound indicators

Time frame: during pain tests (average 1 hour)

ArmMeasureGroupValue (MEDIAN)
Group of Subjects Presenting Schizophrenia SCIndicators / Minutevocal indicators1.925 indicators/minute
Group of Subjects Presenting Schizophrenia SCIndicators / Minutefacial indicators0.25 indicators/minute
Group of Subjects Presenting Schizophrenia SCIndicators / Minutebody indicators0.45 indicators/minute
Group of Subjects Presenting Major Depression MDIndicators / Minutebody indicators0.59 indicators/minute
Group of Subjects Presenting Major Depression MDIndicators / Minutevocal indicators0.23 indicators/minute
Group of Subjects Presenting Major Depression MDIndicators / Minutefacial indicators0.4975 indicators/minute
Group of Subjects Without Psychiatric Troubles CIndicators / Minutefacial indicators0.45 indicators/minute
Group of Subjects Without Psychiatric Troubles CIndicators / Minutevocal indicators0.4 indicators/minute
Group of Subjects Without Psychiatric Troubles CIndicators / Minutebody indicators0.55 indicators/minute
p-value: 0.992Wilcoxon (Mann-Whitney)
p-value: 0.8Wilcoxon (Mann-Whitney)
p-value: 0.586Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026