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Past Pain Experience and Perception of Experimental Pain

Past Pain Experience and Perception of Experimental Pain

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01575912
Enrollment
92
Registered
2012-04-12
Start date
2012-03-31
Completion date
2014-01-31
Last updated
2017-06-12

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, Past pain experience

Brief summary

Differences in pain perception between subjects with and without psychiatric illness may be influenced by the individual experience, and not primarily by the pathology, although the pathological frame may amplify it.The aim of this study is to establish if the characteristics of experimental pain feeling are influenced by the past pain experience, anxiety and emotion, independently from the diagnosis. The pain experience will be evaluated by an inventory of the potentially painful situations that one can come across through the life, to determine the following points : Number of painful events in the past, number of painful points during the last 6 months, number of painful events lasting more than 6 months, sum of pain intensities (graduated with Visual Analogic Scale VAS from 0 to 10), sum of gravity (evaluated from 0 to 5), the category of pain experience qualification (mostly affective, mostly sensorial, or both). Schizophrenic, depressed and control participants will be recruited, and their pain experience throughout life will be put it in relation to experimental pain tests results (pressure application, ischemia induction), anxiety and emotion (Hospital Anxiety and Depression scale HAD), catastrophizing (Pain Catastrophizing Scale PCS), Heart Rate (HR) variation, Blood Pressure (BP) variation.

Detailed description

The perception of moderated experimental pain (about 3 out of ten with visual analogue scale VAS) in subjects with schizophrenia (Girard et coll., 2011), major depression (ED) (bipolar or isolated/recurrent episode) (to be published) in comparison with controls without psychiatric pathologies show that exploration of pain in situation like medical examination to identify painful points should be done in the same conditions for persons with psychiatric troubles and persons without mental disease. But the risk is that the expression of pain, either in experimental conditions nor in the daily life, is not in relation with the feeling or perception of pain. Numerous factors may interfere in the pain message modulation, like the past pain experience, stress and anxiety, which are not or partially explored in experimental studies. The individual experience of pain is constructed throughout the whole life, from several influences (biological, psychological, and sociocultural). The symptoms interfaces of the different psychiatric troubles seem to be widely involved in the pain process, and its progressive construction. This study aims to better understand the relationships between all those variables. Procedures applied : Anterior pain experience evaluation (questionnaire); Pain tests : 160 kPa pressure application to determine corresponding pain with VAS), and ischemia induction to determine the time necessary to obtain a pain equivalent to 3 out of 10; anxiety and emotional evaluation (Hospital Anxiety and Depression scale), catastrophizing evaluation (Pain Catastrophizing Scale), HR variation and BP variation (vegetative measures linked to anxiety) collection of diagnosis, and therapeutic treatment

Interventions

OTHERexperimental pain tests

Sponsors

Centre Hospitalier Esquirol
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

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
Visual Analog Scale Evaluation for the Pre-fixed Pressure Testone monthpain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia. The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain.

Countries

France

Participant flow

Participants by arm

ArmCount
Group of Subjects With Schizophrenia SC
subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
30
Group of Subjects Presenting Major Depression MD
subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
32
Group of Controls Without Psychiatric Disorder
subjects without any psychiatric disorder and submitted to experimental pain tests
30
Total92

Baseline characteristics

CharacteristicGroup of Subjects With Schizophrenia SCGroup of Subjects Presenting Major Depression MDGroup of Controls Without Psychiatric DisorderTotal
Age, Continuous43.3 years
STANDARD_DEVIATION 9.72
44.69 years
STANDARD_DEVIATION 10.08
41.53 years
STANDARD_DEVIATION 10.27
43.21 years
STANDARD_DEVIATION 10
Region of Enrollment
France
30 participants32 participants30 participants92 participants
Sex: Female, Male
Female
7 Participants27 Participants17 Participants51 Participants
Sex: Female, Male
Male
23 Participants5 Participants13 Participants41 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 320 / 30
other
Total, other adverse events
0 / 300 / 320 / 30
serious
Total, serious adverse events
0 / 300 / 320 / 30

Outcome results

Primary

Visual Analog Scale Evaluation for the Pre-fixed Pressure Test

pain tests will be realized during the first week of hospitalization for the persons hospitalized for major depression, and during the period of hospitalization (after stabilization) for the persons presenting schizophrenia. The controls are tested within one month of the study information. total range : 0 - 10. The intensity of pain increases with the value of VAS. 10 corresponds to an unbearable pain.

Time frame: one month

Population: analysis per arm group

ArmMeasureValue (MEAN)Dispersion
Group of Subjects Presenting Schizophrenia SCVisual Analog Scale Evaluation for the Pre-fixed Pressure Test2.8 units on a scaleStandard Deviation 3.2
Group of Subjects With Major Depression MDVisual Analog Scale Evaluation for the Pre-fixed Pressure Test2.1 units on a scaleStandard Deviation 1.8
Group of Subjects Without Psychiatric Troubles CVisual Analog Scale Evaluation for the Pre-fixed Pressure Test1.2 units on a scaleStandard Deviation 1.3
p-value: 0.121Wilcoxon (Mann-Whitney)

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