Healthy Volunteers, Scheduled Surgery
Conditions
Keywords
Pain, psychophysics, Nociception, Sensitivity, Senses, Phenotyping, Questionnaire, Anxiety, Depression, Catastrophizing
Brief summary
The Pain Sensitivity Questionnaire (PSQ) is a tool created in 2009 by Dr. R. Ruscheweyh in Germany. It aims at identifying the natural sensitivity to pain, through a set of 17 simple questions. These questions simulate daily life situations likely to induce pain of various intensities. The internal validity of the tool had been demonstrated both for the original version in German, and then for its English version. The external validity had also been demonstrated by correlation to real nociceptive stimulations applied to healthy volunteers (German version), and to patients before surgery (English version). A French validation of the questionnaire is needed, in order to integrate it in pain research programs in French-speaking countries.
Detailed description
The aim is to validate the French version of the PSQ in a 2-step plan : (i) validity of internal structure, convergent validity and reproducibility, in a sample of patients before scheduled surgery, and (ii) structure and convergent validity against external criterion, in healthy volunteers. A secondary objective is to study the relationship of scores of the PSQ with a scale assessing sensitivity to natural smells, noise and light sensitivity.
Interventions
BEHAVIORALPsychophysical exploration
Psychophysical exploration (multimodal sensitivity, including pain sensitivity) Electronic von Frey applied on forearm; thermal heat applied on forearm; foot immersion in 2°C cold water; exposure to a one-frequency noise up to uncomfortable loudness ; exposure to a halogen-lamp-generated light up to uncomfortable brightness.
Sponsors
University Hospital, Clermont-Ferrand
Inserm U1107 " Neuro-Dol ", Clermont-Ferrand, France
Centre Jean Perrin
Klinikum der Universität München, Deutschland
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
open
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* patients aged 18 to 65, currently French-speaking and able to answer questionnaires, undergoing a pre-anesthetic mandatory visit, either for scheduled surgery, or as a follow-up of pregnancy * healthy volunteers aged 18 to 60, currently French-speaking and able to answer questionnaires, BMI 19 to 30 kg/m2, free from any medication since 7 days before each study session, covered by the French welfare health system.
Exclusion criteria
are : risk of pregnancy, any medical history or condition likely to impair participation or quality of outcome measurement, any ongoing relevant disease, any cutaneous lesion at nondominant forearm, any ocular, neurological or acoustic contra-indication to the tests, spontaneous tinnitus or disease with hyperacusia, anxiety or depression with score \>11 on HAD, addiction to drugs or alcohol abuse, inclusion in a concomitant trial, French legal protection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The psychometric properties of the French version of the PSQ | at day 1 | (acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The natural smell sensitivity assessed independently by a home-made questionnaire | at day 1 | one measurement point |
| The natural noise sensitivity assessed independently by a home-made questionnaire | at day 1 | one measurement point |
| The natural light sensitivity, assessed independently by a home-made questionnaire | at day 1 | one measurement point |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORChristian DUALE
University Hospital, Clermont-Ferrand
Outcome results
None listed