Clinical trial NCT03113903: Validation of the French Version of the Pain Sensitivity Questionnaire
Official title: Validation of the French Version of the Pain Sensitivity Questionnaire
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scheduled Surgery
Healthy Volunteers
Keywords: Pain
psychophysics
Nociception
Sensitivity
Senses
Phenotyping
Questionnaire
Anxiety
Depression
Catastrophizing
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Inserm U1107 " Neuro-Dol ", Clermont-Ferrand, France
name: Centre Jean Perrin
name: Klinikum der Universität München, Deutschland
First posted: 2017-04-14
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Exclusion Criteria:

-

Primary outcomes:
measure: The psychometric properties of the French version of the PSQ
timeFrame: at day 1
Secondary outcomes:
measure: The natural smell sensitivity assessed independently by a home-made questionnaire
timeFrame: at day 1
measure: The natural noise sensitivity assessed independently by a home-made questionnaire
timeFrame: at day 1
measure: The natural light sensitivity, assessed independently by a home-made questionnaire
timeFrame: at day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Christian DUALE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duale C, Bauer U, Storme B, Eljezi V, Ruscheweyh R, Eschalier S, Dubray C, Guiguet-Auclair C. Transcultural adaptation and French validation of the Pain Sensitivity Questionnaire. Can J Anaesth. 2019 Oct;66(10):1202-1212. doi: 10.1007/s12630-019-01377-w. Epub 2019 Apr 24.
citation: Duale C, Leray V, Giron F, Boulliau S, Macian N, Ruscheweyh R, Dubray C, Giraudet F. The Added Value of Sensitivity to Nonnoxious Stimuli to Predict an Individual's Sensitivity to Pain. Pain Physician. 2021 Sep;24(6):E783-E794.