Back to resultsValidation of the French Version of the Pain Sensitivity Questionnaire (PSQ-F)
Primary Purpose
Scheduled Surgery, Healthy Volunteers
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Psychophysical exploration
Sponsored by
About this trial
This is an interventional other trial for Scheduled Surgery focused on measuring Pain, psychophysics, Nociception, Sensitivity, Senses, Phenotyping, Questionnaire, Anxiety, Depression, Catastrophizing
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:
-
Sites / Locations
- CHU Clermont-Ferrand
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
scheduled surgery
healthy volunteers
Arm Description
Outcomes
Primary Outcome Measures
The psychometric properties of the French version of the PSQ
(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)
Secondary Outcome Measures
The natural smell sensitivity assessed independently by a home-made questionnaire
one measurement point
The natural noise sensitivity assessed independently by a home-made questionnaire
one measurement point
The natural light sensitivity, assessed independently by a home-made questionnaire
one measurement point
Full Information
NCT ID
NCT03113903
First Posted
March 20, 2017
Last Updated
May 23, 2019
Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Inserm U1107 " Neuro-Dol ", Clermont-Ferrand, France, Centre Jean Perrin, Klinikum der Universität München, Deutschland
1. Study Identification
Unique Protocol Identification Number
NCT03113903
Brief Title
Validation of the French Version of the Pain Sensitivity Questionnaire
Acronym
PSQ-F
Official Title
Validation of the French Version of the Pain Sensitivity Questionnaire
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 30, 2017 (Actual)
Primary Completion Date
January 23, 2018 (Actual)
Study Completion Date
January 23, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
Collaborators
Inserm U1107 " Neuro-Dol ", Clermont-Ferrand, France, Centre Jean Perrin, Klinikum der Universität München, Deutschland
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scheduled Surgery, Healthy Volunteers
Keywords
Pain, psychophysics, Nociception, Sensitivity, Senses, Phenotyping, Questionnaire, Anxiety, Depression, Catastrophizing
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
open
Allocation
Non-Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
scheduled surgery
Arm Type
Experimental
Arm Title
healthy volunteers
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Psychophysical exploration
Intervention Description
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.
Primary Outcome Measure Information:
Title
The psychometric properties of the French version of the PSQ
Description
(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
The natural smell sensitivity assessed independently by a home-made questionnaire
Description
one measurement point
Time Frame
at day 1
Title
The natural noise sensitivity assessed independently by a home-made questionnaire
Description
one measurement point
Time Frame
at day 1
Title
The natural light sensitivity, assessed independently by a home-made questionnaire
Description
one measurement point
Time Frame
at day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian DUALE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
31020630
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.
Results Reference
background
PubMed Identifier
34554698
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.
Results Reference
derived
Learn more about this trial
Validation of the French Version of the Pain Sensitivity Questionnaire
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