Validation of the French Version of the Pain Sensitivity Questionnaire

Healthy Volunteers Clinical Trial

— PSQ-F  

Official title:

Validation of the French Version of the Pain Sensitivity Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03113903
• Other study ID #: CHU-311
• Secondary ID: 2016-A02079-42
• Status: Completed
• Phase: N/A
• Start date: April 30, 2017
• Est. completion date: January 23, 2018

Study information

• Verified date: November 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: January 23, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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:

-

Related Conditions & MeSH terms

• Healthy Volunteers
• Hypersensitivity
• Scheduled Surgery

Intervention

Behavioral:
• Psychophysical 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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Centre Jean Perrin, Inserm U1107 « Neuro-Dol », Clermont-Ferrand, France, Klinikum der Universität München, Deutschland

Country where clinical trial is conducted

France, 

References & Publications (1)

Dualé 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 Apr 24. doi: 10.1007/s12630-019-01377-w. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The psychometric properties of the French version of the PSQ	(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)	at day 1
Secondary	The natural smell sensitivity assessed independently by a home-made questionnaire	one measurement point	at day 1
Secondary	The natural noise sensitivity assessed independently by a home-made questionnaire	one measurement point	at day 1
Secondary	The natural light sensitivity, assessed independently by a home-made questionnaire	one measurement point	at day 1