Validation of the French Version of the Pain Sensitivity Questionnaire

Not Applicable

Completed

• Conditions: Scheduled Surgery; Healthy Volunteers
• Interventions: Behavioral: Psychophysical exploration

• Registration Number: NCT03113903
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-14
• Study Start: 2017-04-30
• Primary Completion: 2018-01-23
• Study Completion: 2018-01-23
• Status Verified: 2018-11
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
scheduled surgery	Psychophysical exploration	-
healthy volunteers	Psychophysical exploration	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France