Validation of the French Version of the Pain Sensitivity Questionnaire (PSQ-F)

May 23, 2019 updated by: University Hospital, Clermont-Ferrand
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

232

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: healthy volunteers
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.
EXPERIMENTAL: scheduled surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The psychometric properties of the French version of the PSQ
Time Frame: at day 1
(acceptability, internal validity, reproducibility, convergent validity and validity of structure against external criteria)
at day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The natural smell sensitivity assessed independently by a home-made questionnaire
Time Frame: at day 1
one measurement point
at day 1
The natural noise sensitivity assessed independently by a home-made questionnaire
Time Frame: at day 1
one measurement point
at day 1
The natural light sensitivity, assessed independently by a home-made questionnaire
Time Frame: at day 1
one measurement point
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Centre Jean Perrin
Inserm U1107 " Neuro-Dol ", Clermont-Ferrand, France
Klinikum der Universität München, Deutschland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 30, 2017

Primary Completion (ACTUAL)

January 23, 2018

Study Completion (ACTUAL)

January 23, 2018

Study Registration Dates

First Submitted

March 20, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (ACTUAL)

April 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-311
  • 2016-A02079-42 (OTHER: 2016-A02079-42)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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