Validation of the French Version of the Pain Sensitivity Questionnaire

NCT ID: NCT03113903

Last Updated: 2019-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-30

Study Completion Date

2018-01-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Scheduled Surgery Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
open

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

scheduled surgery

Group Type EXPERIMENTAL

Psychophysical exploration

Intervention Type BEHAVIORAL

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.

healthy volunteers

Group Type OTHER

Psychophysical exploration

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Inserm U1107 " Neuro-Dol ", Clermont-Ferrand, France

UNKNOWN

Sponsor Role collaborator

Centre Jean Perrin

OTHER

Sponsor Role collaborator

Klinikum der Universität München, Deutschland

UNKNOWN

Sponsor Role collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christian DUALE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 31020630 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34554698 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-A02079-42

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-311

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

3h of PNE on BDNF and Pain Levels
NCT05736172 RECRUITING NA