CompletedNot Applicable

Validation of the French Version of the Pain Sensitivity Questionnaire

France232 participantsStarted 2017-04-30

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The psychometric properties of the French version of the PSQ

Timeframe: at day 1

Trial details

NCT IDNCT03113903

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-01-23

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