CompletedNot Applicable

Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment

Germany3,322 participantsStarted 2019-09-24

Plain-language summary

PROMPT aims at improving management of acute and chronic pain by identifying a core set of PROMs (patient reported outcome measures) that are predictive indicators of treatment success in clinical practice and controlled trials. These will not only address pain intensities as well as the functional consequences of pain for individuals but also identify patients at risk of experiencing chronification of acute post-operative pain. Results will help health care professionals to individualize pain management, and thus improve the quality of life of pain patients.

Who can participate

Age range

18 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: * Patient is of consenting age (\>18 years old) * Elective surgery * Planned stay in hospital for the surgery * First contact with the patient before surgery * Patient agrees to participate Exclusion Criteria: * Patient is unable to give consent * Cognitive impairment * Questionnaire is not available in a language the patient is fluent in * Patient not willing to answer the follow-up questionnaire

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

WP 2 - Acute pain: Sensitivity to change

Timeframe: 2019 - 2022

WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)

Timeframe: 2019 - 2022

Trial details

NCT IDNCT03834922

SponsorProf. Dr. Winfried Meissner

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Pain, Postoperative trials