NCT06811103 DEterminants of Decisional Autonomy In Chronic Pain Patients and Assessment of Treatment Effectiveness
| NCT ID | NCT06811103 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Hôpital Saint-Joseph |
| Condition | Chronic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2025-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Chronic pain is defined as an unpleasant sensory and emotional experience that persists for three months or more, affecting 20-30% of the global adult population. It can arise from primary conditions or as a consequence of diseases and is a significant source of disability. Chronic pain is no longer merely a symptom but often a disease itself, with neurological and psychosocial mechanisms. The biopsychosocial model introduced by George Engel in 1977 helps to consider the biological, psychological, social, and societal dimensions of chronic pain. Patients with chronic pain must adapt to new circumstances, acquiring new knowledge and coping skills to reach a new homeostasis. The goal is not necessarily pain elimination but enabling patients to manage their pain and continue daily activities effectively. International guidelines suggest a patient-centered, interdisciplinary approach to managing chronic pain, with an emphasis on empowering patients, motivating them, and involving them in decision-making. Autonomy in decision-making is crucial in this context, encompassing both negative freedom (absence of external constraints) and positive freedom (the ability to make choices and realize one's potential). However, chronic pain can limit cognitive and functional abilities, potentially impeding a patient's autonomy. Research indicates that a significant proportion of chronic pain patients experience a deficit in decision-making autonomy. This mixed-methods study aims to explore the determinants of decision-making autonomy in chronic pain patients and its impact on their treatment. Using the MacCAT-T assessment tool, which evaluates understanding, reasoning, appreciation, and choice expression, the study will examine the relationship between patients' autonomy levels and their health outcomes. The study will also assess how clinicians perceive patients' autonomy compared to the tool's findings.
Eligibility Criteria
Inclusion Criteria: * Patient aged 18 years or older * Patient attending their first consultation for chronic pain between 01/01/2025 and 31/12/2025 * Francophone patient * Patient capable of expressing their non-opposition to participation Exclusion Criteria: * Patient with significant visual or hearing impairment * Patient under guardianship or curatorship * Patient deprived of liberty * Patient under judicial protection Patient who opposes the use of their data for this research
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06811103 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06811103 currently recruiting?
Yes, NCT06811103 is actively recruiting participants. Contact the research team at mdussel@ghpsj.fr for enrollment information.
Where is the NCT06811103 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06811103 clinical trial?
NCT06811103 is sponsored by Fondation Hôpital Saint-Joseph. The trial plans to enroll 200 participants.
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