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Online Mindfulness-based Intervention to Prevent Chronic Pain
NCT04848428 · View on ClinicalTrials.gov ↗
Study Summary
Cardiac and orthopedic surgeries are frequent procedures. However, pain after a major surgery may become chronic (lasting \>3 months) in adults. Once discharged from the hospital, patients are at risk for chronic post-surgical pain (CPSP) and prolonged opioid use, as they become isolated with high levels of pain. Psychological risk and protective factors such as pain-related catastrophic thoughts and pain acceptance will determine their ability to cope and their opioid use, which makes a support for pain self-management crucial. There is limited research on psychological interventions for pain in the subacute/rehabilitation phase after major surgery. Further, these interventions are demanding and not tailored. Previous work from the Principal Investigator in the acute/hospitalization phase shows that a brief, Web-based intervention tailored to modifiable psychological factors may modulate these and reduce postoperative pain interference. Recently, studies on mindfulness-based cognitive therapy (MBCT) have multiplied regarding their potential effect on pain acceptance and catastrophic thoughts. Brief, Web-based MBCT for the prevention of CPSP have not been examined. Therefore, a pilot test of a 4-week tailored, Web-based MBCT intervention for adults in the rehabilitation phase will be conducted by 1) assessing the acceptability/feasibility of the intervention; and 2) examining preliminary effects on pain intensity and pain interference with activities, as well as pain acceptance and catastrophic thoughts. This research is significant because it targets the trajectory of CPSP, a leading cause of disability and opioid misuse. This approach is innovative because it promotes pain self-management through the modulation of individual factors. If successful, the intervention could be expanded to numerous populations at risk for chronic pain.
Conditions Studied
Interventions
- BEHAVIORAL Online mindfulness-based cognitive therapy
- BEHAVIORAL Online standardized education
Study Locations (1)
Florida
- Tallahassee Memorial Hospital — Tallahassee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-05-01 |
| Est. Completion | 2022-11-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04848428
The ClinicalTrials.gov registry entry for NCT04848428 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Florida State University, which has 291 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Chronic Pain appearing as the primary indexed condition, and to 2 interventions — of which Online mindfulness-based cognitive therapy is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04848428 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04848428 about?
NCT04848428 is a clinical study titled "Online Mindfulness-based Intervention to Prevent Chronic Pain". Cardiac and orthopedic surgeries are frequent procedures. However, pain after a major surgery may become chronic (lasting \>3 months) in adults. Once discharged from the hospital, patients are at risk for chronic post-surgical pain (CPSP) and prolonged opioid use, as they become isolated with high l...
What is the current status of trial NCT04848428?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2021-05-01. Estimated completion is 2022-11-29.
What conditions does trial NCT04848428 study?
This clinical trial studies the following conditions: Chronic Pain, Pain, Postoperative, Pain, Acute, Pain Catastrophizing. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04848428?
The interventions under investigation include: Online mindfulness-based cognitive therapy (BEHAVIORAL), Online standardized education (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04848428?
This trial is sponsored by Florida State University, which has 291 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04848428 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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