Online mindfulness-based cognitive therapy for Heart Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tallahassee Memorial Hospital, Tallahassee, FL
Heart Diseases+5 More
Online mindfulness-based cognitive therapy - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

Online Mindfulness-based Intervention to Prevent Chronic Pain

See full description

Eligible Conditions

  • Heart Diseases
  • Pain, Acute
  • Catastrophizing, Pain
  • Chronic Pain
  • Pain, Postoperative

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Online mindfulness-based cognitive therapy will improve 2 primary outcomes, 3 secondary outcomes, and 4 other outcomes in patients with Heart Diseases. Measurement will happen over the course of immediately after intervention.

during the intervention, immediately after intervention, through study completion, an average of six months
Treatment adherence
Treatment dosage
during the intervention, through study completion, an average of six months
Incidence of refusal and dropout
immediately after intervention
Patient perception of the intervention's effectiveness, appropriateness, suitability and willingness to adhere
Month 6
Change from Baseline Mindfulness at 6 months
Change from Baseline Pain catastrophizing at 6 months
Change from baseline Chronic pain acceptance at 6 months
Change from baseline Pain Intensity at 6 months
Change from baseline Pain interference at 6 months

Trial Safety

Trial Design

2 Treatment Groups

Online standardized education
1 of 2
Online Mindfulness-based intervention
1 of 2
Active Control
Experimental Treatment

This trial requires 32 total participants across 2 different treatment groups

This trial involves 2 different treatments. Online Mindfulness-based Cognitive Therapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Online Mindfulness-based intervention
Behavioral
Four weekly sessions are planned. The first session will focus on providing feedback regarding post-surgical pain. The second session will focus on teaching mindfulness strategies. The third session will focus on practicing one of the two strategies. Of note, sessions 2 and 3 will start with cognitive restructuring strategies. The 4th session consists in a booster providing feedback and reminders about cognitive reactions to pain and mindfulness meditation. The participants will be asked to practice meditation 5 days a week, for a total of 4 weeks
Online standardized education
Behavioral
In addition to usual care, the CG will have access to one 15-minute standardized educational online session on persistent post-surgical pain, how pain and stress may interact and their potential impact on recovery.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-intervention, immediately after the intervention, 3 months after surgery, and 6 months after surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly pre-intervention, immediately after the intervention, 3 months after surgery, and 6 months after surgery for reporting.

Who is running the study

Principal Investigator
G. M.
Prof. Geraldine Martorella, Associate Professor
Florida State University

Closest Location

Tallahassee Memorial Hospital - Tallahassee, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
age ≥ 18 years
first-time elective CABG and/or VR via a median sternotomy OR total knee or hip replacement
presence of pain at movement ≥4/10
ability to understand and complete questionnaires in English
You have the ability to use an electronic device such as a smartphone, computer or tablet. show original

Patient Q&A Section

Who should consider clinical trials for pain, postoperative?

"It seems that there may be benefit in enrolling patients with chronic pain in clinical trials, though this is controversial owing to the potential of the study procedures." - Anonymous Online Contributor

Unverified Answer

What are the signs of pain, postoperative?

"This review provides a comprehensive overview of postoperative symptoms from the perspectives of those experiencing pain following surgical procedures. Postoperative pain is common and is of great importance to those who experience a surgical procedure. It has a profound and lasting impact on quality of life and can cause substantial economic costs. Clinical pain and other symptoms of postoperative complications such as nausea, vomiting, fatigue, and sleep disturbance should be managed appropriately." - Anonymous Online Contributor

Unverified Answer

What causes pain, postoperative?

"Postoperative pain is the most common reason for a patient to visit the doctor for follow up care. Although there are several causes for this pain, the most common complaint is that of pain following surgery. The best available science indicates that prevention and treatment based on pain science will reduce pain and improve health care outcomes. The most effective techniques include the use of medication, behavior modification instructions, patient selection, and care coordination with support from nurses, physicians, or other health care providers. It has been demonstrated that for the pain sufferer, the experience of pain itself is aversive. This can be reduced by reducing physiological arousal, use of pain medication, and use of pain-reduction techniques such as distraction." - Anonymous Online Contributor

Unverified Answer

How many people get pain, postoperative a year in the United States?

"Pain, postoperative, affects a large number of people in the United States. While the most affected are women and white, the highest incidence occurs in those of African descent and African American women." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pain, postoperative?

"While many conditions can cause [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain), the treatment of pain is dependent on the type of pain and how advanced the condition is. Pain management may include use of drugs, dietary and exercise modifications, psychological modification, psychotherapy, and surgical interventions. Specific intervention types depend on a patient's level of pain, preferences, and the nature of the condition.\n" - Anonymous Online Contributor

Unverified Answer

What is pain, postoperative?

"Postoperative pain occurs in the early hours following surgery in approximately 90 percent of patients. This pain is generally mild. Most postoperative pain disappears within one to two days after surgery." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets pain, postoperative?

"Most patients (98%) with an esophageal cancer had postoperative pain with moderate-to-good pain scores on the day of surgery, and the majority had mild/moderate postoperative pain scores the first postoperative day. The average pain scores on the day of surgery and the first postoperative day were 7 and 3.5 on the 0 to 10 scale, respectively. Almost 6% of patients (14 of 220) had pain scores greater than 12 on the 10-point VAS." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving online mindfulness-based cognitive therapy?

"This research represents the first investigation of an MMBS based CT in terms of a clinical trial and demonstrates the potential of online-based MMBS-CT in reducing levels of disability and overall stress. As a result, online training programmes combining mindfulness-related strategies are increasingly recommended to patients and their healthcare professionals. This is particularly helpful if patients have limited access to formal rehabilitation. Nonetheless, there is some scope for further research in this area, combining mindfulness-based approaches with more formal clinical models of CT, to produce improved results." - Anonymous Online Contributor

Unverified Answer

How serious can pain, postoperative be?

"Pain management must address both the underlying pain and the consequences of the pain. While the management of pain is a complex and challenging issue, effective pain management and control will help the patient recover and be able to function better. Postoperative pain is usually difficult to control using standard analgesics and can be serious. The use of paracetamol, non-steroidal anti-inflammatory drugs, or non-opioid analgesics at the initiation of pain management will help reduce and control the pain associated with procedures. It will also help to reduce the risk of [postoperative nausea after surgery] (http://med.emory.edu/surgical/Pages/Postoperatives/Postoperative-Drugs." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating pain, postoperative?

"The treatment of postoperative pain has been improving every year; however, postoperative pain remains a big problem in modern healthcare. There are very few medicines on the market that have been prescribed specifically for treating pain on the same day of surgery. The number of anti-nociceptive drugs is also very limited, with only five approved drugs currently in use in the US. Even though there is evidence supporting multiple factors that affect the development and maintenance of postoperative pain, research has been focused on pain arising due to cancer. Results from a recent clinical trial of this research do show that research targeting cancer pain is crucial, as it is one of the most prevalent and serious types of pain." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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