Online Mindfulness-based Intervention to Prevent Chronic Pain

NCT04848428 | Completed

• 1 other identifier: 046073
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Pain, Postoperative; Chronic Pain; Pain Catastrophizing; Pain, Acute

Keywords

postoperative pain; mindfulness; chronic pain

Outcome Measures

Primary Outcomes (2)

• Change from baseline Pain Intensity after intervention

  0-10 Numerical Rating Scale (Brief Pain Inventory)

  pre-intervention, immediately after the intervention

• Change from baseline Pain interference after intervention

  0-10 Numerical Rating Scale (Brief Pain Inventory) several daily activities such as housework, sleep, etc

  pre-intervention, immediately after the intervention

Secondary Outcomes (3)

• Change from Baseline Mindfulness after intervention

  pre-intervention, immediately after the intervention

• Change from baseline Chronic pain acceptance after intervention

  pre-intervention, immediately after the intervention

• Change from Baseline Pain catastrophizing after intervention

  pre-intervention, immediately after the intervention

Other Outcomes (4)

• Patient perception of the intervention's effectiveness, appropriateness, suitability and willingness to adhere

  immediately after intervention

• Incidence of refusal and dropout

  during the intervention, through study completion (1 month)

• Treatment dosage

  during the intervention, immediately after intervention, through study completion (1 month)

Study Arms (2)

Online Mindfulness-based intervention

EXPERIMENTAL

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

Behavioral: Online mindfulness-based cognitive therapy

Online standardized education

ACTIVE COMPARATOR

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.

Behavioral: Online standardized education

Interventions

Online mindfulness-based cognitive therapy BEHAVIORAL

The first session will first 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 for the moderate-high risk profile patients. 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

Also known as: Online MBCT

Online Mindfulness-based intervention

Online standardized education BEHAVIORAL

One 15-minute educational session on postoperative pain, the relationship between pain, thoughts and emotions and brief overview of strategies.

Online standardized education

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ability to use an electronic device such as a smartphone, computer or tablet

You may not qualify if:

• \- unable to consent because of physical or mental incapacity.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Tallahassee Memorial Hospital

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Geraldine Martorella, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 2-arm pilot RCT

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: May 1, 2021
• Primary Completion: August 29, 2022
• Study Completion: November 29, 2022
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (1)