Telehealth Mindfulness for Post-Surgical Pain

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Psychosis, Dementia, Bipolar, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

72 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two support methods for patients after spine surgery. It targets patients with degenerative spine conditions to see if these methods help with pain and recovery. Mindfulness helps manage pain by focusing on the present, while education helps by providing useful information.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on behavioral interventions and does not mention medication changes.

What data supports the idea that Telehealth Mindfulness for Post-Surgical Pain is an effective treatment?

The available research shows that mindfulness-based interventions (MBIs) are effective for people with physical health conditions, including chronic pain. One study found that a 4-week mindfulness program significantly reduced stress and improved attention in nurses, suggesting that similar benefits could apply to post-surgical pain. Although specific data on post-surgical pain is not provided, the effectiveness of MBIs for chronic pain and stress reduction indicates potential benefits for post-surgical pain management. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Telehealth Mindfulness-Based Intervention (MBI) for post-surgical pain?

Research shows that mindfulness-based interventions (MBIs) can effectively reduce stress and improve attention in healthcare professionals, and they are also used to manage chronic pain. While specific data on post-surgical pain is limited, the success of MBIs in similar contexts suggests potential benefits for post-surgical pain management. ^{1 2 3 4 5}

Is telehealth mindfulness safe for humans?

Mindfulness-based interventions (MBIs), including those delivered via telehealth, are generally considered safe for humans, as they are widely used in both clinical and non-clinical settings without significant reports of harm. ^{1 2 3 4 6}

What safety data exists for telehealth mindfulness interventions for post-surgical pain?

The available research on mindfulness-based interventions (MBIs), including telehealth and web-based formats, suggests they are generally well-received and effective in reducing stress and improving mindfulness in various populations, such as nurses and individuals with chronic conditions. However, specific safety data on adverse effects is limited, as highlighted by a study on MBIs in bipolar disorder, which notes that potential adverse effects have not been extensively studied. Overall, while MBIs are increasingly used and show promise, more robust clinical research is needed to fully understand their safety profile, especially in the context of post-surgical pain. ^{1 2 3 4 6}

Is Telehealth Mindfulness-Based Intervention a promising treatment for post-surgical pain?

Yes, Telehealth Mindfulness-Based Intervention is a promising treatment for post-surgical pain. It is a non-drug approach that helps people manage pain by focusing on the present moment without judgment. Studies show that mindfulness can improve pain tolerance and reduce stress, making it a valuable tool for people recovering from surgery. Additionally, using technology like apps makes it more accessible and convenient for patients. ^{1 2 5 7 8}

How is the Telehealth Mindfulness-Based Intervention (MBI) treatment for post-surgical pain different from other treatments?

The Telehealth Mindfulness-Based Intervention (MBI) is unique because it offers a non-drug approach to managing post-surgical pain through mindfulness practices delivered remotely, which can be more accessible and convenient for patients compared to traditional in-person sessions. This approach focuses on improving mental health and stress levels, potentially enhancing pain tolerance and reducing pain intensity without the use of medications. ^{1 2 5 7 8}

Research Team

Carrie E Brintz, PhD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

This trial is for English-speaking adults over 18 who are having their first lumbar spine surgery at Vanderbilt Spine Center due to degenerative conditions like spinal stenosis. They must have had back or leg pain for at least 3 months, be able to attend weekly online sessions post-surgery, and have stable internet access. People with certain psychiatric disorders, substance use issues, severe brain injuries, or those undergoing microsurgical techniques are excluded.

Inclusion Criteria

I can attend weekly online sessions with a therapist for 8 weeks after surgery.

I am scheduled for spine surgery at Vanderbilt Spine Center.

I have a spine condition like spinal stenosis or spondylosis.

Exclusion Criteria

You have had bipolar disorder or dissociative disorder in the past.

I am having surgery to correct a spinal deformity.

You have been using drugs or alcohol heavily in the past month.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or phone)

Preoperative Assessment

Participants complete self-report questionnaires and sensory pain tasks online before spine surgery

1 week

Online assessments

Postoperative Intervention

Participants are randomly assigned to either Mindfulness or Education intervention and attend 8 weekly telehealth sessions

8 weeks

8 visits (virtual)

Follow-up

Participants are monitored for pain-related, functional, opioid use, and psychosocial outcomes at 3 and 6 months after surgery

6 months

Online assessments at 3 and 6 months

Treatment Details

Interventions

• Telehealth Education
• Telehealth mindfulness-based intervention (MBI)

Trial Overview The study compares two telehealth interventions after lumbar spine surgery: mindfulness-based intervention (MBI) and education. Participants will complete questionnaires and a sensory pain task before and several times after surgery. Post-surgery, they'll randomly receive either MBI or educational sessions via telehealth once a week for eight weeks to assess pain management and recovery outcomes.

Participant Groups

Group I: Telehealth mindfulness-based intervention (MBI) Experimental Treatment 1 Intervention

Eight, weekly telehealth mindfulness sessions delivered one-on-one with mindfulness instructor

Group II: Telehealth Education (EDU) Active Control 1 Intervention

Eight, weekly post-surgical educational sessions delivered one-on-one with physical therapist

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+

Findings from Research

A review of 16 studies involving Web-based mindfulness-based interventions (MBIs) for people with chronic physical health conditions showed positive effects on outcomes like pain acceptance and depressive symptoms compared to usual care.

Condition-specific symptoms, such as cancer-related fatigue and irritable bowel syndrome (IBS) symptoms, showed the largest improvements, indicating that tailored Web-based MBIs may effectively alleviate symptom burden for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for People With Physical Health Conditions: Systematic Review. Toivonen, KI., Zernicke, K., Carlson, LE.[2018]

A 4-week mindfulness-based intervention (MBI) significantly reduced perceived stress and improved mindful attention among 15 nurses, as shown by pre- and post-intervention surveys.

The program was conducted asynchronously and remotely, making it a practical option for future mindfulness interventions in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Asynchronous Evidence-Based Mindfulness Intervention for Professional Nurses. Ficarra, ME.[2023]

Mindfulness-Based Interventions (MBIs) have been shown to be effective for patients with both psychiatric issues and chronic physical health conditions, highlighting their versatility in healthcare.

Despite their proven benefits, the adoption of MBIs in clinical settings is slow, necessitating better integration into medical education, more qualified instructors, and further research on their effectiveness and mechanisms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[How can mindfulness contribute to health care?] Speckens, AEM., Cillessen, L.[2021]

Internet-supported mindfulness-based interventions (MBIs) were found to be more effective than usual care or wait-list groups, indicating their potential as a beneficial treatment for individuals with chronic conditions.

Self-guided MBIs showed similar effectiveness to facilitator-guided interventions, suggesting that individuals can successfully engage with these programs independently, although adherence definitions varied across studies, complicating comparisons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Characteristics and Dissemination Indicators to Optimize Delivery of Internet-Supported Mindfulness-Based Interventions for People With a Chronic Condition: Systematic Review. Russell, L., Ugalde, A., Milne, D., et al.[2020]

The study will evaluate two innovative mindfulness-based interventions (MBIs) for chronic pain management in Veterans, aiming to overcome implementation barriers associated with traditional mindfulness-based stress reduction.

The trial will compare the effectiveness of a group-based MBI (Mobile+Group LAMP) and an individual MBI (Mobile LAMP) against usual care, measuring outcomes like pain interference and mental health over 12 months, which could lead to improved treatment options for Veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. Burgess, DJ., Evans, R., Allen, KD., et al.[2022]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

Mindfulness-based interventions (MBIs) significantly reduce pain intensity in chronic pain patients, with 10 out of 16 studies showing decreased pain ratings, especially in clinical pain samples.

Most controlled trials indicated that MBIs led to greater reductions in pain intensity compared to control groups, and these benefits were generally maintained in follow-up assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. Reiner, K., Tibi, L., Lipsitz, JD.[2022]

A study involving surgical patients with chronic pain showed that 71% of participants used a mindfulness meditation app at least once during a 6-week period, indicating a strong interest in mindfulness-based interventions (MBIs) for pain management.

Despite the high interest, only 8% of patients adhered to the recommended usage of 10 minutes per day, highlighting the need to identify barriers to compliance in order to effectively implement non-pharmacologic pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. Diller, ML., Mascaro, J., Haack, C., et al.[2022]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Interventions for People With Physical Health Conditions: Systematic Review. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

An Asynchronous Evidence-Based Mindfulness Intervention for Professional Nurses. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[How can mindfulness contribute to health care?] [2021]

4. Canada pubmed.ncbi.nlm.nih.gov

Digital Characteristics and Dissemination Indicators to Optimize Delivery of Internet-Supported Mindfulness-Based Interventions for People With a Chronic Condition: Systematic Review. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Learning to Apply Mindfulness to Pain (LAMP): Design for a Pragmatic Clinical Trial of Two Mindfulness-Based Interventions for Chronic Pain. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Do mindfulness-based interventions reduce pain intensity? A critical review of the literature. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adherence Patterns and Acceptability of a Perioperative, App-Based Mindfulness Meditation Among Surgical Patients With Chronic Pain. [2022]