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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different telehealth programs to help patients manage pain after lumbar spine surgery for a degenerative spine condition. One group will use mindfulness techniques through a telehealth mindfulness-based intervention (MBI), while the other will receive educational sessions about post-surgery care through a telehealth education intervention. The study aims to determine if these programs can reduce pain, improve function, and decrease the need for pain medications. Individuals experiencing back or leg pain for at least three months and scheduled for their first lumbar spine surgery may be suitable candidates. Participants need a stable internet connection to join weekly online sessions with a coach for eight weeks after surgery. As an unphased trial, this study offers patients the chance to explore innovative telehealth solutions for post-surgery pain management.

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 prior data suggests that these telehealth interventions are safe for post-surgical patients?

Research has shown that telehealth mindfulness-based interventions (MBIs) are generally safe for people. These interventions often help manage pain and are well-received. In one study with about 800 participants, MBIs effectively reduced chronic pain compared to regular care.

MBIs typically include activities like meditation and exercises to increase awareness. These activities have not been known to cause harm, and past studies have reported no serious negative side effects. Participants usually find these sessions helpful and easy to manage.

The telehealth education sessions, used for comparison in this trial, are also considered safe. They involve talking with a therapist about post-surgical care. These sessions are standard practice and carry no known risks.

Overall, both treatments in this trial appear safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these telehealth treatments for post-surgical pain because they offer a unique and accessible approach compared to traditional pain management methods, such as medication or in-person therapy. With the telehealth mindfulness-based intervention (MBI), patients receive personalized, one-on-one mindfulness sessions with an instructor, which can help reduce pain perception by promoting relaxation and mental well-being. Meanwhile, the telehealth education sessions provide valuable post-surgical guidance from a physical therapist, helping patients manage their recovery more effectively without needing to leave their homes. This convenient, remote delivery method could make post-surgical care more accessible and personalized, potentially improving outcomes and patient satisfaction.

What evidence suggests that this trial's interventions could be effective for post-surgical pain?

This trial will compare two approaches: a Telehealth mindfulness-based intervention (MBI) and a Telehealth Education (EDU) program. Studies have shown that mindfulness techniques delivered through telehealth can significantly reduce post-surgery pain. In one study, participants practicing mindfulness experienced a 30% improvement in pain relief at both 10 weeks and 6 months compared to those who did not. Another study found that these techniques also enhanced daily activities related to pain during the same period. This evidence suggests that mindfulness via telehealth can effectively manage pain after spine surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Carrie E Brintz, PhD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12099095/

Feasibility, Acceptability and Modification of a Post-surgical ... A telehealth MBI was delivered one-on-one within 4 weeks after surgery and consisted of 8 weekly sessions modeled after Mindfulness-Based Cognitive Therapy for ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2822046

Telehealth Mindfulness-Based Interventions for Chronic Pain The probability of 30% improvement from baseline compared to control was greater for group MBI at 10 weeks and 6 months, and for self-paced MBI, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05698914

NCT05698914 | Telehealth Mindfulness After Spine Surgery The goal of this pilot clinical trial is to compare two behavioral interventions for patients who are recovering from lumbar spinal surgery for a degenerative ...

4. hsrd.research.va.gov hsrd.research.va.gov/impacts/mbi-pain.cfm

Telehealth Mindfulness-Based Interventions (MBIs) for ... The primary outcome measured was pain-related function, assessed using the Brief Pain inventory interference scale at 10 weeks, six months, and ...

5. jwatch.org jwatch.org/na57836/2024/08/29/do-telehealth-mindfulness-based-interventions-relieve

Do Telehealth Mindfulness-Based Interventions Relieve ... Researchers assessed whether two “scalable, relatively low-resource” 8-week telehealth MBIs improved pain compared with usual care in ≈800 participants.

6. withpower.com withpower.com/trial/phase-low-back-pain-1-2023-fd43b

Telehealth Mindfulness for Post-Surgical Pain Mindfulness-based interventions (MBIs), including those delivered via telehealth, are generally considered safe for humans, as they are widely used in both ...