Digital Meditation for Postoperative Pain After Cancer Surgery

Overseen By Viraj Master, MD PhD FACS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Emory University

Disqualifiers: Contraindications to surgery, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether digital meditation can help manage pain and reduce stress after abdominal cancer surgery. Participants will either receive daily text messages with mindfulness exercises or complete daily pain surveys for 10 days post-surgery. The researchers aim to determine if this digital mindfulness approach can lower pain levels, reduce the need for painkillers, and improve overall recovery. This trial suits individuals who have undergone open abdominal surgery for cancer, own a smartphone capable of texting, and can read and consent to participate. As an Early Phase 1 trial, this research focuses on understanding how digital meditation works in people, offering participants a chance to explore this innovative approach.

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

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that this digital meditation is safe for postoperative pain control?

Research shows that digital meditation, a type of mindfulness practice, can help manage pain after surgery. Studies have found that these practices may lower pain levels and boost well-being. For instance, patients using these techniques often experience less pain and anxiety, especially more than a week after surgery.

Previous research also suggests that mindfulness can help with stress, depression, and overall quality of life. While these studies mainly focus on the benefits, they don't highlight any serious safety issues. Mindfulness practices are generally easy to handle. They don't involve surgery or medication, which means they usually have fewer side effects.

Overall, for those considering joining a trial for digital meditation, current research suggests it is a safe option with potential benefits for managing pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about digital meditation for postoperative pain management after cancer surgery because it offers a non-drug alternative to traditional pain relief methods like opioids and NSAIDs. This approach uses mindfulness techniques delivered via text messages, which can be accessed easily on a smartphone, making it both convenient and accessible. Unlike standard treatments that may have side effects or risk of dependency, digital meditation promotes mental well-being and pain reduction without these concerns. Additionally, this method empowers patients to actively participate in their recovery process from the comfort of their own homes.

What evidence suggests that digital meditation is effective for postoperative pain?

Research has shown that mindfulness activities, such as digital meditation, can help manage post-surgical pain. A review of studies found these practices effectively reduce pain and improve emotional well-being after surgery. Another study found that individuals who practiced mindfulness before surgery experienced less pain afterward. Mindfulness-based cognitive therapy (MBCT) has also demonstrated benefits in helping individuals accept their pain and reduce negative thoughts about it. In this trial, participants in the mindfulness intervention arm will receive digital meditation via text message, which could serve as a helpful tool for controlling pain after cancer surgery. ^{1 5 6 7 8}

Who Is on the Research Team?

Maggie Diller, MD

Principal Investigator

Emory University/Winship Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults who've had open abdominal surgery for cancer, can read, own a smartphone with texting capabilities, and understand the study's risks. They must consent to treatment standards. It's not for those with conditions that rule out abdominal surgery or general anesthesia.

Inclusion Criteria

I had open surgery in my abdomen for cancer.

I understand the study's risks and purposes and agree to participate.

Patients must own a smartphone with iOS or Android operating systems and SMS texting capabilities

Exclusion Criteria

I cannot have abdominal surgery or be put under general anesthesia due to health risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Postoperative Intervention

Participants receive a digital mindfulness intervention or complete a pain survey via text message daily for 10 days after surgery

2 weeks

Daily virtual interactions

Follow-up

Participants complete a telephone interview 2 weeks after surgery and are monitored for safety and effectiveness

2 weeks

1 telephone interview

Long-term Follow-up

Participants' acceptability of the intervention and mode of delivery is assessed using CSQ-8 and SUS over a period of up to 12 months

Up to 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Digital Meditation

Trial Overview The trial is testing a digital meditation program delivered through text messages to help manage pain after cancer-related abdominal surgery. The goal is to see if guided meditation can reduce pain severity, cut down opioid use, and aid in recovery.

How Is the Trial Designed?

Group I: Arm 2 (Mindfulness Intervention) Experimental Treatment 2 Interventions

Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

Group II: Arm I (Pain Survey) Active Control 2 Interventions

Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The digital behavioral pain management intervention 'My Surgical Success' (MSS) was found to be feasible and effective in reducing pain intensity in orthopedic trauma surgery patients, with significant improvements observed up to 3 months post-surgery.

While MSS showed greater reductions in pain intensity compared to a general health education control, it did not significantly affect the time to opioid cessation or pain catastrophizing levels, indicating that while it helps with pain management, it may not influence opioid use or negative pain perceptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"My Surgical Success": Feasibility and Impact of a Single-Session Digital Behavioral Pain Medicine Intervention on Pain Intensity, Pain Catastrophizing, and Time to Opioid Cessation After Orthopedic Trauma Surgery-A Randomized Trial. Ziadni, MS., You, DS., Keane, R., et al.[2023]

Psychological interventions, such as mindfulness and cognitive coaching, can significantly influence analgesic requirements and improve patient outcomes in managing chronic or acute wound pain, suggesting a complementary role alongside traditional pain medications.

Recent systematic reviews indicate that these interventions may enhance patient experiences and clinical outcomes during and after surgical procedures, highlighting their potential effectiveness in pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological Methods of Managing Surgical Pain. Bolton, L.[2021]

In a study of 126 gynecologic oncology patients undergoing minimally invasive hysterectomy, higher preoperative mindfulness was linked to lower postoperative pain scores, suggesting that being more mindful can help manage pain after surgery.

While higher mindfulness was associated with lower pain levels, it did not significantly reduce opioid usage, indicating that mindfulness may improve pain perception but not necessarily decrease the need for pain medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy. Weston, E., Raker, C., Huang, D., et al.[2020]

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]

eHealth mindfulness-based interventions (eHealth-MBIs) showed small but significant improvements in anxiety and depression among cancer patients and survivors, with standardized mean differences of -0.28 and -0.24, respectively, based on a review of 18 studies.

These interventions also positively impacted quality of life and mindfulness in the short term, suggesting they are a cost-effective and accessible option for supporting mental health in cancer care, although the overall quality of evidence was rated low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of eHealth mindfulness-based interventions on cancer-related symptoms among cancer patients and survivors: A systematic review and meta-analysis. Fung, JYT., Lim, H., Vongsirimas, N., et al.[2022]

Mindfulness-based interventions can effectively reduce preoperative pain and anxiety, potentially preventing chronic pain and opioid misuse after surgery, as supported by numerous randomized clinical trials.

A stepped care approach to mindfulness treatment is proposed, where initial brief mindfulness techniques are used for preoperative patients, followed by more extensive interventions for those with ongoing pain or opioid dependence post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Perioperative Pain Management and Opioid Risk Reduction Following Surgery: A Stepped Care Approach. Roberts, RL., Hanley, AW., Garland, EL.[2022]

Approximately 50% of cancer patients experience pain that can lead to a complex state of 'total pain,' which may not respond well to traditional medications.

Mindfulness-based interventions can help patients change their perception of pain, potentially reducing pain catastrophizing and improving overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Hematology and Oncology Patients with Pain. Hess, D.[2019]

A mind-body program using guided imagery and relaxation techniques significantly reduced anxiety levels in surgical patients on the night of their surgery, based on a study of 230 patients undergoing various procedures.

While there was a trend towards lower pain scores and improved sleep quality in the intervention group, these differences were not statistically significant; however, a majority of patients found the program helpful and expressed willingness to use it again for future surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing for successful surgery: an implementation study. Diaz, M., Larsen, B.[2022]

In a study of 129 women with persistent pain after breast cancer treatment, mindfulness-based cognitive therapy (MBCT) significantly reduced pain intensity, particularly in those with higher levels of attachment avoidance.

Radiotherapy may also influence the effectiveness of MBCT, as it was associated with a smaller reduction in pain intensity, suggesting that these factors could help identify patients who would benefit most from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and psychological moderators of the effect of mindfulness-based cognitive therapy on persistent pain in women treated for primary breast cancer - explorative analyses from a randomized controlled trial. Johannsen, M., O'Toole, MS., O'Connor, M., et al.[2018]

Mindfulness meditation, particularly through programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is widely used to treat various conditions such as stress, depression, and chronic pain, but concerns about its safety have emerged due to reported adverse events.

The viewpoint argues that many reported negative experiences during mindfulness meditation, such as anxiety or discomfort, are not true adverse events but rather expected reactions that can occur as individuals learn to manage their mental and physical states; severe outcomes like psychosis are often influenced by external factors rather than the meditation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? Binda, DD., Greco, CM., Morone, NE.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12327906/

Patients' Perception of a Brief Web- and Mindfulness-Based ... This study is part of a pilot RCT that examined the impact of a brief 4-week MBI intervention on pain and other postoperative outcomes [26].

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04848428

Online Mindfulness-based Intervention to Prevent Chronic ... Recently, studies on mindfulness-based cognitive therapy (MBCT) have multiplied regarding their potential effect on pain acceptance and catastrophic thoughts.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155346501930384X

The Association Between Mindfulness and Postoperative ... Our study demonstrates that higher preoperative dispositional mindfulness is associated with more favorable postoperative pain outcomes, including lower pain ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6371675/

A Systematic Review: Mindfulness Intervention for Cancer ... A systematic review was undertaken to describe the effectiveness of mindfulness interventions for pain and its underlying pathophysiologic mechanisms.

5. academic.oup.com academic.oup.com/painmedicine/article/24/Supplement_1/S115/6693630

Effectiveness of a Mindfulness-Based Intervention Integrated ... This study (MIND-PT) is a multisite randomized trial that compares an enriched pain management (EPM) pathway that integrates physical therapy and mindfulness.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04848428?tab=history&a=3

Record History | ver. 3: 2022-01-21 | NCT04848428 Pain intensity, pain interference, mindfulness, pain acceptance, pain-related catastrophic thoughts, and psychological well-being scores will be summarized ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1524904225001572

Effects of Mindfulness on Postoperative Pain, Anxiety, and ... Evidence suggests that mindfulness has a significant impact on postoperative pain, particularly pain more than one week after surgery.

8. researchprotocols.org researchprotocols.org/2021/8/e30951/

Web- and Mindfulness-Based Intervention to Prevent ... Estimates suggest that up to 37% of patients undergoing cardiac surgery have persistent pain and will potentially develop chronic postsurgical ...