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: Unknown

73 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial tests a digital meditation for postoperative pain control after abdominal surgery for cancer. Mindfulness interventions such as guided meditation may improve pain control and decrease stress. Including a brief mindfulness intervention administered via test messages as part of postoperative care may improve pain severity, decrease opioid use, and improve patient responses to non-surgical treatments.

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 data supports the idea that Digital Meditation for Postoperative Pain After Cancer Surgery is an effective treatment?

The available research shows that Digital Meditation, a type of mindfulness-based intervention, is effective in managing pain after surgery. One study found that surgical patients with chronic pain who used a meditation app reported improved mental health and stress levels. Another review highlighted that mindfulness techniques can help reduce pain and the need for opioids after surgery. Additionally, mindfulness-based interventions have been shown to reduce persistent pain in women treated for breast cancer. These findings suggest that Digital Meditation can be a helpful treatment for managing postoperative pain. ^{1 2 3 4 5}

What safety data exists for digital meditation in postoperative pain management?

The safety of digital meditation, or mindfulness-based interventions, has been evaluated in various studies. While mindfulness meditation is generally considered safe and beneficial for managing pain and stress, some studies have reported adverse events such as anxiety and pain, and more severe events like psychosis. However, these severe outcomes are often confounded by factors like the intensity of practice and participants' psychiatric histories. Mindfulness programs like MBSR and MBCT are designed to be adaptable and less intense, minimizing the risk of severe adverse events. Further research is needed to consistently define and report adverse events in mindfulness studies. ^{1 2 6 7 8}

Is digital meditation a promising treatment for pain after cancer surgery?

Yes, digital meditation is a promising treatment for pain after cancer surgery. It can help reduce pain, improve mental health, and lower stress levels. It also offers a non-drug option to manage pain, which can reduce the need for opioids and their associated risks. ^{1 2 4 9 10}

Research Team

Maggie Diller, MD

Principal Investigator

Emory University/Winship Cancer Institute

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. 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]

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

Mindfulness-Based Interventions for Perioperative Pain Management and Opioid Risk Reduction Following Surgery: A Stepped Care Approach. [2022]

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

Preparing for successful surgery: an implementation study. [2022]

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

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

5. England 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. [2018]

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

What Are Adverse Events in Mindfulness Meditation? [2022]

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

The Association Between Mindfulness and Postoperative Pain: A Prospective Cohort Study of Gynecologic Oncology Patients Undergoing Minimally Invasive Hysterectomy. [2020]

8. England 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. [2022]

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

Psychological Methods of Managing Surgical Pain. [2021]

10. United States 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. [2023]