Mindfulness Training for Postoperative Pain

Overseen By Kari M Plewniak, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Disqualifiers: Minors, Inability to access app, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

72 Participants Needed

Trial Summary

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.

Will I have to stop taking my current medications?

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

What data supports the idea that Mindfulness Training for Postoperative Pain is an effective treatment?

The available research shows that mindfulness training can be effective for managing postoperative pain. One study found that surgical patients using a mindfulness app reported improved mental health and stress levels, with 88% enjoying the app. Another study showed that mindfulness exercises were linked to higher patient satisfaction after heart surgery. Additionally, mindfulness techniques have been shown to help reduce the risk of chronic pain and opioid misuse after surgery. Compared to other psychological methods, mindfulness is highlighted as a promising non-drug option for pain management. ^{1 2 3 4 5}

What data supports the effectiveness of mindfulness training for postoperative pain?

Research shows that mindfulness training can help reduce anxiety and depression after surgery, improve patient satisfaction, and may help manage chronic pain and reduce the need for opioids. Patients using mindfulness apps reported improved mental health and stress levels, indicating potential benefits for postoperative pain management. ^{1 2 3 4 5}

What safety data exists for mindfulness training for postoperative pain?

The available research indicates that mindfulness-based interventions (MBIs), including app-based mindfulness meditation, are generally well-received and can improve mental health and stress levels in surgical patients. Studies have shown high interest and enjoyment among users, with some evidence supporting their effectiveness in reducing stress and improving well-being. However, adherence to recommended usage levels can be low, and further investigation into barriers to compliance is needed. Overall, mindfulness techniques are considered safe and beneficial for managing perioperative pain and reducing opioid use. ^{1 3 6 7 8}

Is mindfulness training safe for humans?

Mindfulness training, including mindfulness meditation, is generally considered safe for humans. Studies have shown that it can improve mental health and reduce stress levels, with no significant safety concerns reported. ^{1 3 7 9 10}

Is mindfulness training a promising treatment for postoperative pain?

Yes, mindfulness training is a promising treatment for postoperative pain. It can help reduce stress and improve mental health, which are important for managing pain. Many patients find it enjoyable and beneficial, and it can be a useful part of a pain management plan. ^{1 11 12 13 14}

How is mindfulness training different from other treatments for postoperative pain?

Mindfulness training is unique because it is a non-drug approach that focuses on mental exercises to help manage pain and stress, often using a meditation app for convenience. Unlike traditional pain medications, it aims to reduce the need for opioids by improving mental health and stress levels, making it a promising option for those looking to avoid medication. ^{1 11 12 13 14}

What is the purpose of this trial?

This is a randomized control trial investigating the effects of a preoperative mindfulness intervention on postoperative pain, quality of recovery and stress scores in women undergoing minimally invasive hysterectomy. The mindfulness intervention will be delivered via the application Headspace™. The primary outcome will be pain scores measured on postoperative day one. Secondary outcomes will include quality of recovery scores and perceived stress scores measured on postoperative days 1 and 7, amount of opioid consumed, and dose response between number of sessions and/or numbers of minutes of meditation performed on pain and quality of recovery scores. The study team hypothesizes that mindfulness practiced in the form of meditation delivered via an internet application will lead to reduced pain scores on postoperative day 1.

Research Team

Kari M Plewniak, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for adult women fluent in English who are scheduled for minimally invasive hysterectomy and have access to a device (smartphone or computer) that can run the Headspace™ app. It's not open to minors or those unable to use the app or complete surveys in English.

Inclusion Criteria

Fluency in English

Criterion: Have had a minimally invasive hysterectomy.

Access to a device capable of running the Headspace application (smart phone or computer)

Exclusion Criteria

Inability to access Headspace app

Inability to complete surveys in English

Minors

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Mindfulness Training

Participants complete guided meditations via Headspace™ at least 3 sessions per week leading up to surgery

3-4 weeks

Postoperative Monitoring

Participants' pain, quality of recovery, and stress scores are measured on postoperative days 1 and 7

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mindfulness training

Trial Overview The study is testing if mindfulness training through the Headspace™ app before surgery can reduce postoperative pain, improve recovery quality, and lower stress after a minimally invasive hysterectomy. Pain and recovery will be measured on days 1 and 7 post-surgery.

Participant Groups

Group I: Mindfulness training Experimental Treatment 1 Intervention

Completion of guided meditations in the preoperative time period, at least 3 sessions per week, leading up to surgery

Group II: Control Active Control 1 Intervention

Mindfulness training is already approved in European Union, United States for the following indications:

Approved in European Union as Headspace for:

• Stress reduction
• Anxiety management
• Depression management

Approved in United States as Headspace for:

• Stress reduction
• Anxiety management
• Depression management

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Headspace Meditation Limited

Industry Sponsor

Trials

7

Recruited

1,700+

Howard University

Collaborator

Trials

44

Recruited

15,200+

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]

In a study involving cardiac surgical patients, a mindfulness program was implemented pre- and postoperatively, resulting in no patients screening positive for postoperative delirium, suggesting a potential benefit of mindfulness in this context.

Both mindfulness and informational audio groups reported lower anxiety and depression scores post-surgery, along with higher satisfaction ratings regarding their hospital experience, indicating that mindfulness exercises may enhance overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Delirium and Improving Patient Satisfaction With a Perioperative Mindfulness Intervention: A Mixed-Methods Pilot Study. Lisann-Goldman, LR., Pagnini, F., Deiner, SG., et al.[2019]

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]

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]

A systematic review of 15 randomized controlled trials involving 1,199 patients found inconclusive evidence for mindfulness skills training (MST) improving self-reported physical function in chronic pain, highlighting variability in how physical function was measured.

Strong evidence indicated that MST did not lead to improvements in physical function when assessed through performance-based measures, suggesting a need for standardized assessment methods in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. Jackson, W., Zale, EL., Berman, SJ., et al.[2023]

The use of the Headspace® meditation app by anesthesia trainees led to significant reductions in depression scores and increased feelings of personal achievement after 1 and 4 months of use, indicating its potential as a well-being tool.

Despite the positive effects on depression and personal achievement, the app did not significantly reduce burnout symptoms related to emotional exhaustion and depersonalization, suggesting that while mindfulness may help with certain aspects of well-being, it may not fully address all dimensions of burnout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of a smartphone meditation application on anesthesia trainee well-being. Carullo, PC., Ungerman, EA., Metro, DG., et al.[2022]

An 8-week follow-on mindfulness course focusing on awareness of feeling tone was effective in reducing depression, stress, and anxiety among 83 participants, with significant improvements in well-being and mindfulness.

While most participants experienced some unpleasant feelings during the course, none reported harm, indicating that the program is safe, even for those with prior mindfulness experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Next After MBSR/MBCT? An Open Trial of an 8-Week Follow-on Program Exploring Mindfulness of Feeling Tone (vedanā). Williams, JMG., Baer, R., Batchelor, M., et al.[2022]

A mindfulness meditation program using the Headspace app significantly reduced stress, anxiety, and depression among student registered nurse anesthetists (SRNAs) over a 10-day trial, with reductions of 47%, 32%, and 32% respectively.

The study involved 33 SRNAs who completed pre- and post-intervention surveys, demonstrating that mindfulness training can be an effective stress management tool in high-pressure academic settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress Reduction Through Mindfulness Meditation in Student Registered Nurse Anesthetists. Foley, T., Lanzillotta-Rangeley, J.[2021]

Mindfulness-based interventions have been shown to effectively reduce chronic pain intensity and improve overall quality of life, based on a review of 72 systematic reviews and clinical trials.

These interventions can also support individuals with substance use disorders and help maintain smoking abstinence when used alongside standard treatments, indicating their versatility in managing co-occurring health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 2: Clinical Implications for Chronic Pain, Substance Misuse, and Insomnia. Khusid, MA., Vythilingam, M.[2018]

A 60-second personalized mindfulness-based video exercise significantly improved pain intensity, state anxiety, and emotional distress in patients with upper extremity injuries compared to an attention placebo control, although the changes in pain intensity were below the minimal clinically important difference (MCID).

The intervention was found to be feasible and acceptable for patients in busy orthopedic practices, with a dropout rate of 0% and an acceptability score indicating it was well-received by participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a Brief Mindfulness Exercise Improve Outcomes in Upper Extremity Patients? A Randomized Controlled Trial. Westenberg, RF., Zale, EL., Heinhuis, TJ., et al.[2020]

Training for staff in trauma-orthopedic and general surgery departments on postoperative pain control led to improved compliance with the acute pain unit's treatment protocols, as evidenced by a higher number of patients completing prescribed treatments.

While the training did not significantly change patient satisfaction scores or result in large differences in pain levels (less than 0.5 points on the VAS), there was a slight improvement in pain scores on days two and three post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessment of training in the control of acute postoperative pain based on analysis of pretraining and posttraining measures]. Marcos Vidal, JM., Baticón Escudero, PM., Montes Armenteros, A., et al.[2019]

A systematic review of five trials involving various surgical procedures found that cognitive behavioral therapy (CBT) significantly reduces pain intensity and disability in patients experiencing postsurgical pain.

The review highlights the need for further research to optimize the delivery and efficacy of CBT and explore newer psychological approaches for managing postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. Nicholls, JL., Azam, MA., Burns, LC., et al.[2022]

In a study of 85 patients undergoing ambulatory hand surgery, those with higher pain catastrophizing scores used more opioids post-surgery and reported higher pain levels during the first week after the operation.

Conversely, higher mindfulness scores were linked to lower pain levels in the first week, but did not significantly affect opioid use, highlighting the importance of addressing psychological factors in pain management after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Relationship Between Pain-Related Psychological Factors and Postoperative Opioid Use After Ambulatory Hand Surgery. Sacks, HA., Stepan, JG., Wessel, LE., et al.[2020]

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

Reducing Delirium and Improving Patient Satisfaction With a Perioperative Mindfulness Intervention: A Mixed-Methods Pilot Study. [2019]

3. 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]

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

Psychological Methods of Managing Surgical Pain. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Physical functioning and mindfulness skills training in chronic pain: a systematic review. [2023]

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

The impact of a smartphone meditation application on anesthesia trainee well-being. [2022]

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

What Next After MBSR/MBCT? An Open Trial of an 8-Week Follow-on Program Exploring Mindfulness of Feeling Tone (vedanā). [2022]

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

Stress Reduction Through Mindfulness Meditation in Student Registered Nurse Anesthetists. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 2: Clinical Implications for Chronic Pain, Substance Misuse, and Insomnia. [2018]

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

Mindfulness Meditation-Based Pain Relief Employs Different Neural Mechanisms Than Placebo and Sham Mindfulness Meditation-Induced Analgesia. [2022]

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

Does a Brief Mindfulness Exercise Improve Outcomes in Upper Extremity Patients? A Randomized Controlled Trial. [2020]

12. Spain pubmed.ncbi.nlm.nih.gov

[Assessment of training in the control of acute postoperative pain based on analysis of pretraining and posttraining measures]. [2019]

13. New Zealand pubmed.ncbi.nlm.nih.gov

Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. [2022]

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

The Relationship Between Pain-Related Psychological Factors and Postoperative Opioid Use After Ambulatory Hand Surgery. [2020]