Mindfulness Training for Postoperative Pain

Recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness training through the Headspace app might reduce pain and improve recovery after minimally invasive hysterectomy. By practicing meditation before surgery, the researchers aim to determine if patients experience less pain and stress, and an overall better recovery. Women fluent in English with access to a smartphone or computer for the Headspace app may be suitable candidates if scheduled for this type of surgery. As an unphased trial, this study offers a unique opportunity to contribute to understanding the benefits of mindfulness in surgical recovery.

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 prior data suggests that this mindfulness training is safe for postoperative pain management?

Research has shown that mindfulness training, such as meditation, is generally safe for most people. One study found that mindfulness can improve mental health and reduce stress without major safety concerns, meaning participants did not report serious problems while practicing mindfulness.

Other studies have found that people who practiced mindfulness experienced less pain after surgery, suggesting that mindfulness can aid recovery. The main point is that mindfulness is well-tolerated and has not shown harmful side effects in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard postoperative pain treatments that often rely on medications like opioids or NSAIDs, mindfulness training offers a drug-free alternative that focuses on mental techniques to manage pain. This approach involves guided meditations practiced regularly before surgery, which can help patients develop skills to better handle pain and stress. Researchers are excited about this method because it empowers patients to play an active role in their pain management, potentially reducing reliance on medications and minimizing side effects.

What evidence suggests that mindfulness training is effective for postoperative pain?

Research has shown that practicing mindfulness, such as meditation, can help reduce pain after surgery. One review found that meditation eased pain and anxiety following surgery. Another study found that greater mindfulness before surgery linked to better pain relief afterwards. Programs like Mindfulness-Based Stress Reduction (MBSR) have reduced pain more effectively than standard care. In this trial, participants in the mindfulness training arm will complete guided meditations in the preoperative period. Additionally, mindfulness training might decrease the need for pain medications, such as opioids. These findings suggest that mindfulness meditation could effectively manage pain after surgery. ^{2 3 6 7 8}

Who Is on the Research Team?

Kari M Plewniak, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

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