Supportive eHealth Programs for Postoperative Pain

Recruiting at 1 trial location

Overseen By Alicia Patrick, MA, CCRP

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Psychotic disorder, Suicidal ideation, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how two different supportive programs can help women feel better after surgery. One group will engage in mindful movement and breathing exercises, such as yoga (referred to as eHealth Mindful Movement and Breathing - Yoga), while the other will focus on reflecting on life impacts without the active elements of yoga. The trial seeks to identify which program better improves wellbeing after surgery. Women scheduled for abdominal gynecological surgery to remove a potentially cancerous mass are well-suited for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment validation.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the eHealth Mindful Movement and Breathing (eMMB) program is well-liked and may improve wellbeing after surgery. In earlier studies, participants reported feeling less tense, falling asleep more easily, and experiencing less pain with eMMB. They also felt comfortable with the program and would likely recommend it to others.

There is little evidence of serious side effects from eMMB, indicating it is generally well-tolerated. Based on yoga and breathing exercises, eMMB has been studied for safety and is considered safe for most people. Current research supports eMMB as a safe option for those considering joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these eHealth programs for postoperative pain because they offer innovative, non-pharmacological approaches that could complement or even reduce the need for traditional pain medications like opioids. The eHealth Mindful Movement and Breathing (eMMB) treatment is unique because it combines guided yoga and breathing exercises accessible through videos, allowing patients to engage in pain management techniques from the comfort of their home or hospital room. The Life Impacts Reflection (LIR) program offers a supportive framework where patients can reflect on their experiences through brief diary entries, helping them process their postoperative journey. These programs aim to empower patients with techniques that manage pain holistically, potentially leading to quicker and more sustainable recovery without relying solely on medications.

What evidence suggests that this trial's treatments could be effective for improving wellbeing after surgery?

Research has shown that eHealth Mindful Movement and Breathing (eMMB), which participants in this trial may receive, can help reduce pain after surgery. In a previous study, women who used eMMB experienced less pain compared to those who did not use it. Additionally, eMMB has been found to alleviate sleep problems and stress following surgery. By promoting gentle movement and deep breathing, eMMB may aid in recovery. Overall, eMMB could improve well-being after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Stephanie J Sohl, PhD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over 18 who are about to have abdominal surgery for suspected malignant masses in the reproductive system. They must be able to perform daily activities with ease (ECOG ≤1), understand English, and consent to participate. Those with severe psychiatric conditions or suicidal thoughts, or who can't follow study procedures cannot join.

Inclusion Criteria

I am scheduled for surgery to remove a suspected cancerous mass in my abdomen.

Able to understand, read and write English (since the intervention is conducted in English)

I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

I am unable or unwilling to follow the study's procedures.

You have a serious mental health condition like psychosis or current thoughts of harming yourself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Preparation

Participants receive guidance and access to eMMB videos to watch at least once before surgery

1 week

1 virtual session

Postoperative Treatment

Participants engage in eHealth Mindful Movement and Breathing or Life Impact Reflection programs to improve postoperative outcomes

4 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for pain intensity, affective pain, pain interference, and psychological distress symptoms

3 months

Assessments at 2 weeks, 4 weeks, and 3 months postoperatively

What Are the Treatments Tested in This Trial?

Interventions

• eHealth Mindful Movement and Breathing - Yoga
• Life Impacts Reflection

Trial Overview The study compares two supportive programs delivered remotely: eHealth Mindful Movement and Breathing versus Life Impacts Reflection. It aims to determine which program better improves wellbeing after surgery using PROMIS Questionnaires for assessment.

How Is the Trial Designed?

Group I: Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB) Experimental Treatment 2 Interventions

Participants will be given access to 20-minute eMMB videos (either saved as a local files on an iPad or via links to watch on their own devices) with written instructions for eMMB and to watch a video at least once before surgery (videos have the same content, one is taught in a bed and one in a chair). The instructor will call participants before surgery to offer guidance upon request and meet with participants individually via a synchronous videoconference or telephone session, postoperative day 1 (the day after surgery), or as soon as feasible.

Group II: Arm 2 Life Impacts Reflection Group (LIR) Active Control 2 Interventions

The format for interactions with an LIR interventionist, frequency of recommended home practice (brief diary entries), and home assessments will be matched to the eMMB group. LIR will not include active ingredients of eMMB.

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Sudarshan Kriya Yoga (SKY) is a low-risk and cost-effective adjunct treatment for various conditions such as stress, anxiety, PTSD, and depression, supported by clinical observations and studies.

Regular practice of SKY, ideally for 30 minutes daily under skilled guidance, enhances well-being, mood, and stress tolerance, making it a valuable tool for health care providers to recommend to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sudarshan Kriya Yogic breathing in the treatment of stress, anxiety, and depression. Part II--clinical applications and guidelines. Brown, RP., Gerbarg, PL.[2022]

In a study of 2508 yoga class attendees, about 27.8% reported experiencing adverse events, primarily mild musculoskeletal symptoms, indicating that while yoga is generally safe, some participants may face risks, especially those with chronic conditions.

Participants with chronic diseases, poor physical condition, or those who found the class stressful had a higher likelihood of experiencing adverse events, particularly severe ones in elderly individuals and those with chronic musculoskeletal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A large-scale survey of adverse events experienced in yoga classes. Matsushita, T., Oka, T.[2022]

In a randomized clinical trial involving 167 patients after intestinal surgery, nonpharmacological interventions like relaxation and chosen music significantly reduced pain levels compared to a control group, showing a 16-40% decrease in pain on postoperative days 1 and 2.

These interventions can be safely recommended alongside traditional pain medications, as they provide additional pain relief without introducing extra side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relaxation and music reduce pain following intestinal surgery. Good, M., Anderson, GC., Ahn, S., et al.[2022]

Medical yoga combines physical practices with breathing techniques, mindfulness, and meditation, making it effective for both physical and mental health improvements.

Research indicates that medical yoga can help regulate blood glucose levels, alleviate musculoskeletal issues, support cardiovascular health, and enhance psychological well-being by increasing positive emotions and reducing anxiety and depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medical Yoga Therapy. Stephens, I.[2020]

This pilot study aims to evaluate the feasibility and effectiveness of a tailored yoga program for managing acute and subacute postoperative pain in patients aged 40 to 80 undergoing lumbar spine surgeries, with a focus on adherence and compliance as primary outcomes.

The program includes in-person sessions during hospitalization and an 8-week home-based component, assessing secondary outcomes like pain, anxiety, and functional recovery, which could provide a non-pharmacological alternative to traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for Testing Yoga to Reduce Post-Lumbar Spine Surgery Pain: A Methodology Article. Sharma, NK., Aoyagi, K., Crouch Young, MK., et al.[2022]

Postoperative rehabilitation interventions that included breathing exercises significantly reduced the incidence of atelectasis in lung cancer patients, with an odds ratio of 0.35, indicating a strong protective effect against this complication.

Patients who participated in these rehabilitation programs also showed improved lung function, as evidenced by higher forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) scores, suggesting that breathing exercises enhance recovery after lung surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of postoperative rehabilitation interventions that include breathing exercises to prevent pulmonary atelectasis in lung cancer resection patients: a systematic review and meta-analysis. Wang, J., Deng, N., Qi, F., et al.[2023]

In a study involving 60 patients undergoing abdominal surgeries, both neostigmine + buprenorphine and ketamine + buprenorphine provided effective postoperative pain relief, with significant reductions in pain scores over 22 hours.

There was no significant difference in pain relief, vital parameters, or side effects between the two treatment groups, indicating that both combinations are safe and effective options for preemptive epidural analgesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preemptive Epidural Analgesia for Postoperative Pain Relief Revisited: Comparison of Combination of Buprenorphine and Neostigmine with Combination of Buprenorphine and Ketamine in Lower Abdominal Surgeries, A Double-blind Randomized Trial. Choubey, S., Singh, RB.[2022]

In a study of 108 lung cancer patients undergoing surgery, yoga breathing exercises significantly improved dyspnea, exercise capacity, and anxiety compared to usual care, highlighting their efficacy as a supportive therapy.

The combination of yoga breathing exercises with a problem-solving model led to even greater improvements in exercise capability and compliance, suggesting that integrating this model could enhance rehabilitation outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Indicators of Effects of Yoga Breathing Exercises on Patients With Lung Cancer After Surgical Resection: A Randomized Controlled Trial. Lu, HB., Ma, RC., Yin, YY., et al.[2023]

A significant portion of young adults (43.9%) reported experiencing adverse childhood events, which were linked to higher stress levels, highlighting a critical public health concern.

Despite the challenges faced, 12.7% of the young adults practiced yoga for at least 30 minutes a week, with those exposed to adverse events practicing yoga at equal or greater rates than their peers, suggesting yoga could be a beneficial coping strategy for managing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exposure to Adverse Events and Associations with Stress Levels and the Practice of Yoga: Survey Findings from a Population-Based Study of Diverse Emerging Young Adults. Neumark-Sztainer, D., Wall, MM., Choi, J., et al.[2020]

The 'M' Technique, a structured touch method, significantly reduced pain and anxiety in patients undergoing total joint arthroplasty compared to usual care, with the largest predicted decreases observed in the M group.

Patient satisfaction was highest for the M Technique, indicating that the structured touch approach may enhance the overall postoperative experience, even though there was no significant difference in narcotic pain medication use among the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Structured Touch and Guided Imagery for Pain and Anxiety in Elective Joint Replacement Patients--A Randomized Controlled Trial: M-TIJRP. Forward, JB., Greuter, NE., Crisall, SJ., et al.[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]

A systematic review of 94 randomized controlled trials involving 8,430 participants found that yoga is as safe as usual care and exercise, with no significant differences in serious adverse events or dropouts due to adverse events.

While yoga had a higher occurrence of nonserious adverse events compared to psychological or educational interventions, the overall safety profile suggests that it is a viable therapeutic option, highlighting the need for better reporting of safety data in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Cramer, H., Ward, L., Saper, R., et al.[2018]

Supplemental treatments like yoga, acupuncture, and guided imagery can enhance patient recovery and satisfaction, leading to financial benefits for hospitals.

Using guided imagery during procedures can reduce sedation costs, while overall patient satisfaction improvements can increase hospital revenue and decrease patient length of stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The low risk and high return of integrative health services. Russo, R., Diener, I., Stitcher, M.[2015]

Mindfulness-based interventions (MBIs) have been shown to effectively relieve pain and improve physical functioning in postoperative patients, while isometric exercise training (IET) specifically enhances physical functioning.

Although both MBIs and IET offer numerous benefits, including improved quality of life and reduced opioid use, there is currently no research on their combined effects, which could potentially lead to even greater improvements in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving Postoperative Care Through Mindfulness-Based and Isometric Exercise Training Interventions: Systematic Review. Reynolds, A., Hamidian Jahromi, A.[2022]

Relaxation techniques and music have been found to effectively reduce emotional and observed pain in postoperative patients, although they are less effective in decreasing sensory pain or the need for opioids.

The review highlights significant variability in study designs and methodologies, suggesting that more rigorous randomized controlled trials are needed to determine the most effective types of relaxation and music interventions for pain management in postoperative settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of relaxation and music on postoperative pain: a review. Good, M.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9883595/

A randomized pilot of eHealth Mindful Movement and ... This pilot study of eMMB supported feasibility and improvements in pain intensity that warrant a future efficacy study.

2. tandfonline.com tandfonline.com/doi/abs/10.1080/07347332.2022.2101908

A randomized pilot of eHealth mindful movement and ... Average reductions in the primary outcome of pain intensity were larger in the eMMB group than AC group (Week 2 d = −0.38; Week 4 d = −0.46).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10794552/

Qualitative Results from a Randomized Pilot Study of ... Improved management of pain and co-morbid symptoms (sleep disturbances, psychological distress) among women undergoing surgery for suspected gynecologic ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pon.5146

Iterative adaptation process for eHealth Mindful Movement ... Practicing yoga may reduce pain and support usual care goals of encouraging mobility and deep breathing during the acute perioperative timeframe ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03379376

NCT03379376 | EHealth Mindful Movement and Breathing ... Study Overview. This trial determines how well eHealth mindful movement and breathing works to improve outcomes in participants undergoing gynecologic surgery.

6. withpower.com withpower.com/trial/phase-3-dyssomnias-2023-0f741

Supportive eHealth Programs for Postoperative Pain What safety data exists for eHealth programs like yoga and breathing exercises? The safety of yoga and related practices has been evaluated in several studies.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37462260/

Qualitative results from a randomized pilot study of eHealth ... Positive impacts of practicing eMMB included that it relieved tension, facilitated falling asleep, and decreased pain.

8. researchgate.net researchgate.net/publication/333908110_Iterative_adaptation_process_for_eHealth_Mindful_Movement_and_Breathing_to_improve_gynecologic_cancer_surgery_outcomes

Iterative adaptation process for eHealth Mindful Movement ... Findings: Participants reported overall high acceptability such that all would recommend the study to others. Positive impacts of practicing eMMB included that ...