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

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.

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 Supportive eHealth Programs for Postoperative Pain is an effective treatment?

The available research shows that Supportive eHealth Programs, like yoga and breathing exercises, can help manage pain and anxiety after surgery. One study is testing a yoga program for people who had spine surgery, delivered both in-person and online, to see if it helps with pain and anxiety. Another study highlights that mind-body programs can improve sleep and reduce anxiety and pain for surgical patients. Additionally, using yoga and breathing exercises has been shown to help lung cancer patients recover better after surgery. These findings suggest that such programs can be effective in improving recovery and reducing pain after surgery. ^{1 2 3 4 5}

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. A systematic review and meta-analysis of randomized controlled trials found no significant differences in serious or nonserious adverse events when comparing yoga to usual care or exercise. However, more nonserious adverse events were reported compared to psychological or educational interventions. Additionally, a large-scale survey in Japan noted the occurrence of yoga-related adverse events, though specific frequencies and characteristics were not detailed. Overall, yoga is considered a low-risk intervention with potential benefits for stress, anxiety, and other conditions, especially when practiced under proper guidance. ^{6 7 8 9 10}

Is the treatment in the trial 'Supportive eHealth Programs for Postoperative Pain' a promising treatment?

Yes, supportive eHealth programs for postoperative pain are promising because they can help patients manage pain better, improve their ability to move and function, and reduce anxiety after surgery. These programs can include techniques like mindfulness, relaxation, and music, which have been shown to effectively reduce pain and improve recovery. ^{11 12 13 14 15}

Research Team

Stephanie J Sohl, PhD

Principal Investigator

Wake Forest Baptist Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States 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. [2023]

2. England 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. [2023]

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

Protocol for Testing Yoga to Reduce Post-Lumbar Spine Surgery Pain: A Methodology Article. [2022]

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

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

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

The low risk and high return of integrative health services. [2015]

6. United States 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. [2020]

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

Medical Yoga Therapy. [2020]

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

The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]

10. England pubmed.ncbi.nlm.nih.gov

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

11. India 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. [2022]

12. Canada pubmed.ncbi.nlm.nih.gov

Improving Postoperative Care Through Mindfulness-Based and Isometric Exercise Training Interventions: Systematic Review. [2022]

13. United States 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. [2022]

14. England pubmed.ncbi.nlm.nih.gov

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

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

Relaxation and music reduce pain following intestinal surgery. [2022]