Supportive eHealth Programs for Postoperative Pain
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Wake Forest University Health Sciences
Disqualifiers: Psychotic disorder, Suicidal ideation, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
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.
12345What 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.
678910Is 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.
1112131415Eligibility 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.
+2 more
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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB)Experimental Treatment2 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 Control2 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, NC
Atrium Health - Levine Cancer InstituteCharlotte, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
National Cancer Institute (NCI)Collaborator
References
Clinical Indicators of Effects of Yoga Breathing Exercises on Patients With Lung Cancer After Surgical Resection: A Randomized Controlled Trial. [2023]Cancer itself and surgery pose a heavy burden on adults with lung cancer. Yoga breathing exercises have been proposed as a form of pulmonary rehabilitation exercises to improve these patients' perioperative outcomes.
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]The main aim of this systematic review was to determine the effectiveness of postoperative rehabilitation interventions that include breathing exercises as a component to prevent atelectasis in lung cancer resection patients.
Protocol for Testing Yoga to Reduce Post-Lumbar Spine Surgery Pain: A Methodology Article. [2022]Currently, acute postoperative pain during hospitalization is primarily managed by medications, and patients must adhere to restrictive postoperative precautions for 3 months following lumbar spine surgeries. Yoga can be an alternative approach to assist in acute and subacute postoperative pain management, anxiety, and return to function. The purpose of the present work was to develop and test the feasibility and explore the effectiveness of a tailored yoga program, delivered in-person during the hospital stay and electronically after hospital discharge, as a potential new avenue for postoperative care. This pilot study will use a crossover randomized controlled design. Individuals aged between 40 and 80 years who are scheduled for lumbar laminectomy and/or fusion, and who have not practiced regular yoga within the past 6 months at the time of enrollment, will be recruited and randomized to either a tailored yoga program (intervention group) or usual care (control group) during the hospital stay (phase one). Bearing in mind postoperative precautions, all subjects will be instructed to perform a home-based tailored yoga program delivered electronically via YouTube links for 8 weeks post-hospital discharge (phase two). The primary outcome measures assessing feasibility are adherence/compliance. Secondary outcome measures include pain, anxiety, function, sleep, perceived stress, and pain-catastrophizing behavior. Length of hospital stay and pain medication use, gait distance, and overall physical activity during hospitalization will also be collected. Finally, a qualitative interview will be obtained after completion of the hospital and home-based programs. This study will determine the feasibility of a tailored yoga program for acute and subacute postoperative lumbar spine surgery pain, anxiety, and functional outcomes.
Preparing for successful surgery: an implementation study. [2022]To evaluate the implementation of a mind-body program for surgical patients in a community hospital, assessing patient participation, patient perception, and program impact on anxiety, pain, and quality of sleep during the perioperative period.
The low risk and high return of integrative health services. [2015]Supplemental treatments and practices such as yoga, acupuncture, guided imagery, and meditation can benefit not only patients in their recovery but also hospitals and health systems financially and operationally. Benefits include: > Savings in sedation costs for patients who use guided imagery during procedures > Increased revenue due to measurably increased patient satisfaction > Decreased length of stay.
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]Objectives: This study examines the prevalence of exposure to adverse events and associations with stress levels among a diverse population-based sample of young people. The study further explores whether these vulnerable populations, who have the potential to benefit from the mind-body practice of yoga, engage in a regular yoga practice. Design: EAT 2018 (Eating and Activity over Time) is a population-based study in which survey data were collected from 1568 ethnically/racially diverse (81.2% nonwhite) emerging young adults (mean age: 22.0 ± 2.0 years). Results: Exposure to adverse events was highly prevalent. For example, 43.9% reported at least one adverse childhood experience (ACE) (e.g., physical, emotional, or sexual abuse before age 18), whereas 40.1% reported experiencing discrimination. Exposure to adverse events was associated with higher stress levels. Practicing yoga at least 30 min/week was reported by 12.7% of the population, with variation across sociodemographic characteristics. Young adults exposed to adverse events were either more or similarly likely to practice yoga than young adults not reporting adverse events. Conclusions: The high prevalence of exposure to adverse events and associations with higher levels of stress points to a need for public health interventions. Thus, it was promising to find that young people exposed to adverse events, who may have greater emotional burdens, practice yoga at equal or greater proportions to those without these exposures. Given the potential benefits of yoga for populations living with high stress, it is important to develop further outreach efforts and provide accessible, acceptable, and affordable opportunities for practicing yoga.
Sudarshan Kriya Yogic breathing in the treatment of stress, anxiety, and depression. Part II--clinical applications and guidelines. [2022]Yogic breathing is a unique method for balancing the autonomic nervous system and influencing psychologic and stress-related disorders. Part I of this series presented a neurophysiologic theory of the effects of Sudarshan Kriya Yoga (SKY). Part II will review clinical studies, our own clinical observations, and guidelines for the safe and effective use of yoga breath techniques in a wide range of clinical conditions. Although more clinical studies are needed to document the benefits of programs that combine pranayama (yogic breathing) asanas (yoga postures), and meditation, there is sufficient evidence to consider Sudarshan Kriya Yoga to be a beneficial, low-risk, low-cost adjunct to the treatment of stress, anxiety, post-traumatic stress disorder (PTSD), depression, stress-related medical illnesses, substance abuse, and rehabilitation of criminal offenders. SKY has been used as a public health intervention to alleviate PTSD in survivors of mass disasters. Yoga techniques enhance well-being, mood, attention, mental focus, and stress tolerance. Proper training by a skilled teacher and a 30-minute practice every day will maximize the benefits. Health care providers play a crucial role in encouraging patients to maintain their yoga practices.
Medical Yoga Therapy. [2020]Medical yoga is defined as the use of yoga practices for the prevention and treatment of medical conditions. Beyond the physical elements of yoga, which are important and effective for strengthening the body, medical yoga also incorporates appropriate breathing techniques, mindfulness, and meditation in order to achieve the maximum benefits. Multiple studies have shown that yoga can positively impact the body in many ways, including helping to regulate blood glucose levels, improve musculoskeletal ailments and keeping the cardiovascular system in tune. It also has been shown to have important psychological benefits, as the practice of yoga can help to increase mental energy and positive feelings, and decrease negative feelings of aggressiveness, depression and anxiety.
The Safety of Yoga: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2018]As yoga has gained popularity as a therapeutic intervention, its safety has been questioned in the lay press. Thus, this review aimed to systematically assess and meta-analyze the frequency of adverse events in randomized controlled trials of yoga. MEDLINE/PubMed, Scopus, the Cochrane Library, and IndMED were screened through February 2014. Of 301 identified randomized controlled trials of yoga, 94 (1975-2014; total of 8,430 participants) reported on adverse events. Life-threatening, disabling adverse events or those requiring intensive treatment were defined as serious and all other events as nonserious. No differences in the frequency of intervention-related, nonserious, or serious adverse events and of dropouts due to adverse events were found when comparing yoga with usual care or exercise. Compared with psychological or educational interventions (e.g., health education), more intervention-related adverse events (odds ratio = 4.21, 95% confidence interval: 1.01, 17.67; P = 0.05) and more nonserious adverse events (odds ratio = 7.30, 95% confidence interval: 1.91, 27.92; P
A large-scale survey of adverse events experienced in yoga classes. [2022]Yoga is a representative mind-body therapy of complementary and alternative medicine. In Japan, yoga is practiced widely to promote health, but yoga-associated adverse events have also been reported. To date, the frequencies and characteristics of yoga-related adverse events have not been elucidated. This study was conducted to elucidate the frequencies and characteristics of adverse events of yoga performed in classes and the risk factors of such events.
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]Postoperative pain relief provides subjective comfort to patient in addition to blunting of autonomic and somatic reflex responses to pain, subsequently enhancing restoration of function by allowing the patient to breathe, cough, and move easily.
Improving Postoperative Care Through Mindfulness-Based and Isometric Exercise Training Interventions: Systematic Review. [2022]Mindfulness-based cognitive therapy and isometric exercise training (IET) interventions are relatively new approaches to maintain physical functioning, alleviate pain, prevent joint stiffness and muscular atrophy, and positively influence other postoperative care outcomes.
Effect of Structured Touch and Guided Imagery for Pain and Anxiety in Elective Joint Replacement Patients--A Randomized Controlled Trial: M-TIJRP. [2022]Postoperative management of pain after total joint arthroplasty remains a challenge despite advancements in analgesics. Evidence shows that complementary modalities with mind-body and tactile-based approaches are valid and effective adjuncts to reduce pain and anxiety postoperatively.
Effects of relaxation and music on postoperative pain: a review. [2019]Postoperative patients differ in their response to pain and opioids. It is therefore important that nurses offer other options as adjuvants to medication. Relaxation and music may reduce pain by interrupting the postoperative cycle of pain, muscle tension and sympathetic activity. This review summarizes and critiques studies on the effectiveness of relaxation and music use during postoperative pain. Relaxation and music were effective in reducing affective and observed pain in the majority of studies, but they were less often effective in reducing sensory pain or opioid intake. However, the between-study differences in surgical procedures, experimental techniques, activities during testing, measurement of pain, and amount of practice make comparisons difficult. Furthermore, within studies, the problems of inadequate sample size, lack of random assignment, no assurance of pretest equivalence, delayed post-test administration and no control for opiates at the time of testing reduces the validity of the studies' conclusions. Randomized controlled studies of the types of relaxation and music that are most helpful to postoperative patients should be explored in various contexts.
Relaxation and music reduce pain following intestinal surgery. [2022]Three nonpharmacological nursing interventions, relaxation, chosen music, and their combination, were tested for pain relief following intestinal (INT) surgery in a randomized clinical trial. The 167 patients were randomly assigned to one of three intervention groups or control and were tested during ambulation and rest on postoperative days 1 and 2. Pain sensation and distress were measured with visual analog scales (VAS). Multivariate analysis of covariance showed significantly less post-test pain in the intervention groups than in the control group on both days after rest and at three of six ambulation post-tests (p = .024-.001), resulting in 16-40% less pain. Mixed effects after ambulation were due to the large variation in pain and difficulty relaxing while returning to bed; but post hoc explorations showed effects for those with high and low pain. These interventions are recommended along with analgesics for greater postoperative relief without additional side effects.