Clinical trial NCT04167852: Mindfulness Meditation and Bariatric Surgery
Official title: A Randomized, Prospective Investigation of a Brief, Daily Mindfulness Intervention for Postoperative Bariatric Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Opioid Use
Bariatric Surgery Candidate
Pain, Postoperative
Keywords: Pain
postoperative
meditation
opioid use
bariatric
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-11-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study represents a 3-arm, randomized controlled trial to investigate the impact of a validated 10-minute mindfulness intervention delivered via mobile technology on postoperative bariatric patients. The investigators hypothesize that participation in a brief, daily mindfulness intervention will improve outcomes in bariatric patients and use of mobile technology will facilitate patient compliance.

Detailed description: Background:

Bariatric patients represent a unique surgical population and present significant challenges regarding safe and effective postoperative pain control. Recent analyses demonstrate that rates of prolonged opioid use in the initial postoperative year is higher amongst bariatric patients when compared to the general surgery population in both opiate-naïve and chronic opioid users. While bariatric surgery is an important treatment for obesity and improves many co-morbid conditions including musculoskeletal and nonspecific pain, it is interesting to note this has not translated to a reduction in use of opioid analgesics. These findings are likely the result of unique psychosocial and physiologic factors that affect obese patients. The co-occurrence of mood disorders such as anxiety and depression is well established within the bariatric and psychiatric literature. Depression, psychological vulnerability, and stress are closely associated with persistent postoperative pain, and the use of preoperative benzodiazepines and selective serotonin reuptake inhibitors (SSRI) directly correlate to prolonged postoperative narcotic consumption. In addition, several studies indicate higher rates of substance abuse in patients following bariatric surgery thus highlighting a potential predisposition for addictive behavior. Postoperative pain control following bariatric surgery is further complicated by the general avoidance of non-steroidal anti-inflammatory agents (NSAIDs) and altered drug absorption following roux-en-y gastric bypass (RYGB).

Mindfulness meditation represents an important and validated means of non-pharmacologic pain control. While different types of meditation exist, the cornerstone of a mindfulness practice involves a heightened awareness and non-judgmental acceptance of the present moment. While there have been several proposed theories regarding its mechanism of action, neuroimaging studies demonstrate altered sensory processing and cognitive control mechanisms when such techniques are employed during experimentally-induced pain. The most well studied mindfulness intervention is mindfulness-based stress reduction (MBSR). MBSR is a 6-8-week program that involves weekly group-training sessions in mindfulness meditation. Randomized-controlled trials demonstrate improved quality of life, reduced stress, improved depressive symptoms, and reduced pain scores in patients with chronic illness who participate in an MBSR program. Importantly, symptom improvement was immediate and durable with effects lasting up to one year without the need for continued practice. More recent studies suggest that single, brief mindfulness interventions may deliver effective pain relief as well. A randomized-controlled trial published in 2017 demonstrated clinically significant reductions in pain, comparable to 5 mg of oxycodone, after 15-minutes of guided mindfulness meditation in patients experiencing an acute pain crisis.

In spite of the overwhelming evidence demonstrating mindfulness meditation as an effective pain management strategy in both acute and chronic pain syndromes, it remains underutilized in the clinical setting. The investigators have identified two principle barriers to implementation of mindfulness interventions in surgical patients: 1) limited access to validated mindfulness interventions and 2) a prohibitive mode of delivery to patients. While more rigorous studies and systematic reviews have produced validated mindfulness interventions, delivery of interventions depended on lengthy, classroom instruction or use of inpatient social workers and nurses. Conversely, the health and wellness community has taken advantage of the ubiquity of mobile phones to provide the general public a multitude of consumer health apps geared towards mindfulness yet few of these are driven by evidence-based medicine or report having been tested for efficacy. While mobile technology offers a unique platform to cost-effectively engage, educate, and intervene in specific patient populations, input from clinicians and researchers is imperative. For this reason, the investigators propose investigation of a validated mindfulness intervention adapted for delivery via a mobile platform in patients undergoing bariatric surgery.

Rationale:

Chronic opioid use represents a national health crisis, fueled by the over-prescription of narcotic pain medications for surgical procedures. In spite of the opioid epidemic, opiate analgesics continue to represent a primary modality for acute postoperative pain management with more than 80% of patients receiving opioids even after low risk surgery. Unfortunately, both poorly-controlled postoperative pain and short-term opioid use are associated with the development of chronic postsurgical pain and increases one's risk of subsequent opioid dependence. Surgical patients therefore represent an at-risk population for impaired health-related quality of life (HRQoL) and opioid-related adverse events.

Patients undergoing bariatric surgery pose a unique challenge to healthcare providers with regards to opiate-sparing pain control. Co-existing mood disorders are common amongst bariatric patients which may predispose them to substance abuse and dependence. Altered postoperative anatomy and physiology limits administration of non-steroidal anti-inflammatory agents (NSAIDs) and impairs drug absorption. In an effort to address the growing opioid epidemic, the Joint Commission recently revised its pain standards adding an emphasis on inclusion of non-narcotic and non-pharmacologic adjuncts to current hospital-based pain management strategies. While there has been significant effort in identifying effective narcotic-sparing pain regimens for bariatric patients, all rely on pharmacologic means of pain control, impart a mild to moderate economic burden, and fail to address the myriad of psychosocial factors that influence postoperative pain and chronic opioid use in bariatric patients. As such, there exists both a need and an opportunity to further expand our current armamentarium of pain control by investigating non-pharmacologic modalities.

Eligibility criteria: Inclusion Criteria:

1. Patients \> 18 years of age
2. BMI \> 40 or a BMI \> 35 with the presence of at least 1 comorbidity (hypertension, diabetes, sleep apnea syndrome, coronary artery disease, dyslipidemia, osteoarthritis, secondary infertility in females)
3. Ownership of smart phone (iOS or Android operating system) with SMS text messaging capabilities
4. Ability to read and understand English
5. Ability to understand the purposes and risk of the study and willingly give standard written informed consent for treatment established by Cedars Sinai Medical Center

Exclusion Criteria:

1. Patients with contraindications to abdominal surgery and/or general anesthesia
2. Patients will be screened for PTSD preoperatively. Patients with diagnosable PTSD will be excluded from the study.

Primary outcomes:
measure: Daily post-operative patient reported pain scores
timeFrame: 30 days after discharge
measure: Daily post-operative narcotic consumption
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Patient satisfaction: (HCAHPS) scores
timeFrame: visit 3 (4 weeks after operation)
measure: Weight loss
timeFrame: pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months
measure: Bariatric-specific quality of life (BQL)
timeFrame: pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Yufei Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: