Opioid UseNCT04167852
Mindfulness Meditation and Bariatric Surgery
A study testing Daily text message and Mindfulness intervention in people with Opioid Use and Bariatric Surgery Candidate, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Bariatric Surgery Candidate, Pain, Postoperative
- What is being tested?
- Daily text message and Mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2019to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients > 18 years of age
- 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)
- Ownership of smart phone (iOS or Android operating system) with SMS text messaging capabilities
- Ability to read and understand English
- 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
Who cannot join
- Patients with contraindications to abdominal surgery and/or general anesthesia
- Patients will be screened for PTSD preoperatively. Patients with diagnosable PTSD will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Randomized, Prospective Investigation of a Brief, Daily Mindfulness Intervention for Postoperative Bariatric Patients
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.
Read the 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.
- Conditions
- Opioid Use, Bariatric Surgery Candidate, Pain, Postoperative
- Being tested
- Daily text message, Mindfulness intervention
- Keywords
- Pain, postoperative, meditation, opioid use, bariatric
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily text messageBehavioural
Patients will receive a daily text message stating how many days they have until or since their surgery.
Mindfulness interventionBehavioural
Patients will receive a link to mindfulness meditation intervention for ten minutes.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Subject to receive daily short message service (SMS) text message with a link to a mindfulness intervention. Receives: Behavioral: Daily text message; Behavioral: Mindfulness intervention |
| Text group | Experimental | Subject to receive daily text message but without the link to the mindfulness intervention. Receives: Behavioral: Daily text message |
| Standard of Care group | No intervention | Subject will not receive any text message reminders or the mindfulness meditation intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily post-operative patient reported pain scores
Daily post-operative patient reported pain scores via the validated Numeric Rating Scale (NRS). The higher number indicates more pain.
Measured: 30 days after discharge
Daily post-operative narcotic consumption
Daily post-operative narcotic consumption reported as morphine equivalent dose (MED).
Measured: 30 days after discharge
Secondary outcomes (3)
Patient satisfaction: (HCAHPS) scores
Patient satisfaction as determined by hospital consumer assessment of healthcare providers and services (HCAHPS) scores. HCAHPS is broken down into percentiles and then categorized into "boxes". The higher the percent the more positive the response. The top box is the most positive category, middle box is in-between, and the bottom box is the least positive.
Measured: visit 3 (4 weeks after operation)
Weight loss
Weight loss (expressed by % excessive BMI loss)
Measured: pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months
Bariatric-specific quality of life (BQL)
Bariatric-specific quality of life (BQL). BQL ranges from 14-78 with higher scores representing a better quality of life.
Measured: pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start21 Nov 2019
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Why it stopped: no funding/support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yufei Chen, Cedars-Sinai Medical Center
- Investigators
- Yufei Chen, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167852
- Sponsor's protocol ID
- IIT2019-DILLER-MM
- Status last verified
- Jun 2021
- First submitted
- 31 Oct 2019
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Investigation of a Brief, Daily Mindfulness Intervention for Postoperative Bariatric Patients
- ClinicalTrials.gov ID
- NCT04167852
- Acronym / sponsor ID
- IIT2019-DILLER-MM
- Conditions
- Opioid Use, Bariatric Surgery Candidate, Pain, Postoperative
- Keywords
- Pain, postoperative, meditation, opioid use, bariatric
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no funding/support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 21 Nov 2019 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: Daily text message, Behavioral: Mindfulness interventionSubject to receive daily short message service (SMS) text message with a link to a mindfulness intervention. |
| Text group | Experimental | Behavioral: Daily text messageSubject to receive daily text message but without the link to the mindfulness intervention. |
| Standard of Care group | No intervention | –Subject will not receive any text message reminders or the mindfulness meditation intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients > 18 years of age
- 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)
- Ownership of smart phone (iOS or Android operating system) with SMS text messaging capabilities
- Ability to read and understand English
- 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
Key exclusion criteria (2 listed)
- Patients with contraindications to abdominal surgery and/or general anesthesia
- Patients will be screened for PTSD preoperatively. Patients with diagnosable PTSD will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily text messagePatients will receive a daily text message stating how many days they have until or since their surgery. | Behavioural | Text group, Treatment group |
| Mindfulness interventionPatients will receive a link to mindfulness meditation intervention for ten minutes. | Behavioural | Treatment group |
Primary outcome
Daily post-operative patient reported pain scores
Time frame: 30 days after discharge
Daily post-operative patient reported pain scores via the validated Numeric Rating Scale (NRS). The higher number indicates more pain.
Daily post-operative narcotic consumption
Time frame: 30 days after discharge
Daily post-operative narcotic consumption reported as morphine equivalent dose (MED).
3 secondary outcomes
Patient satisfaction: (HCAHPS) scores
Time frame: visit 3 (4 weeks after operation)
Weight loss
Time frame: pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months
Bariatric-specific quality of life (BQL)
Time frame: pre operation, visit 3 (4 weeks after operation), 3 months, 6 months, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yufei Chen, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily text message and Mindfulness intervention in people with Opioid Use and Bariatric Surgery Candidate, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily post-operative patient reported pain scores (time frame: 30 days after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.