Feasibility of a Meditation Program PerioperativelyNCT03198039
Guided Meditation as an Adjunct to Enhance Postoperative Recovery
A study testing Meditation in people with Feasibility of a Meditation Program Perioperatively, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feasibility of a Meditation Program Perioperatively
- What is being tested?
- Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2017to 30 Apr 2020
- 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
- 18 years of age or older
- Undergoing any of the following types of cardiac surgery: CABG with or without valve surgery (aortic and/or mitral); isolated valve surgery; isolated aortic surgery
- Surgery scheduled for at least 14 days after enrollment
Who cannot join
- Urgent and/or emergent surgery
- Non-English speaking
- Cognitive impairment as defined by total MoCA score < 10
- Baseline DASS-21 depression score >10
- Pre-existing history of psychiatric illness as documented in the medical record or divulged in history taking in pre-enrollment patient interview, such as anxiety, depression, or bipolar disorder
- History of cerebrovascular accident or recent history (< 3 months) of seizures
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- History of dementia, Parkinson's disease, Alzheimer's disease, or other forms of cognitive decline
- Current use of cognition enhancing drugs
- Current management for chronic pain
- Currently enrolled in another interventional study that could impact the primary outcome, as determined by the PI
- Educational attainment below high school level or equivalent
- Significant visual impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Guided Meditation as an Adjunct to Enhance Postoperative Recovery: A Feasibility Study
The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.
Read the detailed description
This is a prospective, randomized, controlled study involving 30 adult patients undergoing cardiac surgery. Investigators will test the feasibility of implementing a meditation program in the perioperative period. Patients will be randomized to one of three groups: those who complete Isha Kriya (IK) meditation before and after surgery, those who complete postoperative IK meditation only, and those who receive the standard of care with no meditation intervention. In addition to testing feasibility, the investigators will explore whether a meditation program can affect recovery after surgery. Patients enrolled will be followed postoperatively for up to one month to assess their cognitive function, pain, and sleep. Blood will also be collected for analysis of biomarkers of inflammation.
- Being tested
- Meditation
- Keywords
- Meditation, Cognitive Dysfunction, Postoperative Period, Cardiac Surgery
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeditationBehavioural
Isha Kriya (IK) meditation approximately 12 minutes, twice a day
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Meditation twice daily for at least two weeks prior to surgery and for four weeks after surgery Receives: Behavioral: Meditation |
| Group 2 | Experimental | Meditation twice daily for four weeks after surgery Receives: Behavioral: Meditation |
| Group 3 | No intervention | Control group - will undergo surgery and subsequent hospital stay according to the current standard of care, which does not include meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to implementing a meditation program in the perioperative period
In this descriptive, feasibility study, evaluation of feasibility will include adherence to meditation intervention (total number of sessions completed).
Measured: Baseline through 1 month post surgery
Secondary outcomes (6)
Cognitive function - MoCA
The Montreal Cognitive Assessment (MoCA) will be administered at baseline and hospital discharge. This is a validated test that measures cognitive impairment.
Measured: Baseline and hospital discharge (approximately 5 days)
Pain scores
Postoperative pain will be assessed with a standard 11-point scale. Pain scores will be obtained by asking the subject.
Measured: Postoperative Day 1 through hospital discharge (approximately 5 days)
Total Opioid Consumption
The total opioid dosage received in the intraoperative period and the first 48 hours postoperatively will be abstracted from the medical record.
Measured: Intraoperatively through 48 hours postoperatively
Changes in Sleep - PSQI
Changes in sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI) which measures quality and patterns of sleep during the past month. This will be completed at baseline and 1 month postoperatively.
Measured: Baseline and 1 month postoperatively
Changes in Sleep - PROMIS
Changes in sleep will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance and Sleep Related Impairment questionnaires. The PROMIS sleep questionnaires assess self-reported perceptions of sleep quality and sleep impairment and will be completed weekly from baseline through 1 month postoperatively.
Measured: Baseline through 1 month postoperatively
Biomarkers of inflammation
Blood will be collected at baseline and on postoperative Day 2 to investigate whether the use of a meditation regimen results in a reduction in inflammation and stress secondary to surgery. Subjects randomized to meditation before surgery will also have blood collected preoperatively. Specimens will be frozen for analysis at a later date.
Measured: Baseline, preoperatively, and Day 2 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start28 Nov 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Feasibility of a Meditation Program PerioperativelyStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
- Investigators
- Balachundhar Subramaniam, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03198039
- Sponsor's protocol ID
- 2017P000239
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2017
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Packiasabapathy S, Susheela AT, Mueller A, Patxot M, Gasangwa DV, O'Gara B, Shaefi S, Marcantonio ER, Yeh GY, Subramaniam B. Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial. Trials. 2019 Jan 11;20(1):39. doi: 10.1186/s13063-018-3103-8.
PubMed 30635064
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Meditation as an Adjunct to Enhance Postoperative Recovery: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03198039
- Acronym / sponsor ID
- 2017P000239
- Keywords
- Meditation, Cognitive Dysfunction, Postoperative Period, Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 23 Jun 2017 (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.
The primary purpose of this trial is to test the feasibility of implementing a meditation program in the perioperative period.
Detailed description
This is a prospective, randomized, controlled study involving 30 adult patients undergoing cardiac surgery. Investigators will test the feasibility of implementing a meditation program in the perioperative period. Patients will be randomized to one of three groups: those who complete Isha Kriya (IK) meditation before and after surgery, those who complete postoperative IK meditation only, and those who receive the standard of care with no meditation intervention. In addition to testing feasibility, the investigators will explore whether a meditation program can affect recovery after surgery. Patients enrolled will be followed postoperatively for up to one month to assess their cognitive function, pain, and sleep. Blood will also be collected for analysis of biomarkers of inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Behavioral: MeditationMeditation twice daily for at least two weeks prior to surgery and for four weeks after surgery |
| Group 2 | Experimental | Behavioral: MeditationMeditation twice daily for four weeks after surgery |
| Group 3 | No intervention | –Control group - will undergo surgery and subsequent hospital stay according to the current standard of care, which does not include meditation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Undergoing any of the following types of cardiac surgery: CABG with or without valve surgery (aortic and/or mitral); isolated valve surgery; isolated aortic surgery
- Surgery scheduled for at least 14 days after enrollment
Key exclusion criteria (12 listed)
- Urgent and/or emergent surgery
- Non-English speaking
- Cognitive impairment as defined by total MoCA score < 10
- Baseline DASS-21 depression score >10
- Pre-existing history of psychiatric illness as documented in the medical record or divulged in history taking in pre-enrollment patient interview, such as anxiety, depression, or bipolar disorder
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 |
|---|---|---|
| MeditationIsha Kriya (IK) meditation approximately 12 minutes, twice a day | Behavioural | Group 1, Group 2 |
Primary outcome
Adherence to implementing a meditation program in the perioperative period
Time frame: Baseline through 1 month post surgery
In this descriptive, feasibility study, evaluation of feasibility will include adherence to meditation intervention (total number of sessions completed).
6 secondary outcomes
Cognitive function - MoCA
Time frame: Baseline and hospital discharge (approximately 5 days)
Pain scores
Time frame: Postoperative Day 1 through hospital discharge (approximately 5 days)
Total Opioid Consumption
Time frame: Intraoperatively through 48 hours postoperatively
Changes in Sleep - PSQI
Time frame: Baseline and 1 month postoperatively
Changes in Sleep - PROMIS
Time frame: Baseline through 1 month postoperatively
Biomarkers of inflammation
Time frame: Baseline, preoperatively, and Day 2 postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Derived from this study: PubMed 30635064Packiasabapathy S, Susheela AT, Mueller A, Patxot M, Gasangwa DV, O'Gara B, Shaefi S, Marcantonio ER, Yeh GY, Subramaniam B. Guided meditation as an adjunct to enhance postoperative recovery after cardiac surgery: study protocol for a prospective randomized controlled feasibility trial. Trials. 2019 Jan 11;20(1):39. doi: 10.1186/s13063-018-3103-8.
- Individual participant dataSharing planned: Undecided
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.
Balachundhar Subramaniam, MD, MPH principal investigator
Beth Israel Deaconess 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 Meditation in people with Feasibility of a Meditation Program Perioperatively, run by Beth Israel Deaconess 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 3 inclusion and 12 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: finished, as of the sponsor's last update on 4 Jun 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adherence to implementing a meditation program in the perioperative period (time frame: Baseline through 1 month post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03198039, which also lists 1 linked publication.
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 4 Jun 2024.