Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT05669066
The main purpose of this study is to look at whether meditation techniques can help reduce pain and opioid use after surgery.
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Notify Me18 year–89 year
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02215, United States
Background: The Center for Disease Control identified prescription drug abuse as one of the top 5 current health threats in the US. Orthopedic Surgeons rank among the top 3 prescribers of opioid analgesics. Opioids are commonly used following total knee arthroplasty. Peri- operative protocols have been developed to reduce opioid intake however complications related to opioid analgesics remain problematic resulting in increased morbidity and mortality. There is a pressing need for non-narcotic adjuncts that can minimize /eliminate the use of opioids following elective total knee arthroplasty (TKA). Mind-body techniques including mindful medication (MM) have been demonstrated to reduce pain in acute and chronic disease states.
Purpose: To determine whether mindful meditation, in conjunction with standard analgesic protocols, can impact opioid consumption, pain and function following elective primary TKA.
Methods: a prospective, randomized control trial was conducted in patients aged 18-99 with degenerative joint disease of the knee presenting for primary TKA. Controls received standard perioperative analgesia. In additional to standard analgesia, study patients performed Isha-Krya meditation peri-operatively for 2 weeks followed by 4 weeks post operatively. Outcome measures: opioid consumption, time to discontinue opioids, Pain by Visual Analog Score (VAS), Patient-Reported Outcomes Measurement Information System 10 (PROMIS-10) Global Health Short Form, Knee injury and Osteoarthritis Outcome Score (KOOS)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Adding mindful meditation to pre- and post-operative care for patients who are having a TKA
Other names: meditation, Isha Kriya meditation, Sadhguru meditation
Time frame: 12 months
visual analog scale (VAS) pain score. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain. A higher score (closer to 10mm) is worse pain and a worse outcome.
Time frame: 12 months
Measuring the amount of opioids taken
Time frame: Recorded at time of discharge (up to 4 days post-operatively)
Monitoring how long the patient was in the hospital
Time frame: Recorded at time of discharge (up to 5 days post-operatively)
Recording where the patient was discharged too
Time frame: 90 days post-operatively
Recording whether or not the patient was readmitted to the hospital
Time frame: 90 days post-operatively
PROMIS mental health survey. The measures are generic, rather than disease-specific, and use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. It is a survey of 10 questions which gives a physical health and mental health score. The raw global health mental score (4-20) is converted to a mental health T score (16.2-67.7). The higher the score, the better the health outcome.
Time frame: 90 days post-operatively
PROMIS physical health survey. The measures are generic, rather than disease-specific, and use an "In General" item context as it is intended to globally reflect individuals' assessment of their health. It is a survey of 10 questions which gives a physical health and mental health score. The raw global health physical score (4-20) is converted to a physical health T score (16.2-67.7). The higher the score, the better the health outcome.
Time frame: 90 days post-operatively
KOOS JR survey. The KOOS, JR contains 7 items from the original KOOS survey. Items are coded from 0 to 4, none to extreme respectively. KOOS, JR is scored by summing the raw response (range 0-28) and then converting it to an interval score using the table provided below. The interval score ranges from 0 to 100 where 0 represents total knee disability and 100 represents perfect knee health.
Beth Israel Deaconess Medical Center
Other
The Effect of Mindful Meditation on Opioid Consumption in Patients Who Undergo Primary Total Hip and Knee Replacement
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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