Rotator Cuff Tears
Conditions
Keywords
Shoulder Arthroscopy, head space, mindfulness, Subacromial bursitis, biceps tenodesis
Brief summary
The objective of this study is to examine the effectiveness of mindfulness/meditation using the Headspace App on post-operative pain and opioid consumption in patients after arthroscopic rotator cuff repairs, biceps tenodesis, and Mumford procedures.
Detailed description
The purpose of this study is to examine the effectiveness of mindfulness/meditation on post-operative pain and opioid consumption. Patients will be randomized into one of two standardized groups after shoulder arthroscopy: Control group (CON) and mindfulness/meditation group (MM). All participants will be consented and enrolled into the study before surgery. Both groups will receive the same standardized method of post-operative pain medication for post-operative pain relief. Participants in the MM group will utilize a Headspace application on their smart phone meditate twice a day while the control group will not perform any meditation or mindfulness. Patient reported outcomes will be collected at regular intervals. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis and/or Mumford procedure. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 6 months which will include 3 standard of care post-operative visits and electronic surveys to track patient reported outcome.
Interventions
OTHERIn addition to standard post-op medication patient will have access to the head space meditation application.
Patients will receive access to head space meditation application in addition to standard pain medication post surgery.
OTHERPatients will take standard post-op pain medication
Standard post-op pain medication
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years and older * Status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or Mumford Procedure
Exclusion criteria
* Less than 18 years old * Patients undergoing a simultaneous arthroscopic procedure that is not in the inclusion criteria. * History of shoulder osteoarthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual analog scale | 2 weeks post-op | single-item measure of pain and consists of a 100 millimeter (mm) horizontal line with the labels No Pain at the leftmost portion and Worst Pain at the rightmost portion of the line |
| number of opioid pills | 2 weeks post-op | number of pills taken at each time point |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| compliance of the intervention in the MM groups which will be tracked via the Headspace application. | 2 weeks post-op | used to detect the association between using the Headspace application and the amount of post-operative pain |
| Patient reported out comes :Single Assessment Numeric Evaluation (SANE) | 2 weeks post-op | composed of a single question, would be a valid and responsive instrument to provide a global assessment of patients shoulder function on a scale of 1-100 |
| Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) | 2 weeks post-op. | 12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health. |
Countries
United States
Outcome results
None listed