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Poor patient compliance
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control (CON) | Active Comparator | will receive the usual standard of care post-operative pain pills for the involved shoulder (Control Group) |
|
| Mindfulness/Meditation (MM) | Experimental | will receive the usual standard of care post-operative pain pills for the involved shoulder with the addition of access to the Headspace application for mindfulness/meditation (Mindfulness/Meditation Group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In addition to standard post-op medication patient will have access to the head space meditation application. | Other | Patients will receive access to head space meditation application in addition to standard pain medication post surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| visual analog scale | 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 | 2 weeks post-op |
| visual analog scale | 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 | 6 weeks post-op, 3months post-op and 6 months post-op |
| visual analog scale | 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 | 3months post-op |
| visual analog scale | 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 | 6 months post-op |
| number of opioid pills | number of pills taken at each time point | 2 weeks post-op |
| number of opioid pills | number of pills taken at each time point | 6 weeks post-op |
| number of opioid pills | number of pills taken at each time point |
| Measure | Description | Time Frame |
|---|---|---|
| compliance of the intervention in the MM groups which will be tracked via the Headspace application. | used to detect the association between using the Headspace application and the amount of post-operative pain | 2 weeks post-op |
| compliance of the intervention in the MM groups which will be tracked via the Headspace application. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Banffy, MD | Cedar Sinai -Kerlan Jobe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kerlan Jobe | Los Angeles | California | 90045 | United States |
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| Patients will take standard post-op pain medication | Other | Standard post-op pain medication |
|
| 3 months post-op |
| number of opioid pills | number of pills taken at each time point | 6months post-op |
used to detect the association between using the Headspace application and the amount of post-operative pain |
| 6 weeks post-op |
| compliance of the intervention in the MM groups which will be tracked via the Headspace application. | used to detect the association between using the Headspace application and the amount of post-operative pain | 3 months post-op |
| compliance of the intervention in the MM groups which will be tracked via the Headspace application. | used to detect the association between using the Headspace application and the amount of post-operative pain | 6 months post-op |
| Patient reported out comes :Single Assessment Numeric Evaluation (SANE) | 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 | 2 weeks post-op |
| Patient reported out comes :Single Assessment Numeric Evaluation (SANE) | 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 | 6 weeks post-op |
| Patient reported out comes :Single Assessment Numeric Evaluation (SANE) | 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 | 3 months post-op |
| Patient reported out comes :Single Assessment Numeric Evaluation (SANE) | 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 | 6 moths post-op. |
| Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) | 12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health. | 2 weeks post-op. |
| Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) | 12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health. | 6 weeks post-op. |
| Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) | 12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health. | 3 months post-op. |
| Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) | 12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health. | 6 months post-op. |
| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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