The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Other: In addition to standard post-op medication patient will have access to the head space meditation application.
* Other: Patients will take standard post-op pain medication


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control (CON)<br>will receive the usual standard of care post-operative pain pills for the involved shoulder (Control Group) | Other: Patients will take standard post-op pain medication<br>* Standard post-op pain medication<br>|
| Experimental: Mindfulness/Meditation (MM)<br>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) | Other: In addition to standard post-op medication patient will have access to the head space meditation application.<br>* Patients will receive access to head space meditation application in addition to standard pain medication post surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 3 months post-op | 
| number of opioid pills | number of pills taken at each time point | 6months post-op | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Arthroscopy, head space, mindfulness, Subacromial bursitis, biceps tenodesis