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

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04855968

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Tears	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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Sep 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: control (CON) 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 Standard post-op pain medication
Experimental: Mindfulness/Meditation (MM) 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. Patients will receive access to head space meditation application in addition to standard pain medication post surgery.

Arm

Intervention/Treatment

Active Comparator: control (CON)

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

Standard post-op pain medication

Experimental: Mindfulness/Meditation (MM)

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.

Patients will receive access to head space meditation application in addition to standard pain medication post surgery.

Outcome Measures

Primary Outcome Measures

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
visual analog scale [6 weeks post-op, 3months post-op and 6 months 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
visual analog scale [3months 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
visual analog scale [6 months 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
number of opioid pills [6 weeks post-op]
number of pills taken at each time point
number of opioid pills [3 months post-op]
number of pills taken at each time point
number of opioid pills [6months post-op]
number of pills taken at each time point

Secondary Outcome Measures

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
compliance of the intervention in the MM groups which will be tracked via the Headspace application. [6 weeks post-op]
used to detect the association between using the Headspace application and the amount of post-operative pain
compliance of the intervention in the MM groups which will be tracked via the Headspace application. [3 months post-op]
used to detect the association between using the Headspace application and the amount of post-operative pain
compliance of the intervention in the MM groups which will be tracked via the Headspace application. [6 months 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 :Single Assessment Numeric Evaluation (SANE) [6 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 :Single Assessment Numeric Evaluation (SANE) [3 months 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 :Single Assessment Numeric Evaluation (SANE) [6 moths 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.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) [6 weeks post-op.]
12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) [3 months post-op.]
12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) [6 months post-op.]
12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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