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

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

Sponsors

Lead Sponsor: Cedars-Sinai Medical Center

Source Cedars-Sinai Medical Center
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.

Overall Status Recruiting
Start Date 2020-09-01
Completion Date 2021-09-01
Primary Completion Date 2021-09-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
visual analog scale 2 weeks post-op
visual analog scale 6 weeks post-op, 3months post-op and 6 months post-op
visual analog scale 3months post-op
visual analog scale 6 months post-op
number of opioid pills 2 weeks post-op
number of opioid pills 6 weeks post-op
number of opioid pills 3 months post-op
number of opioid pills 6months post-op
Secondary Outcome
Measure Time Frame
compliance of the intervention in the MM groups which will be tracked via the Headspace application. 2 weeks post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application. 6 weeks post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application. 3 months post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application. 6 months post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE) 2 weeks post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE) 6 weeks post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE) 3 months post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE) 6 moths post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) 2 weeks post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) 6 weeks post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) 3 months post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12) 6 months post-op.
Enrollment 44
Condition
Intervention

Intervention Type: Other

Intervention Name: In addition to standard post-op medication patient will have access to the head space meditation application.

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

Arm Group Label: Mindfulness/Meditation (MM)

Intervention Type: Other

Intervention Name: Patients will take standard post-op pain medication

Description: Standard post-op pain medication

Arm Group Label: control (CON)

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Michael Banffy, MD Principal Investigator Cedar Sinai -Kerlan Jobe
Overall Contact

Last Name: Michael Banffy, MD

Phone: 3106657200

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Kerlan Jobe Jasmine galloway 845-418-1534 [email protected] Michael banffy, md Principal Investigator
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cedars-Sinai Medical Center

Investigator Full Name: Michael Banffy, MD

Investigator Title: Principal investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: control (CON)

Type: Active Comparator

Description: will receive the usual standard of care post-operative pain pills for the involved shoulder (Control Group)

Label: Mindfulness/Meditation (MM)

Type: Experimental

Description: 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)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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