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

Cedars-Sinai Medical Center

Status: Terminated

Conditions: Rotator Cuff Tears

Treatments: Other: Patients will take standard post-op pain medication; Other: In addition to standard post-op medication patient will have access to the head space meditation application.

Study type: Interventional

Funder types: Other

Identifiers

NCT04855968

STUDY00000950

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

control (CON)

Active Comparator group

Description:

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

Treatment:

Other: Patients will take standard post-op pain medication

Mindfulness/Meditation (MM)

Experimental group

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)

Treatment:

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