NCT04855968

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rotator Cuff Tears

Interventions

Type	Name	Description
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.
OTHER	Patients will take standard post-op pain medication	Standard post-op pain medication

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2021-04-22
• Last updated: 2024-02-08

Locations

1 site across 1 country: United States