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

NCT ID: NCT04855968

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-09-01

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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control (CON)

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

Group Type: ACTIVE_COMPARATOR

Patients will take standard post-op pain medication

Intervention Type: OTHER

Standard post-op pain medication

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)

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Patients will take standard post-op pain medication

Standard post-op pain medication

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years and older
• Status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or Mumford Procedure

• History of shoulder osteoarthritis

Exclusion Criteria

• Less than 18 years old

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Michael Banffy, MD

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Banffy, MD

Role: PRINCIPAL_INVESTIGATOR

Cedar Sinai -Kerlan Jobe

Locations

Kerlan Jobe

Los Angeles, California, United States

Countries

United States

Other Identifiers

STUDY00000950

Identifier Type: -

Identifier Source: org_study_id