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

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.

Study Overview

• Status: Terminated
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: 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.

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Banffy, MD; Phone Number: 3106657200; Email: jasmine.galloway@cskerlanjobe.org
• Study Contact Backup: Name: KERLAN JOBE; Phone Number: (310) 665-7200; Email: jasmine.galloway@cskerlanjobe.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Kerlan Jobe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale	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	2 weeks post-op
visual analog scale	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	6 weeks post-op, 3months post-op and 6 months post-op
visual analog scale	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	3months post-op
visual analog scale	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	6 months post-op
number of opioid pills	number of pills taken at each time point	2 weeks post-op
number of opioid pills	number of pills taken at each time point	6 weeks post-op
number of opioid pills	number of pills taken at each time point	3 months post-op
number of opioid pills	number of pills taken at each time point	6months post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance of the intervention in the MM groups which will be tracked via the Headspace application.	used to detect the association between using the Headspace application and the amount of post-operative pain	2 weeks post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application.	used to detect the association between using the Headspace application and the amount of post-operative pain	6 weeks post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application.	used to detect the association between using the Headspace application and the amount of post-operative pain	3 months post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application.	used to detect the association between using the Headspace application and the amount of post-operative pain	6 months post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)	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	2 weeks post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)	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	6 weeks post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)	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	3 months post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)	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	6 moths post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)	12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.	2 weeks post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)	12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.	6 weeks post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)	12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.	3 months post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)	12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.	6 months post-op.

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Michael Banffy, MD, Cedar Sinai -Kerlan Jobe

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: April 20, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: mindfulness; biceps tenodesis; Shoulder Arthroscopy; Subacromial bursitis; head space
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Pain, Postoperative; Rotator Cuff Injuries; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Analgesics
• Other Study ID Numbers: STUDY00000950

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No