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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04855968
• Other study ID #: STUDY00000950
• Status: Terminated
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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.
• Patients will take standard post-op pain medication
Standard post-op pain medication

Locations

Country	Name	City	State
United States	Kerlan Jobe	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	number of opioid pills	number of pills taken at each time point	2 weeks post-op
Primary	number of opioid pills	number of pills taken at each time point	6 weeks post-op
Primary	number of opioid pills	number of pills taken at each time point	3 months post-op
Primary	number of opioid pills	number of pills taken at each time point	6months post-op
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.