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

Primary Purpose

Rotator Cuff Tears

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
In addition to standard post-op medication patient will have access to the head space meditation application.
Patients will take standard post-op pain medication
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Tears focused on measuring Shoulder Arthroscopy, head space, mindfulness, Subacromial bursitis, biceps tenodesis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Kerlan JobeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control (CON)

Mindfulness/Meditation (MM)

Arm Description

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

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)

Outcomes

Primary Outcome Measures

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
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
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
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
number of opioid pills
number of pills taken at each time point
number of opioid pills
number of pills taken at each time point
number of opioid pills
number of pills taken at each time point
number of opioid pills
number of pills taken at each time point

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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.
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.
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.
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.

Full Information

First Posted
February 2, 2021
Last Updated
April 20, 2021
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04855968
Brief Title
The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption
Official Title
The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Tears
Keywords
Shoulder Arthroscopy, head space, mindfulness, Subacromial bursitis, biceps tenodesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control (CON)
Arm Type
Active Comparator
Arm Description
will receive the usual standard of care post-operative pain pills for the involved shoulder (Control Group)
Arm Title
Mindfulness/Meditation (MM)
Arm Type
Experimental
Arm 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)
Intervention Type
Other
Intervention Name(s)
In addition to standard post-op medication patient will have access to the head space meditation application.
Intervention Description
Patients will receive access to head space meditation application in addition to standard pain medication post surgery.
Intervention Type
Other
Intervention Name(s)
Patients will take standard post-op pain medication
Intervention Description
Standard post-op pain medication
Primary Outcome Measure Information:
Title
visual analog scale
Description
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
Time Frame
2 weeks post-op
Title
visual analog scale
Description
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
Time Frame
6 weeks post-op, 3months post-op and 6 months post-op
Title
visual analog scale
Description
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
Time Frame
3months post-op
Title
visual analog scale
Description
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
Time Frame
6 months post-op
Title
number of opioid pills
Description
number of pills taken at each time point
Time Frame
2 weeks post-op
Title
number of opioid pills
Description
number of pills taken at each time point
Time Frame
6 weeks post-op
Title
number of opioid pills
Description
number of pills taken at each time point
Time Frame
3 months post-op
Title
number of opioid pills
Description
number of pills taken at each time point
Time Frame
6months post-op
Secondary Outcome Measure Information:
Title
compliance of the intervention in the MM groups which will be tracked via the Headspace application.
Description
used to detect the association between using the Headspace application and the amount of post-operative pain
Time Frame
2 weeks post-op
Title
compliance of the intervention in the MM groups which will be tracked via the Headspace application.
Description
used to detect the association between using the Headspace application and the amount of post-operative pain
Time Frame
6 weeks post-op
Title
compliance of the intervention in the MM groups which will be tracked via the Headspace application.
Description
used to detect the association between using the Headspace application and the amount of post-operative pain
Time Frame
3 months post-op
Title
compliance of the intervention in the MM groups which will be tracked via the Headspace application.
Description
used to detect the association between using the Headspace application and the amount of post-operative pain
Time Frame
6 months post-op
Title
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
Description
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
Time Frame
2 weeks post-op
Title
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
Description
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
Time Frame
6 weeks post-op
Title
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
Description
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
Time Frame
3 months post-op
Title
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
Description
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
Time Frame
6 moths post-op.
Title
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
Description
12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Time Frame
2 weeks post-op.
Title
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
Description
12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Time Frame
6 weeks post-op.
Title
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
Description
12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Time Frame
3 months post-op.
Title
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
Description
12 question ,patient-reported global health measure that is used to assess a patient's overall perspective of their health.
Time Frame
6 months post-op.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Banffy, MD
Phone
3106657200
Email
jasmine.galloway@cskerlanjobe.org
First Name & Middle Initial & Last Name or Official Title & Degree
KERLAN JOBE
Phone
(310) 665-7200
Email
jasmine.galloway@cskerlanjobe.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Banffy, MD
Organizational Affiliation
Cedar Sinai -Kerlan Jobe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerlan Jobe
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine galloway
Phone
845-418-1534
Email
Jasmine.Galloway@cskerlanjobe.org
First Name & Middle Initial & Last Name & Degree
Michael banffy, md

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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