Rotator Cuff TearsNCT04855968
The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption
A study testing In addition to standard post-op medication patient will have access to the head space meditation application. and Patients will take standard post-op pain medication in people with Rotator Cuff Tears, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- In addition to standard post-op medication patient will have access to the head space meditation application. and Patients will take standard post-op pain medication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or Mumford Procedure
Who cannot join
- Less than 18 years old
- Patients undergoing a simultaneous arthroscopic procedure that is not in the inclusion criteria.
- History of shoulder osteoarthritis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- 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
- Keywords
- Shoulder Arthroscopy, head space, mindfulness, Subacromial bursitis, biceps tenodesis
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In addition to standard post-op medication patient will have access to the head space meditation application.Other
Patients will receive access to head space meditation application in addition to standard pain medication post surgery.
Patients will take standard post-op pain medicationOther
Standard post-op pain medication
| Study group | Role | What they receive |
|---|---|---|
| control (CON) | Active comparator | will receive the usual standard of care post-operative pain pills for the involved shoulder (Control Group) Receives: Other: Patients will take standard post-op pain medication |
| Mindfulness/Meditation (MM) | Experimental | 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) Receives: Other: In addition to standard post-op medication patient will have access to the head space meditation application. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months post-op
number of opioid pills
number of pills taken at each time point
Measured: 2 weeks post-op
number of opioid pills
number of pills taken at each time point
Measured: 6 weeks post-op
number of opioid pills
number of pills taken at each time point
Measured: 3 months post-op
number of opioid pills
number of pills taken at each time point
Measured: 6months post-op
Secondary outcomes (12)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months post-op.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Sep 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Why it stopped: Poor patient compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Banffy, MD, Cedars-Sinai Medical Center
- Investigators
- Michael Banffy, MD, Principal investigator, Cedar Sinai -Kerlan Jobe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855968
- Sponsor's protocol ID
- STUDY00000950
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness/Meditation on Post-operative Pain and Opioid Consumption
- ClinicalTrials.gov ID
- NCT04855968
- Acronym / sponsor ID
- STUDY00000950
- Conditions
- Rotator Cuff Tears
- Keywords
- Shoulder Arthroscopy, head space, mindfulness, Subacromial bursitis, biceps tenodesis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor patient compliance
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control (CON) | Active comparator | Other: Patients will take standard post-op pain medicationwill receive the usual standard of care post-operative pain pills for the involved shoulder (Control Group) |
| Mindfulness/Meditation (MM) | Experimental | Other: In addition to standard post-op medication patient will have access to the head space meditation application.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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- Status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or Mumford Procedure
Key exclusion criteria (3 listed)
- Less than 18 years old
- Patients undergoing a simultaneous arthroscopic procedure that is not in the inclusion criteria.
- History of shoulder osteoarthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Mindfulness/Meditation (MM) |
| Patients will take standard post-op pain medicationStandard post-op pain medication | Other | control (CON) |
Primary outcome
visual analog scale
Time frame: 2 weeks post-op
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
Time frame: 6 weeks post-op, 3months post-op and 6 months post-op
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
Time frame: 3months post-op
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
Time frame: 6 months post-op
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
Time frame: 2 weeks post-op
number of pills taken at each time point
number of opioid pills
Time frame: 6 weeks post-op
number of pills taken at each time point
number of opioid pills
Time frame: 3 months post-op
number of pills taken at each time point
number of opioid pills
Time frame: 6months post-op
number of pills taken at each time point
12 secondary outcomes
compliance of the intervention in the MM groups which will be tracked via the Headspace application.
Time frame: 2 weeks post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application.
Time frame: 6 weeks post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application.
Time frame: 3 months post-op
compliance of the intervention in the MM groups which will be tracked via the Headspace application.
Time frame: 6 months post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
Time frame: 2 weeks post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
Time frame: 6 weeks post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
Time frame: 3 months post-op
Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
Time frame: 6 moths post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
Time frame: 2 weeks post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
Time frame: 6 weeks post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
Time frame: 3 months post-op.
Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
Time frame: 6 months post-op.
Results and safety
The study was stopped early (reason given: Poor patient compliance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Banffy, MD principal investigator
Cedar Sinai -Kerlan Jobe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In addition to standard post-op medication patient will have access to the head space meditation application. and Patients will take standard post-op pain medication in people with Rotator Cuff Tears, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor patient compliance). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (time frame: 2 weeks post-op). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.