Clinical trial NCT04855968: 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
Overall status: TERMINATED
Phase: NA
Conditions: Rotator Cuff Tears
Keywords: Shoulder Arthroscopy
head space
mindfulness
Subacromial bursitis
biceps tenodesis
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: visual analog scale
timeFrame: 2 weeks post-op
measure: visual analog scale
timeFrame: 6 weeks post-op, 3months post-op and 6 months post-op
measure: visual analog scale
timeFrame: 3months post-op
measure: visual analog scale
timeFrame: 6 months post-op
measure: number of opioid pills
timeFrame: 2 weeks post-op
measure: number of opioid pills
timeFrame: 6 weeks post-op
measure: number of opioid pills
timeFrame: 3 months post-op
measure: number of opioid pills
timeFrame: 6months post-op
Secondary outcomes:
measure: compliance of the intervention in the MM groups which will be tracked via the Headspace application.
timeFrame: 2 weeks post-op
measure: compliance of the intervention in the MM groups which will be tracked via the Headspace application.
timeFrame: 6 weeks post-op
measure: compliance of the intervention in the MM groups which will be tracked via the Headspace application.
timeFrame: 3 months post-op
measure: compliance of the intervention in the MM groups which will be tracked via the Headspace application.
timeFrame: 6 months post-op
measure: Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
timeFrame: 2 weeks post-op
measure: Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
timeFrame: 6 weeks post-op
measure: Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
timeFrame: 3 months post-op
measure: Patient reported out comes :Single Assessment Numeric Evaluation (SANE)
timeFrame: 6 moths post-op.
measure: Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: 2 weeks post-op.
measure: Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: 6 weeks post-op.
measure: Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: 3 months post-op.
measure: Patient reported out comes: The Veterans RAND 12 Item Health Survey (VR-12)
timeFrame: 6 months post-op.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kerlan Jobe
state: California
Study officials:
affiliation: Cedar Sinai -Kerlan Jobe
name: Michael Banffy, MD
role: PRINCIPAL_INVESTIGATOR
References: