NCT04855968

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 8, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

February 2, 2021

Last Update Submit

February 6, 2024

Conditions

Rotator Cuff Tears

Keywords

Shoulder Arthroscopyhead spacemindfulnessSubacromial bursitisbiceps tenodesis

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (12)

  • compliance of the intervention in the MM groups which will be tracked via the Headspace application.

    2 weeks post-op

  • compliance of the intervention in the MM groups which will be tracked via the Headspace application.

    6 weeks post-op

  • compliance of the intervention in the MM groups which will be tracked via the Headspace application.

    3 months post-op

  • compliance of the intervention in the MM groups which will be tracked via the Headspace application.

    6 months post-op

  • Patient reported out comes :Single Assessment Numeric Evaluation (SANE)

    2 weeks post-op

  • +7 more secondary outcomes

Study Arms (2)

control (CON)

ACTIVE COMPARATOR

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

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)

Other: In addition to standard post-op medication patient will have access to the head space meditation application.

Interventions

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.

Mindfulness/Meditation (MM)
Patients will take standard post-op pain medicationOTHER

Standard post-op pain medication

control (CON)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Status post shoulder arthroscopy for rotator cuff repair, biceps tendinopathy, and/or Mumford Procedure

You may not qualify if:

  • Less than 18 years old
  • History of shoulder osteoarthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerlan Jobe

Los Angeles, California, 90045, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

RuptureWounds and InjuriesShoulder InjuriesTendon Injuries

Study Officials

  • Michael Banffy, MD

    Cedar Sinai -Kerlan Jobe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 2, 2021

First Posted

April 22, 2021

Study Start

September 1, 2020

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

February 8, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)