Use of a Self-Guided Mindfulness Mobile Application to Improve Pain Outcomes in Individuals With Knee Osteoarthritis

NCT03936088 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2022-09-13

No results posted yet for this study

Summary

This study will investigate if mindfulness training via a smartphone mobile app is effective in improving OA-related knee pain.

Conditions

  • Osteo Arthritis Knee
  • Pain

Interventions

DEVICE

Intervention -- "Headspace" mindfulness application

Patients will be provided with a pre-paid 12-week subscription to the mindfulness application, and provided an in-person demonstration on how to use it, and the subscription license code will be recorded for the purposes of tracking use after the conclusion of the study. The intervention group will be asked to use the mindfulness app 10 minutes per day/5 days per week. To standardize Pack usage across all participants, users will be asked to complete the Headspace Essentials", "Pain Management", and "Physical Health" Session Packs.

DEVICE

Control -- "My Water Balance" application

My Water Balance calculates an individual's recommended daily water requirements and assists users in tracking their daily fluid intake. The control group will be asked to log their water intake for the duration of the study, with requested use of 5 days per week to create an equal control. This application is free to download and use. There are options for in-app purchases and application upgrades, though users will be advised against doing so. Information logged in the application may be stored on a third party server; however, no application data will be extracted by the study team. Application use will be reported via weekly surveys, alone.

Sponsors & Collaborators

  • Mike O'Callaghan Military Hospital

    collaborator FED
  • 375th Medical Group, Scott Air Force Base

    collaborator FED
  • Travis AFB 60th Med Group

    collaborator UNKNOWN
  • jilliansylvester

    lead FED

Principal Investigators

  • Jillian E Sylvester, MD · US Air Force

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-02
Primary Completion
2022-09-12
Completion
2022-09-12

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03936088 on ClinicalTrials.gov