Recruiting

Pain Tracking

Sponsor:

Johns Hopkins University

Code:

NCT04267588

Conditions

Pain, Chronic

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Navio Mobile App

Study Details

Brief summary:

Persistent pain is a public health epidemic. The current protocol seeks to develop technology to aid patients' tracking of patients' pain, medications and pain-related variables. The investigators seek to talk with patients in co-investigator's clinic to solicit feedback, as well as pilot test the technology with pain patients.

Conditions

Pain, Chronic

Study ID

NCT04267588

Start date

Aug 10, 2020

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ≥ 21 years of age
  • Pain duration > 3 months
  • Average pain level of >3 out of 10 (0=no pain; 10=worst pain imaginable)
  • English fluency
  • Are not scheduled to undergo any medical procedures during the course of the study
  • Have a physician-confirmed medical diagnosis associated with chronic pain
  • Are willing to comply with the study protocol and give written informed consent. Patients taking non-narcotic analgesics must be on a stable dose one month prior to participation.

Exclusion Criteria:

  • Delirium, dementia, or cognitive impairment (i.e., Mini Mental State Exam score <24)
  • Unstable major psychiatric disorder or history of schizophrenia
  • Beck Depression Inventory score >30 or report of suicidal ideation
  • Active substance abuse;
  • Refusal to provide access to relevant medical record information.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Navio App

The investigators propose to collect self-report and passively collected biological data and evaluate participants' relation to clinical and laboratory pain as well as patients' willingness to use and level of comfort with the mobile pain management digital platform and wearable biosensors. Eligible participants will be consented, given two biosensors (i.e., Apple Watch Series 1 with KardiaBand; Spire), a sleep monitoring device (actigraph watch), and a mobile app enabled smartphone, then trained on how to use the app (and device if appropriate) and biosensors. Participants will keep medications constant and not have any new pain treatment procedures over the course of the study period and 2 weeks prior to starting the study.

Interventions

Navio Mobile App

Participants will use the Navio Mobile App to track participants' pain and pain treatment

Primary outcome measure

  • Patterns of self-reported clinical Pain [ Time Frame: Up to 2 weeks ]
  • Patterns of Pain Catastrophizing [ Time Frame: Up to 2 weeks ]
  • Patterns of Positive Mood [ Time Frame: Up to 2 weeks ]
  • Patterns of Negative Mood [ Time Frame: Up to 2 weeks ]

Central Contacts and Locations

Central contacts

Luis F Buenaver, PhD

410-550-7000lbuenav1@jhmi.edu

Luis F Buenaver, Ph. D

410-550-7986lbuenav1@jhmi.edu

Locations

Behavioral Medicine Research Lab

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Katie Dunnock

410-550-6165

Principal Investigator:

Luis Buenaver, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-13.