PANDA-Regional Feasibility Study of a Smartphone Pain Management Application
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ClinicalTrials.gov Identifier: NCT03369392 |
Recruitment Status :
Completed
First Posted : December 12, 2017
Last Update Posted : April 19, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Postoperative Pain Anesthesia, Conduction | Other: Panda application | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 29 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | The At-home Feasibility Evaluation of PANDA-Regional, a Smartphone Application Designed to Support Post-operative Pain Management in Patients Undergoing Peripheral Nerve Blocks |
Actual Study Start Date : | December 11, 2017 |
Actual Primary Completion Date : | March 31, 2019 |
Actual Study Completion Date : | March 31, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: Feasibility Cycle 1
Participants use the initial PANDA application.
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Other: Panda application
A smartphone-based postoperative pain management tool |
Experimental: Feasibility Cycle 2
Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1.
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Other: Panda application
A smartphone-based postoperative pain management tool |
Experimental: Feasibility Cycle 3
Participants use the PANDA application after modifications are made based on suggestions from participants in cycle 1 and 2.
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Other: Panda application
A smartphone-based postoperative pain management tool |
- Feasibility of the PANDA application [ Time Frame: 2-7 days post-operatively ]Measured by assessing the participants' compliance with the application in supporting ongoing pain assessments and analgesic administration.
- Identify usability issues [ Time Frame: 2-7 days post-operatively ]Assessed by having participants complete a Computer Systems Usability Questionnaire (CSUQ) and a brief phone interview
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Ages Eligible for Study: | 19 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Undergoing ambulatory surgical procedures that require peripheral nerve blocks for which there is an anticipated post-surgical pain model
- Planned post-discharge analgesic medications including non-steroidal anti-inflammatory drugs, acetaminophen and/or opioids for at least 2 days
- ASA I-III
- Written informed consent
- Have a smartphone device at their disposal
Exclusion Criteria:
- Inability or refusal to provide informed consent
- Presence of significant cognitive impairment, visual impairments, neurological injury, or psychomotor dysfunction that impairs ability to use the app
- Inability to follow study instructions and complete questionnaires in English
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03369392
Canada, British Columbia | |
St. Paul's Hospital | |
Vancouver, British Columbia, Canada, V6Z 1Y6 |
Principal Investigator: | Ronald Ree, MD | University of British Columbia | |
Study Chair: | Cynthia Fan, MD | University of British Columbia | |
Study Chair: | Mark Ansermino, MBBCH | University of British Columbia | |
Study Chair: | Terri Sun, MD | University of British Columbia | |
Study Chair: | Lily Yu Long Chiu, MD | University of British Columbia | |
Study Chair: | Dustin Dunsmuir | University of British Columbia |
Responsible Party: | Ron Ree, Clinical Associate Professor, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT03369392 |
Other Study ID Numbers: |
H16-1196 |
First Posted: | December 12, 2017 Key Record Dates |
Last Update Posted: | April 19, 2019 |
Last Verified: | April 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |