Chronic Pain Clinical Trial
Official title:
Jazz Music and Mindfulness for Chronic Pain
NCT number | NCT05979012 |
Other study ID # | #3454 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2023 |
Est. completion date | October 2023 |
Verified date | July 2023 |
Source | University of California, Irvine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic pain, including spinal pain and osteoarthritis, is the leading cause of years lived with disability world-wide and the costliest health condition in the U.S. today. Compounding these concerns, opioid analgesics remain the primary pharmacological treatment for chronic pain. An estimated 21-29% of chronic pain patients receiving long-term opioid therapy develop opioid misuse, and opioid misuse portends addiction and overdose. Clearly, chronic pain patients need better, non-addictive treatment options designed to reverse the downward spiral of chronic pain.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | October 2023 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Are 18+ 2. Live in the US 3. Are an English-proficient adult with a chronic pain diagnosis (no restrictions placed on type) 4. Have a pain rating of four or greater in average pain on a 0-10 numeric rating scale in the preceding week 5. Have had pain for at least 3 months and for at least 15 days in the preceding 30 days 6. Have moderate to severe anxiety based on GAD-7 Exclusion Criteria: 1. Are currently using or have used prescription opioids in the past 3 months to minimize a known treatment confound and increase sample homogeneity 2. Have a current cancer diagnosis |
Country | Name | City | State |
---|---|---|---|
United States | University of California Irvine | Irvine | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Irvine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Self-Efficacy | Pain self-efficacy, which refers to participants' confidence in their ability to manage pain, will be assessed using the Pain Self-Efficacy Questionnaire. | 4 weeks | |
Primary | Global Satisfaction with Treatment | Participants' overall satisfaction with the treatment will be measured using the Patients' Global Impression of Change (PGIC) scale. | 4 weeks | |
Secondary | Pain Intensity | The PEG scale will be used to assess the magnitude of pain sensations experienced by participants in the past week. | 4 weeks | |
Secondary | Pain Interference | The degree of pain interference in different aspects of participants' lives will be evaluated using the PEG scale. | 4 weeks |
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