Persistent Postoperative Pain Clinical Trial
Official title:
Evaluation of the Transitional Pain Service Surgical Oncology Yoga Program for Individuals With Persistent Pain; a Pilot Randomized Controlled Trial
NCT number | NCT03460028 |
Other study ID # | 17-5942.0 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | March 31, 2021 |
Verified date | April 2021 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized controlled trial will evaluate a yoga intervention for individuals who experience persistent pain following oncology surgery. The integrated yoga program will involve postures, breathing exercises, and concentration practices. Data will be collected at several time points (pre-, mid-, and post-intervention) for both the intervention and wait-list control conditions. The data will be analysed using linear mixed effects growth models. Results will be written up in manuscript format, published in a peer review journal, and disseminated at scientific research conferences.
Status | Completed |
Enrollment | 23 |
Est. completion date | March 31, 2021 |
Est. primary completion date | June 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: 1. Is a patient at specific pain clinics 2. Has undergone oncology surgery prior to commencing the yoga intervention 3. Is 18 years of age or older 4. Is able to speak and read English 5. Is able to commit to one weekly, one hour yoga classes for eight weeks 6. Is able to provide a note from their physician or kinesiologist indicating that it is safe for them to participate in a gentle physical activity intervention, such as yoga Exclusion Criteria: 1. Has pre-existing medical contraindications that preclude participation 2. Has cognitive limitations or language comprehension issues that would impact participation 3. Have had a regular yoga practice in the last six months 4. Documented personality disorder 5. Pregnant women 6. Current enrollment in another research trial evaluating a mind-body intervention |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto General Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in scores on the Pain Catastrophizing Scale | at 0, 4 and 8 weeks |
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