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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2021
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga Condition
Participants randomized to the Yoga Condition will participate in an integrated yoga program consisting of yoga postures, breathing exercises, and concentration/meditation practices.

Locations

Country Name City State
Canada Toronto General Hospital Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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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