Back to resultsYoga for Persistent Pain Related to Oncology Surgery
Primary Purpose
Persistent Postoperative Pain
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Yoga Condition
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Is a patient at specific pain clinics
- Has undergone oncology surgery prior to commencing the yoga intervention
- Is 18 years of age or older
- Is able to speak and read English
- Is able to commit to one weekly, one hour yoga classes for eight weeks
- 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:
- Has pre-existing medical contraindications that preclude participation
- Has cognitive limitations or language comprehension issues that would impact participation
- Have had a regular yoga practice in the last six months
- Documented personality disorder
- Pregnant women
- Current enrollment in another research trial evaluating a mind-body intervention
Sites / Locations
- Toronto General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Yoga Condition
Wait-List Control Condition
Arm Description
Participants randomized to the Yoga Condition will participate in a specialized yoga intervention.
Participants randomized to the Wait-List Control Condition will participate in a specialized yoga intervention once the Yoga Condition has completed their assigned intervention.
Outcomes
Primary Outcome Measures
Change in scores on the Pain Catastrophizing Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT03460028
First Posted
October 17, 2017
Last Updated
April 16, 2021
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03460028
Brief Title
Yoga for Persistent Pain Related to Oncology Surgery
Official Title
Evaluation of the Transitional Pain Service Surgical Oncology Yoga Program for Individuals With Persistent Pain; a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
March 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga Condition
Arm Type
Experimental
Arm Description
Participants randomized to the Yoga Condition will participate in a specialized yoga intervention.
Arm Title
Wait-List Control Condition
Arm Type
No Intervention
Arm Description
Participants randomized to the Wait-List Control Condition will participate in a specialized yoga intervention once the Yoga Condition has completed their assigned intervention.
Intervention Type
Behavioral
Intervention Name(s)
Yoga Condition
Intervention Description
Participants randomized to the Yoga Condition will participate in an integrated yoga program consisting of yoga postures, breathing exercises, and concentration/meditation practices.
Primary Outcome Measure Information:
Title
Change in scores on the Pain Catastrophizing Scale
Time Frame
at 0, 4 and 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Is a patient at specific pain clinics
Has undergone oncology surgery prior to commencing the yoga intervention
Is 18 years of age or older
Is able to speak and read English
Is able to commit to one weekly, one hour yoga classes for eight weeks
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:
Has pre-existing medical contraindications that preclude participation
Has cognitive limitations or language comprehension issues that would impact participation
Have had a regular yoga practice in the last six months
Documented personality disorder
Pregnant women
Current enrollment in another research trial evaluating a mind-body intervention
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
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Yoga for Persistent Pain Related to Oncology Surgery
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