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CompletedNCT03460028Updated Apr 19, 2021

Yoga for Persistent Pain Related to Oncology Surgery

An interventional study of Yoga Condition in Persistent Postoperative Pain, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-04-19.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Persistent Postoperative Pain

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03

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Yoga Condition

    Participants randomized to the Yoga Condition will participate in a specialized yoga intervention.

    Behavioral: Yoga Condition

  • No intervention
    Wait-List Control Condition

    Participants randomized to the Wait-List Control Condition will participate in a specialized yoga intervention once the Yoga Condition has completed their assigned intervention.

Interventions

  • BehavioralYoga Condition

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

05

What researchers measure

Primary outcomes

  1. Change in scores on the Pain Catastrophizing Scale

    Time frame: at 0, 4 and 8 weeks

06

Study locations

1 site
  • Toronto General Hospital
    Toronto, Ontario M5G 2C4, Canada
07

Registry details

Key details

Study ID
NCT03460028
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
Mar 9, 2018
Start date
Apr 1, 2019
Primary completion
Jun 1, 2020
Completion
Mar 31, 2021
Last update
Apr 19, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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University Health Network, Toronto

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