Impact of a Course on Stress Reduction (YOGA)
| Tracking Information | |||||
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| First Received Date ICMJE | May 12, 2009 | ||||
| Last Updated Date | May 6, 2010 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Performance and Satisfaction using Canadian Occupational Performance Measure (COPM) [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Stress reduction in chronic pain patients which will positively impact their daily lives with an increase of level of function and an overall improvement in their quality of life. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00902863 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Pain relief using VAS and pain scores [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Pain relief [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of a Course on Stress Reduction | ||||
| Official Title ICMJE | The Impact of a Course on Stress Reduction Techniques on Satisfaction, Stress, Performance, and Quality of Life in Patients With Chronic Pain | ||||
| Brief Summary | This project seeks to measure the effectiveness of a course in self-management strategies (including yoga, mindfulness, and breathing exercises). The course will be provided by a certified yoga instructor to patients being followed at the Pain Management Centre, Hamilton Health Sciences (HHS). |
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| Detailed Description | The Pain Management Centre at Hamilton Health Sciences is organizing a course in stress reduction techniques for patients with chronic pain. The Pain Centre has arranged for a local certified yoga instructor to lead a 6-week course that she has developed for our specific patient population. The course will include self-management strategies for pain control, such as breathing exercises, yoga poses, and mindfulness meditation. Standardized questionnaires and a semi-structured interview to record baseline and post-course outcomes. The study will involve the following questionnaires/surveys/interviews: 1) Canadian Occupational Performance Measure, 2) Perceived Stress Scale, 3) Burckhardt Quality of Life Scale, 4) Visual Analog Score, and 5) written questions concerning patient demographics, the patient's chronic pain condition, and their satisfaction with the course. The participants would be asked to fill out questionnaires at three different times: 1) baseline data collected within two weeks of starting course, 2) short-term outcome data within two weeks of completing course, and 3) long-term outcome data four to six months after the course. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Chronic Pain | ||||
| Intervention ICMJE | Behavioral: YOGA
Patients with chronic pain will undergo a six week course of YOGA |
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| Study Arm (s) | Experimental: YOGA patients
Patients assessed for chronic pain at our Pain Management Centre
Intervention: Behavioral: YOGA |
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| Publications * | Mead K, Theadom A, Byron K, Dupont S. Pilot study of a 4-week Pain Coping Strategies (PCS) programme for the chronic pain patient. Disabil Rehabil. 2007 Feb 15;29(3):199-203. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 5 | ||||
| Completion Date | March 2010 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00902863 | ||||
| Other Study ID Numbers ICMJE | 08-070 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Lori Olivieri, Hamilton Health Sciences | ||||
| Study Sponsor ICMJE | Hamilton Health Sciences Corporation | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||
| Verification Date | May 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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