Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life
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Purpose
Narrative medicine addresses the therapeutic benefits that derive from patients forming and telling their personal stories. It offers an innovative model for improving health outcomes. When a patient with cancer and marked suffering writes a narrative of what he or she is going through, this process may reduce pain and improve quality of life.
Therefore, we seek to evaluate the effectiveness of writing a narrative on pain intensity and health related quality of life.
We propose a randomized single blind (evaluator) controlled trial. Patients with cancer pain of intensity at least 5/10 with a minimum Karnofsky score of 50% will be randomized into three groups: 1. Narrative group. Patients will write a story about their illness for at least 20 minutes once a week for 3 weeks; 2. Writing-control group. Patients will fill a pain diary once a week for three weeks; 3. Control group. Subjects will not write/fill anything. Pain will be evaluated using the numerical scale before randomization and then weekly for 8 weeks. We will also evaluate how pain interferes with general activity, mood, work, relation with others, sleep, and enjoyment of life using the Brief Pain Inventory. As secondary outcomes, we will evaluate health related quality of life, with the treatment outcomes of pain survey, which is a modification of the SF 36 (short form health survey), and a global measure of well-being before randomization, and then at 4 and 8 weeks. We will also evaluate the emotional disclosure of the narratives.
We will use an intention to treat analysis. To analyze the effect of the treatment on pain intensity, quality of life, and well-being, we will employ an analysis of repeated measures using generalized estimating equations. We will include in the regression models the treatment group, the emotional disclosure score, the time, and the interaction between treatment group and time.
| Condition | Intervention |
|---|---|
|
Cancer |
Procedure: Narrative medicine |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
| Official Title: | Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life |
- Pain intensity
- Pain interference with general activity, mood, work, relation with others, sleep, and enjoyment of life.
- Health related quality of life
| Estimated Enrollment: | 210 |
| Study Start Date: | January 2004 |
| Study Completion Date: | August 2006 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with cancer pain of intensity at least 5/10 with a minimum Karnofsky score of 50%
Exclusion Criteria:
- Patients unable to write or read
Contacts and Locations
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00106717 History of Changes |
| Other Study ID Numbers: | 1736 |
| Study First Received: | March 29, 2005 |
| Last Updated: | March 19, 2008 |
| Health Authority: | Colombia: Institutional Review Board |
Keywords provided by Javeriana University:
|
Cancer pain Quality of life Narrative medicine Pain relief |
ClinicalTrials.gov processed this record on May 19, 2013