Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life
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|ClinicalTrials.gov Identifier: NCT00106717|
Recruitment Status : Completed
First Posted : March 30, 2005
Last Update Posted : March 20, 2008
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 or disease||Intervention/treatment||Phase|
|Cancer||Procedure: Narrative medicine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effectiveness of Narrative Medicine on Pain Intensity and Quality of Life|
|Study Start Date :||January 2004|
|Actual Study Completion Date :||August 2006|
- Pain intensity
- Pain interference with general activity, mood, work, relation with others, sleep, and enjoyment of life.
- Health related quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106717
|San Ignacio Hospital|
|Bogota, DC, Colombia|
|Principal Investigator:||M. Soledad Cepeda, MD, PhD||Javeriana University School of Medicine|