Expressive Writing in Male Infertility
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Expressive Writing as a Therapeutic Intervention in Male Infertility|
- Scores on rating scale for perceived stress in infertility [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Scores on rating scale for personality dimensions [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Sperm parameters [ Time Frame: 3-12 months ] [ Designated as safety issue: No ]
- Score on rating scale for coping [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||February 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Experimental: A 1
Behavioral: Expressive writing
Patients in the intervention group write on three day for 20 minutes about highly emotional topics In the control group patients write on three days for 20 minutes about topics with relatively low emotional involvement such as diet, time management and sport.
Expressive writing is a therapeutic intervention designed by the psychologist James W. Pennebaker. Individuals write on three days for about 20 minutes about particularly stressful experiences in their life. Several studies showed that expressive writing can have beneficial effects on the frequency of health care utilization and well-being. Particularly in patients with rheumatism, kidney cancer and posttraumatic stress disorder expressive writing showed an positive effect on subjective well-being. Furthermore, in several studies expressive writing showed a positive effect on immune parameters.
As many studies suggest an important negative effect of stress on well-being and sperm parameters in male infertility, we want to investigate the effect of expressive writing in male infertility.The expressive writing condition is compared to a non emotional writing condition, in which individuals write about mainly non emotional topics such as time management. In this randomized-controlled trial subjects were allocated sequentially by block wise randomization (block size of 4). For randomization a computer generated random list was used. The allocation was concealed in a series of numbered sealed envelopes. The envelope was opened immediately before the first writing session.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385346
|University of Bonn, Department of Psychosomatic Medicine|
|Bonn, Germany, 53105|
|Study Chair:||Reinhard Liedtke, MD||University of Bonn, Department of Psychosomatic Medicine|