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临床试验/NCT00385346
NCT00385346已完成不适用

Expressive Writing as a Therapeutic Intervention in Male Infertility

University Hospital, Bonn2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2006年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
2
主要终点
Scores on rating scale for perceived stress in infertility

研究概览

简要总结

The purpose of this study is to determine whether expressive writing can be effective in improving the well-being and sperm quality in patients with male infertility.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male infertile patients with a pathological spermiogram according to WHO criteria

排除标准

  • Drugs affecting sperm quality
  • Patients with chromosomal anomalies affecting sperm quality (e.g. Klinefelter- Syndrome)
  • Severe Psychiatric disorder defined as psychotic disorder (schizophrenia, bipolar disorder) or substance-related disorder
  • Patients currently in psychotherapeutic or psychiatric therapy

结局指标

主要结局

Scores on rating scale for perceived stress in infertility

时间窗: 3 months

次要结局

  • Sperm parameters(3-12 months)
  • Scores on rating scale for personality dimensions(3 months)
  • Score on rating scale for coping(3 months)

研究者

发起方
University Hospital, Bonn
申办方类型
Other

研究点 (2)

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