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Expressive Writing in Male Infertility

Primary Purpose

Infertility, Male

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Expressive writing
Sponsored by
University Hospital, Bonn
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility, Male focused on measuring Expressive writing, Male infertility

Eligibility Criteria

18 Years - 55 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Bonn, Department of Psychosomatic Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

A 1

Arm Description

Expressive writing

Outcomes

Primary Outcome Measures

Scores on rating scale for perceived stress in infertility

Secondary Outcome Measures

Scores on rating scale for personality dimensions
Sperm parameters
Score on rating scale for coping

Full Information

First Posted
October 5, 2006
Last Updated
June 29, 2010
Sponsor
University Hospital, Bonn
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1. Study Identification

Unique Protocol Identification Number
NCT00385346
Brief Title
Expressive Writing in Male Infertility
Official Title
Expressive Writing as a Therapeutic Intervention in Male Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bonn

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
Keywords
Expressive writing, Male infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A 1
Arm Type
Experimental
Arm Description
Expressive writing
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Scores on rating scale for perceived stress in infertility
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Scores on rating scale for personality dimensions
Time Frame
3 months
Title
Sperm parameters
Time Frame
3-12 months
Title
Score on rating scale for coping
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male infertile patients with a pathological spermiogram according to WHO criteria Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Liedtke, MD
Organizational Affiliation
University of Bonn, Department of Psychosomatic Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
University of Bonn, Department of Psychosomatic Medicine
City
Bonn
ZIP/Postal Code
53105
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
12552631
Citation
Smyth J, Helm R. Focused expressive writing as self-help for stress and trauma. J Clin Psychol. 2003 Feb;59(2):227-35. doi: 10.1002/jclp.10144.
Results Reference
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PubMed Identifier
12433015
Citation
de Moor C, Sterner J, Hall M, Warneke C, Gilani Z, Amato R, Cohen L. A pilot study of the effects of expressive writing on psychological and behavioral adjustment in patients enrolled in a Phase II trial of vaccine therapy for metastatic renal cell carcinoma. Health Psychol. 2002 Nov;21(6):615-9. doi: 10.1037//0278-6133.21.6.615.
Results Reference
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PubMed Identifier
15039514
Citation
Petrie KJ, Fontanilla I, Thomas MG, Booth RJ, Pennebaker JW. Effect of written emotional expression on immune function in patients with human immunodeficiency virus infection: a randomized trial. Psychosom Med. 2004 Mar-Apr;66(2):272-5. doi: 10.1097/01.psy.0000116782.49850.d3.
Results Reference
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PubMed Identifier
11227757
Citation
Pennebaker JW. The effects of traumatic disclosure on physical and mental health: the values of writing and talking about upsetting events. Int J Emerg Ment Health. 1999 Winter;1(1):9-18.
Results Reference
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PubMed Identifier
10740948
Citation
Richards JM, Beal WE, Seagal JD, Pennebaker JW. Effects of disclosure of traumatic events on illness behavior among psychiatric prison inmates. J Abnorm Psychol. 2000 Feb;109(1):156-60. doi: 10.1037//0021-843x.109.1.156.
Results Reference
background
PubMed Identifier
9866186
Citation
Petrie KJ, Booth RJ, Pennebaker JW. The immunological effects of thought suppression. J Pers Soc Psychol. 1998 Nov;75(5):1264-72. doi: 10.1037//0022-3514.75.5.1264.
Results Reference
background
PubMed Identifier
7593871
Citation
Petrie KJ, Booth RJ, Pennebaker JW, Davison KP, Thomas MG. Disclosure of trauma and immune response to a hepatitis B vaccination program. J Consult Clin Psychol. 1995 Oct;63(5):787-92. doi: 10.1037//0022-006x.63.5.787.
Results Reference
background
PubMed Identifier
3372832
Citation
Pennebaker JW, Kiecolt-Glaser JK, Glaser R. Disclosure of traumas and immune function: health implications for psychotherapy. J Consult Clin Psychol. 1988 Apr;56(2):239-45. doi: 10.1037//0022-006x.56.2.239. No abstract available.
Results Reference
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Expressive Writing in Male Infertility

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