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Fear of Childbirth (Tokophobia) - Etiology, Essence and Clinical Implications

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00801970
First Posted: December 4, 2008
Last Update Posted: December 4, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tel-Aviv Sourasky Medical Center
  Purpose

The purpose of this study is twofold:

  • to understand the etiology and the essence of fear of childbirth
  • to examine the implications and efficiency of several forms of psychological therapy.

Condition Intervention
Phobias Behavioral: Psychological Treatment Behavioral: Group Therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fear of Childbirth (Tokophobia) - Etiology, Essence and Clinical Implications

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Tokophobia existing and new measures (e.g. Pregnancy anxiety scale, Levin, 1991; Tokophobia subjective scale) [ Time Frame: Pre-treatment, Mid treatment, End of treatment ]

Secondary Outcome Measures:
  • For pregnant subjects - labor preference, duration and pain medication assessment. [ Time Frame: post-labor ]

Estimated Enrollment: 150
Study Start Date: January 2008
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - Pregnant - Tokophobic
Psychoanalysis treatment.
Behavioral: Psychological Treatment
15 weekly therapy sessions.
Other Names:
  • Psychotherapy
  • Psychodynamic therapy
  • Cognitive Behavioral Therapy
  • CBT
Experimental: 2 - Pregnant - Tokophobic
Cognitive-Behavioral treatment.
Behavioral: Psychological Treatment
15 weekly therapy sessions.
Other Names:
  • Psychotherapy
  • Psychodynamic therapy
  • Cognitive Behavioral Therapy
  • CBT
Experimental: 3 - Non-pregnant - Tokophobic
Group Therapy
Behavioral: Group Therapy
3 months of weekly group therapy sessions.
Other Names:
  • Psychotherapy
  • Group Psychotherapy
No Intervention: 4 - Control
Pregnant and non-pregnant non-tokophobic women will answer questionnaires. Won't receive therapy.

Detailed Description:
Fear of childbirth (Tokophobia) is inconsistently defined in the research literature: some define it as an anxiety disorder while it is often defined as a form of phobia; some regard only the pre-pregnancy period, some regard the anxiety during pregnancy and some focus on the labor process. Despite the high prevalence (between 13%-20% of fertile women), research in this area is scarce and the current findings are incohesive due to various conceptualizations of the phenomenon and to various measurement methods.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • subjective diagnosis of tokophobia

Exclusion Criteria:

  • currently undergoing psychological therapy
  • Major Depression
  • Acute Anxiety
  • Psychosis
  • Bipolar Disorder
  • Suicidal
  • Substance abuse
  • Non-compliant personality disorder
  • Health problems during pregnancy that affect perception
  Contacts and Locations
Information from the National Library of Medicine

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): NCT00801970


Contacts
Contact: Shulamit Ben-Itzhak, PhD 972-3-697-4567 shulamit@tasmc.health.gov.il

Locations
Israel
Psychiatry Outpatient Clinic - Sourasky Medical Center Recruiting
Tel Aviv, Israel, 64239
Sub-Investigator: Shulamit Ben-Itzhak, PhD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Miki Bloch, M.D Tel-Aviv Sourasky Medical Center
  More Information

Publications:
Responsible Party: Dr. Miki Bloch, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT00801970     History of Changes
Other Study ID Numbers: TASMC-08-MB-0064-CTIL
First Submitted: December 3, 2008
First Posted: December 4, 2008
Last Update Posted: December 4, 2008
Last Verified: December 2008

Keywords provided by Tel-Aviv Sourasky Medical Center:
Fear of childbirth
Tokophobia
Anxiety
Labor
Pregnancy
Cognitive-behavioral
Psychoanalysis
Group Therapy
etiology


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