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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00801970
First received: December 3, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • For pregnant subjects - labor preference, duration and pain medication assessment. [ Time Frame: post-labor ] [ Designated as safety issue: No ]

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

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 3, 2008
Last Updated: December 3, 2008
Health Authority: Israel: Ministry of Health

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

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014