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

December 3, 2008 updated by: Tel-Aviv Sourasky Medical Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Aviv, Israel, 64239
        • Recruiting
        • Psychiatry Outpatient Clinic - Sourasky Medical Center
        • Sub-Investigator:
          • Shulamit Ben-Itzhak, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 - Pregnant - Tokophobic
Psychoanalysis treatment.
Behavioral: Psychological Treatment
15 weekly therapy sessions.
Other Names:
  • Cognitive Behavioral Therapy
  • CBT
  • Psychotherapy
  • Psychodynamic therapy
Experimental: 2 - Pregnant - Tokophobic
Cognitive-Behavioral treatment.
Behavioral: Psychological Treatment
15 weekly therapy sessions.
Other Names:
  • Cognitive Behavioral Therapy
  • CBT
  • Psychotherapy
  • Psychodynamic therapy
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
For pregnant subjects - labor preference, duration and pain medication assessment.
Time Frame: post-labor
post-labor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Investigators

  • Principal Investigator: Miki Bloch, M.D, Tel-Aviv Sourasky Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

December 3, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (Estimate)

December 4, 2008

Study Record Updates

Last Update Posted (Estimate)

December 4, 2008

Last Update Submitted That Met QC Criteria

December 3, 2008

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TASMC-08-MB-0064-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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