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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
Recruitment status was: Recruiting
Sponsor:
Tel-Aviv Sourasky Medical Center
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
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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: 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:
|
|
Experimental: 2 - Pregnant - Tokophobic
Cognitive-Behavioral treatment.
|
Behavioral: Psychological Treatment
15 weekly therapy sessions.
Other Names:
|
|
Experimental: 3 - Non-pregnant - Tokophobic
Group Therapy
|
Behavioral: Group Therapy
3 months of weekly group therapy sessions.
Other Names:
|
|
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| 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
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
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 |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Fear of childbirth Tokophobia Anxiety Labor Pregnancy |
Cognitive-behavioral Psychoanalysis Group Therapy etiology |
ClinicalTrials.gov processed this record on July 19, 2017