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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 or disease	Intervention/treatment	Phase
Phobias	Behavioral: Psychological Treatment; Behavioral: Group Therapy	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
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
Study Start Date :	January 2008
Estimated Primary Completion Date :	June 2010
Estimated Study Completion Date :	January 2011

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 :

1. For pregnant subjects - labor preference, duration and pain medication assessment. [ Time Frame: post-labor ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Areskog B, Uddenberg N, Kjessler B. Fear of childbirth in late pregnancy. Gynecol Obstet Invest. 1981;12(5):262-6.

Eriksson C, Jansson L, Hamberg K. Women's experiences of intense fear related to childbirth investigated in a Swedish qualitative study. Midwifery. 2006 Sep;22(3):240-8. Epub 2006 Apr 17.

Hofberg K, Brockington I. Tokophobia: an unreasoning dread of childbirth. A series of 26 cases. Br J Psychiatry. 2000 Jan;176:83-5.

Hofberg K, Ward MR. Fear of childbirth, tocophobia, and mental health in mothers: the obstetric-psychiatric interface. Clin Obstet Gynecol. 2004 Sep;47(3):527-34. Review.

Alehagen S, Wijma K, Wijma B. Fear during labor. Acta Obstet Gynecol Scand. 2001 Apr;80(4):315-20.

Eriksson C, Westman G, Hamberg K. Experiential factors associated with childbirth-related fear in Swedish women and men: a population based study. J Psychosom Obstet Gynaecol. 2005 Mar;26(1):63-72.

Johnson R, Slade P. Does fear of childbirth during pregnancy predict emergency caesarean section? BJOG. 2002 Nov;109(11):1213-21.

Olde E, van der Hart O, Kleber R, van Son M. Posttraumatic stress following childbirth: a review. Clin Psychol Rev. 2006 Jan;26(1):1-16. Epub 2005 Sep 19. Review.

Saisto T, Halmesmäki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201-8. Review.

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 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