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:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

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:

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. (2001). Fear during labor. Acta Obstretricia & Gynecologica Scandinavica, 80: 315-320.

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
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

ClinicalTrials.gov processed this record on February 27, 2015

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