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

Phobias Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00801970
• Other study ID #: TASMC-08-MB-0064-CTIL
• Status: Recruiting
• Phase: N/A
• First received: December 3, 2008
• Last updated: December 3, 2008
• Start date: January 2008
• Est. completion date: January 2011

Study information

• Verified date: December 2008
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Shulamit Ben-Itzhak, PhD
• Phone: 972-3-697-4567
• Email: shulamit[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobias

Intervention

Behavioral:
• Psychological Treatment
15 weekly therapy sessions.
• Group Therapy
3 months of weekly group therapy sessions.

Locations

Country	Name	City	State
Israel	Psychiatry Outpatient Clinic - Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (9)

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

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tokophobia existing and new measures (e.g. Pregnancy anxiety scale, Levin, 1991; Tokophobia subjective scale)		Pre-treatment, Mid treatment, End of treatment	No
Secondary	For pregnant subjects - labor preference, duration and pain medication assessment.		post-labor	No