PhobiasNCT00801970
Fear of Childbirth (Tokophobia) - Etiology, Essence and Clinical Implications
A study testing Psychological Treatment and Group Therapy in people with Phobias, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Phobias
- What is being tested?
- Psychological Treatment and Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- subjective diagnosis of tokophobia
Who cannot join
- currently undergoing psychological therapy
- Major Depression
- Acute Anxiety
- Psychosis
- Bipolar Disorder
- Suicidal
Show all 9Show fewer
- Substance abuse
- Non-compliant personality disorder
- Health problems during pregnancy that affect perception
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Psychiatry Outpatient Clinic - Sourasky Medical Center
Tel Aviv, 64239
Shulamit Ben-Itzhak, PhD
About this study
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.
Read the 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.
- Conditions
- Phobias
- Being tested
- Psychological Treatment, Group Therapy
- Keywords
- Fear of childbirth, Tokophobia, Anxiety, Labor, Pregnancy, Cognitive-behavioral, Psychoanalysis, Group Therapy, etiology
- Medical subject headings
- Phobic Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological TreatmentBehavioural
Also called Psychotherapy, Psychodynamic therapy, Cognitive Behavioral Therapy, CBT
15 weekly therapy sessions.
Group TherapyBehavioural
Also called Psychotherapy, Group Psychotherapy
3 months of weekly group therapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Pregnant - Tokophobic | Experimental | Psychoanalysis treatment. Receives: Behavioral: Psychological Treatment |
| 2 - Pregnant - Tokophobic | Experimental | Cognitive-Behavioral treatment. Receives: Behavioral: Psychological Treatment |
| 3 - Non-pregnant - Tokophobic | Experimental | Group Therapy Receives: Behavioral: Group Therapy |
| 4 - Control | No intervention | Pregnant and non-pregnant non-tokophobic women will answer questionnaires. Won't receive therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tokophobia existing and new measures (e.g. Pregnancy anxiety scale, Levin, 1991; Tokophobia subjective scale)
Measured: Pre-treatment, Mid treatment, End of treatment
Secondary outcomes (1)
For pregnant subjects - labor preference, duration and pain medication assessment.
Measured: post-labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for PhobiasStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Miki Bloch, M.D, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801970
- Sponsor's protocol ID
- TASMC-08-MB-0064-CTIL
- Status last verified
- Dec 2008
- First submitted
- 3 Dec 2008
- Last updated
- 4 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Areskog B, Uddenberg N, Kjessler B. Fear of childbirth in late pregnancy. Gynecol Obstet Invest. 1981;12(5):262-6. doi: 10.1159/000299611.
PubMed 7262639Eriksson 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. doi: 10.1016/j.midw.2005.10.002. Epub 2006 Apr 17.
PubMed 16603282Hofberg K, Brockington I. Tokophobia: an unreasoning dread of childbirth. A series of 26 cases. Br J Psychiatry. 2000 Jan;176:83-5. doi: 10.1192/bjp.176.1.83.
PubMed 10789333Hofberg 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. doi: 10.1097/01.grf.0000132527.62504.ca. No abstract available.
PubMed 15326415Alehagen S, Wijma K, Wijma B. Fear during labor. Acta Obstet Gynecol Scand. 2001 Apr;80(4):315-20. doi: 10.1034/j.1600-0412.2001.080004315.x.
PubMed 11264605Eriksson 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. doi: 10.1080/01674820400023275.
PubMed 15962723Johnson R, Slade P. Does fear of childbirth during pregnancy predict emergency caesarean section? BJOG. 2002 Nov;109(11):1213-21. doi: 10.1046/j.1471-0528.2002.01351.x.
PubMed 12452457Olde 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. doi: 10.1016/j.cpr.2005.07.002. Epub 2005 Sep 19.
PubMed 16176853Saisto T, Halmesmaki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201-8.
PubMed 12694113
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fear of Childbirth (Tokophobia) - Etiology, Essence and Clinical Implications
- ClinicalTrials.gov ID
- NCT00801970
- Acronym / sponsor ID
- TASMC-08-MB-0064-CTIL
- Conditions
- Phobias
- Keywords
- Fear of childbirth, Tokophobia, Anxiety, Labor, Pregnancy, Cognitive-behavioral, Psychoanalysis, Group Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 - Pregnant - Tokophobic | Experimental | Behavioral: Psychological TreatmentPsychoanalysis treatment. |
| 2 - Pregnant - Tokophobic | Experimental | Behavioral: Psychological TreatmentCognitive-Behavioral treatment. |
| 3 - Non-pregnant - Tokophobic | Experimental | Behavioral: Group TherapyGroup Therapy |
| 4 - Control | No intervention | –Pregnant and non-pregnant non-tokophobic women will answer questionnaires. Won't receive therapy. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- subjective diagnosis of tokophobia
Key exclusion criteria (9 listed)
- currently undergoing psychological therapy
- Major Depression
- Acute Anxiety
- Psychosis
- Bipolar Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological TreatmentAlso: Psychotherapy, Psychodynamic therapy, Cognitive Behavioral Therapy, CBT15 weekly therapy sessions. | Behavioural | 1 - Pregnant - Tokophobic, 2 - Pregnant - Tokophobic |
| Group TherapyAlso: Psychotherapy, Group Psychotherapy3 months of weekly group therapy sessions. | Behavioural | 3 - Non-pregnant - Tokophobic |
Primary outcome
Tokophobia existing and new measures (e.g. Pregnancy anxiety scale, Levin, 1991; Tokophobia subjective scale)
Time frame: Pre-treatment, Mid treatment, End of treatment
1 secondary outcome
For pregnant subjects - labor preference, duration and pain medication assessment.
Time frame: post-labor
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2008.
- Background: PubMed 7262639Areskog B, Uddenberg N, Kjessler B. Fear of childbirth in late pregnancy. Gynecol Obstet Invest. 1981;12(5):262-6. doi: 10.1159/000299611.
- Background: PubMed 16603282Eriksson 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. doi: 10.1016/j.midw.2005.10.002. Epub 2006 Apr 17.
- Background: PubMed 10789333Hofberg K, Brockington I. Tokophobia: an unreasoning dread of childbirth. A series of 26 cases. Br J Psychiatry. 2000 Jan;176:83-5. doi: 10.1192/bjp.176.1.83.
- Background: PubMed 15326415Hofberg 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. doi: 10.1097/01.grf.0000132527.62504.ca. No abstract available.
- Background: PubMed 11264605Alehagen S, Wijma K, Wijma B. Fear during labor. Acta Obstet Gynecol Scand. 2001 Apr;80(4):315-20. doi: 10.1034/j.1600-0412.2001.080004315.x.
- Background: PubMed 15962723Eriksson 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. doi: 10.1080/01674820400023275.
- Background: PubMed 12452457Johnson R, Slade P. Does fear of childbirth during pregnancy predict emergency caesarean section? BJOG. 2002 Nov;109(11):1213-21. doi: 10.1046/j.1471-0528.2002.01351.x.
- Background: PubMed 16176853Olde 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. doi: 10.1016/j.cpr.2005.07.002. Epub 2005 Sep 19.
- Background: PubMed 12694113Saisto T, Halmesmaki E. Fear of childbirth: a neglected dilemma. Acta Obstet Gynecol Scand. 2003 Mar;82(3):201-8.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miki Bloch, M.D principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological Treatment and Group Therapy in people with Phobias, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shulamit Ben-Itzhak, PhD (972-3-697-4567, shulamit@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tokophobia existing and new measures (e.g. Pregnancy anxiety scale, Levin, 1991; Tokophobia subjective scale) (time frame: Pre-treatment, Mid treatment, End of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801970, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2008.