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Art Therapy as Treatment for Fear of Childbirth

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 February 2012 by Helen Wahlbeck, Helsingborgs Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01457482
First Posted: October 24, 2011
Last Update Posted: February 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Helen Wahlbeck, Helsingborgs Hospital
  Purpose

Earlier research has shown that pregnant women with a pronounced fear of childbirth have a significantly increased risk for birth complications and subsequent psychological trauma. In Sweden and also internationally, women in fear of childbirth are treated in many differing ways. Evidence for best care for these women is lacking. The Art Therapy method is a creative, psycho-therapeutic form of treatment which has been used for several decades within psychiatry. It has recently been seen that the Art Therapy method has positive effects during treatment for crisis reactions.

Recruitment has recently been initiated for a randomized controlled study of Art Therapy for the treatment of fear of childbirth.

The hypothesis for the study is as follows:

H1 = treatment with Art Therapy and therapeutic conversations will result in a decrease in fear of childbirth when compared to treatment by therapeutic conversations only.

The instrument which is to be used for measurement of childbirth fear is the Wijma Delivery Expectancy Questionnaire (W-DEQ). This is a well validated instrument which was developed in Sweden. A power calculation has shown a need for 62 x 2 participants; a total of 124 women.


Condition Intervention
Fear of Childbirth Other: Art Therapy and therapeutic conversations Other: Therapeutic conversations

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Helen Wahlbeck, Helsingborgs Hospital:

Primary Outcome Measures:
  • Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ) [ Time Frame: Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36. ]

Estimated Enrollment: 124
Study Start Date: May 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Art therapy group
Treatment in this arm consists of five Art Therapy sessions and therapeutic conversations.
Other: Art Therapy and therapeutic conversations
Treatment consists of five sessions of Art Therapy given by an authorised Art Therapist and therapeutic conversations with specialist midwives. Number of conversations is determined by the participant.
Active Comparator: Therapeutic conversation group
Treatment by therapeutic conversations only
Other: Therapeutic conversations
Therapeutic conversations with specialist midwives. Number of conversations is determined by the participant.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women
  • Pronounced fear of childbirth

Exclusion Criteria:

  • Women with a current psychiatric diagnosis
  • Women who do not understand Swedish
  • Women with a current substance misuse
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01457482


Contacts
Contact: Helén Wahlbeck, Lic. Midwife +46 42121268 helen.wahlbeck@skane.se
Contact: Linda J Kvist, PhD +46 70 2361311 linda.kvist@med.lu.se

Locations
Sweden
Helsingborg Hospital Recruiting
Helsingborg, Skane, Sweden, 25187
Contact: Helén Wahlbeck, Licenced Midwife    +46 42121268    helen.wahlbeck@skane.se   
Contact: Linda J Kvist, PhD    +46 702361311    linda.kvist@med.lu.se   
Principal Investigator: Helén Wahlbeck, Lic. Midwife         
Sponsors and Collaborators
Helsingborgs Hospital
Investigators
Study Chair: Linda J Kvist, PhD Lund University, Lund, Sweden
  More Information

Responsible Party: Helen Wahlbeck, Lic.Midwife, Art therapist, Helsingborgs Hospital
ClinicalTrials.gov Identifier: NCT01457482     History of Changes
Other Study ID Numbers: 210/422
First Submitted: October 19, 2011
First Posted: October 24, 2011
Last Update Posted: February 14, 2012
Last Verified: February 2012

Keywords provided by Helen Wahlbeck, Helsingborgs Hospital:
Fear
Childbirth
Art therapy
Therapeutic conversations
W-DEQ