- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01457482
Art Therapy as Treatment for Fear of Childbirth
Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Helén Wahlbeck, Lic. Midwife
- Phone Number: +46 42121268
- Email: helen.wahlbeck@skane.se
Study Contact Backup
- Name: Linda J Kvist, PhD
- Phone Number: +46 70 2361311
- Email: linda.kvist@med.lu.se
Study Locations
-
-
Skane
-
Helsingborg, Skane, Sweden, 25187
- Recruiting
- Helsingborg Hospital
-
Contact:
- Helén Wahlbeck, Licenced Midwife
- Phone Number: +46 42121268
- Email: helen.wahlbeck@skane.se
-
Contact:
- Linda J Kvist, PhD
- Phone Number: +46 702361311
- Email: linda.kvist@med.lu.se
-
Principal Investigator:
- Helén Wahlbeck, Lic. Midwife
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Art therapy group
Treatment in this arm consists of five Art Therapy sessions 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
|
Therapeutic conversations with specialist midwives.
Number of conversations is determined by the participant.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Linda J Kvist, PhD, Lund University, Lund, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 210/422
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fear of Childbirth
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University of Las Palmas de Gran CanariaServicio Canario de SaludCompleted
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Marmara UniversityCompleted
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Helsinki University Central HospitalUnknownFear of ChildbirthFinland
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Marmara UniversityNot yet recruitingFear of ChildbirthTurkey
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Istanbul University - Cerrahpasa (IUC)Completed
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Marmara UniversityCompletedFear of ChildbirthTurkey
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Ankara City Hospital BilkentCompleted
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Taipei Medical UniversityCompleted
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Helsinki University Central HospitalCompletedFear of ChildbirthFinland
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Uppsala UniversityUniversity of Melbourne; Mid Sweden UniversityCompleted
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