Art Therapy as Treatment for Fear of Childbirth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Helsingborgs Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Helen Wahlbeck, Helsingborgs Hospital
ClinicalTrials.gov Identifier:
NCT01457482
First received: October 19, 2011
Last updated: February 13, 2012
Last verified: February 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study

Further study details as provided by 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. ] [ Designated as safety issue: No ]

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

Genders 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
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: 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

No publications provided

Responsible Party: Helen Wahlbeck, Lic.Midwife, Art therapist, Helsingborgs Hospital
ClinicalTrials.gov Identifier: NCT01457482     History of Changes
Other Study ID Numbers: 210/422
Study First Received: October 19, 2011
Last Updated: February 13, 2012
Health Authority: Sweden: Swedish National Council on Medical Ethics

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

ClinicalTrials.gov processed this record on October 20, 2014