Art Therapy as Treatment for Fear of Childbirth

Fear of Childbirth Clinical Trial

Official title:

Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01457482
• Other study ID #: 210/422
• Status: Recruiting
• Phase: N/A
• First received: October 19, 2011
• Last updated: February 13, 2012
• Start date: May 2011

Study information

• Verified date: February 2012
• Source: Helsingborgs Hospital
• Contact: Helén Wahlbeck, Lic. Midwife
• Phone: +46 42121268
• Email: helen.wahlbeck[@]skane.se
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Fear of Childbirth

Intervention

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.
• Therapeutic conversations
Therapeutic conversations with specialist midwives. Number of conversations is determined by the participant.

Locations

Country	Name	City	State
Sweden	Helsingborg Hospital	Helsingborg	Skane

Sponsors (1)

Lead Sponsor	Collaborator
Helsingborgs Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ)		Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.	No