NCT01457482

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

1.6 years

First QC Date

October 19, 2011

Last Update Submit

February 13, 2012

Conditions

Keywords

FearChildbirthArt therapyTherapeutic conversationsW-DEQ

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Art therapy group

EXPERIMENTAL

Treatment in this arm consists of five Art Therapy sessions and therapeutic conversations.

Other: Art Therapy and therapeutic conversations

Therapeutic conversation group

ACTIVE COMPARATOR

Treatment by therapeutic conversations only

Other: Therapeutic conversations

Interventions

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.

Art therapy group

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

Therapeutic conversation group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women
  • Pronounced fear of childbirth

You may not qualify if:

  • Women with a current psychiatric diagnosis
  • Women who do not understand Swedish
  • Women with a current substance misuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsingborg Hospital

Helsingborg, Skåne County, 25187, Sweden

RECRUITING

Related Publications (1)

  • O'Connell MA, Khashan AS, Leahy-Warren P, Stewart F, O'Neill SM. Interventions for fear of childbirth including tocophobia. Cochrane Database Syst Rev. 2021 Jul 7;7(7):CD013321. doi: 10.1002/14651858.CD013321.pub2.

MeSH Terms

Interventions

Art Therapy

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Linda J Kvist, PhD

    Lund University, Lund, Sweden

    STUDY CHAIR

Central Study Contacts

Helén Wahlbeck, Lic. Midwife

CONTACT

Linda J Kvist, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lic.Midwife, Art therapist

Study Record Dates

First Submitted

October 19, 2011

First Posted

October 24, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations