Fear of ChildbirthNCT01457482
Art Therapy as Treatment for Fear of Childbirth
A study testing Art Therapy and therapeutic conversations and Therapeutic conversations in people with Fear of Childbirth, run by Helsingborgs Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Fear of Childbirth
- What is being tested?
- Art Therapy and therapeutic conversations and Therapeutic conversations
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteSweden
- Study dates
- May 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women
- Pronounced fear of childbirth
Who cannot join
- Women with a current psychiatric diagnosis
- Women who do not understand Swedish
- Women with a current substance misuse
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Helsingborg Hospital
Helsingborg, Skåne County, 25187
Helén Wahlbeck, Licenced Midwife, +46 42121268, helen.wahlbeck@skane.se
Linda J Kvist, PhD, +46 702361311, linda.kvist@med.lu.se
About this study
Official title: 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.
Read more
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.
- Conditions
- Fear of Childbirth
- Being tested
- Art Therapy and therapeutic conversations, Therapeutic conversations
- Keywords
- Fear, Childbirth, Art therapy, Therapeutic conversations, W-DEQ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art Therapy and therapeutic conversationsOther
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 conversationsOther
Therapeutic conversations with specialist midwives. Number of conversations is determined by the participant.
| Study group | Role | What they receive |
|---|---|---|
| Art therapy group | Experimental | Treatment in this arm consists of five Art Therapy sessions and therapeutic conversations. Receives: Other: Art Therapy and therapeutic conversations |
| Therapeutic conversation group | Active comparator | Treatment by therapeutic conversations only Receives: Other: Therapeutic conversations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores for the Wijma Delivery Expectancy Questionnaire (W-DEQ)
Measured: Change in W-DEQ scores measured at entry to the study (approximately gestational weeks 20 to 31) and again at gestational week 36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsingborgs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helen Wahlbeck, Helsingborgs Hospital
- Investigators
- Linda J Kvist, PhD, Study chair, Lund University, Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01457482
- Sponsor's protocol ID
- 210/422
- Status last verified
- Feb 2012
- First submitted
- 19 Oct 2011
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34231203
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Art Therapy as Treatment for Fear of Childbirth:a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01457482
- Acronym / sponsor ID
- 210/422
- Conditions
- Fear of Childbirth
- Keywords
- Fear, Childbirth, Art therapy, Therapeutic conversations, W-DEQ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Helsingborgs HospitalUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2012 (estimated)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Art therapy group | Experimental | Other: Art Therapy and therapeutic conversationsTreatment in this arm consists of five Art Therapy sessions and therapeutic conversations. |
| Therapeutic conversation group | Active comparator | Other: Therapeutic conversationsTreatment by therapeutic conversations only |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant women
- Pronounced fear of childbirth
Key exclusion criteria (3 listed)
- Women with a current psychiatric diagnosis
- Women who do not understand Swedish
- Women with a current substance misuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Art Therapy and therapeutic conversationsTreatment 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. | Other | Art therapy group |
| Therapeutic conversationsTherapeutic conversations with specialist midwives. Number of conversations is determined by the participant. | Other | Therapeutic conversation group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
- Derived from this study: PubMed 34231203O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda J Kvist, PhD study chair
Lund University, Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy and therapeutic conversations and Therapeutic conversations in people with Fear of Childbirth, run by Helsingborgs Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Helén Wahlbeck, Lic. Midwife (+46 42121268, helen.wahlbeck@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01457482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.