The MOTIVE (Multiparas Overcoming Childbirth Fear Through Intervention and Empowerement) Feasibility Trial

Study Overview
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Brief Summary
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The purpose of the study is to develop and pilot an intervention for the treatment of fear of childbirth for multiparas and to evaluate the feasibility of the intervention in the treatment of fear of childbirth in multiparas.

Official Title
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The Development and Feasibility of Fear of Childbirth Intervention Aiming to Reduce Fear in Pregnant Multiparas: a Mixed Methods Study

Conditions
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Fear of Childbirth, Anxiety, Depression

Intervention / Treatment
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* Other: An group intervention for multiparas with fear of childbirth


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years of age understands finnish language has self reported fear of childbirth is a multipara under 32 weeks pregnant willingness to participate in the study Exclusion Criteria: openly psychotic at risk of suicide serious substance abuse problems

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Pilot intervention for multiparas with fear of childbirth<br>A group intervention with four meetings and one telephone call. | Other: An group intervention for multiparas with fear of childbirth<br>* The intervention consists of 4 group meetings, three during pregnancy and once after giving birth. It also includes a phone call.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Fear of Childbirth from baseline to pregnancy week 36 to 8 weeks after birth | The FOBS (Fear of Birth scale) is a validated, self-reported instrument assessing fear of childbirth. Possible scores range from 0 (no fear) to 100 (worst possible fear). Change= (week 36 score - baseline score and 8 weeks after birth - baseline). | Baseline, week 36 of pregnancy and 8 weeks after birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | EPDS (Edinburgh postnatal depression scale) is a validated, self-reported instrument assessing depression.Change= (week 36 score - baseline score and 8 weeks after birth - baseline). Possible scores range from 0 to 30 points. A higher score pointing towards a worse outcome. | Baseline, week 36 of pregnancy and 8 weeks after birth | 
| Anxiety | HADS-A (Hospital Anxiety and depression scale - anxiety) is a validated, self-reported instrument assessing anxiety. Change= (week 36 score - baseline score and 8 weeks after birth - baseline).Possible scores range from 0 to 21 points. A higher score pointing towards a worse outcome. | Baseline, week 36 of pregnancy and 8 weeks after birth | 
| Childbirth experience | CPS (Childbirth perception scale) is a validated, self-reported instrument assessing childbirth experience. Possible scores range from 0 to 48 points. A higher score pointing towards a worse outcome. | Only one measurement point, at 8-weeks after birth. | 
| Pregnancy related anxiety | PRAQ-R2 (Pregnancy Related Anxiety Questionnaire for multiparas) is a validated, self-reported instrument assessing pregnancy related anxiety. Possible scores range from 10 to 50 points. A lower score pointing towards a worse outcome. | Baseline and week 36 of pregnancy | 
| Maternal childbirth experience | VAS (the visual analogue scale) is a ten-point horizontal line with verbal anchors at the extremes of the scale, where higher scores mean better outcomes. The minimum value is 1, and maximum value is 10. VAS has been used to measure the childbirth experience or satisfaction with the childbirth experience in various studies. In addition, VAS has been successfully tested against more detailed measurement instruments, such as the childbirth experience questionnaire (CEQ) and the Wijma Delivery Expectations / Experience Questionnaire (WDEQ-B). | Only one measurement point, at 8-weeks after birth. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multipara, Psychoeducation, Prenatal class, Midwife, Psychiatric nurse