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

Depression Clinical Trial

— MOTIVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05766202
• Other study ID #: ETL-R22124H
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 27, 2023
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: Tampere University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 19
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Fear of Childbirth

Intervention

Other:
• An group intervention for multiparas with fear of childbirth
The intervention consists of 4 group meetings, three during pregnancy and once after giving birth. It also includes a phone call.

Locations

Country	Name	City	State
Finland	Kanta-Hämeen Keskussairaala	Hämeenlinna

Sponsors (4)

Lead Sponsor	Collaborator
Tampere University	Finnish Institute for Health and Welfare, Kanta-Häme Central Hospital, Metropolia University of Applied Sciences

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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
Secondary	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.