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

Not Applicable

Completed

• Conditions: Anxiety; Depression; Fear of Childbirth
• Interventions: Other: An group intervention for multiparas with fear of childbirth

• Registration Number: NCT05766202
• Lead Sponsor: Tampere University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-13
• Study Start: 2023-04-27
• Primary Completion: 2024-05-29
• Status Verified: 2024-06
• Study Completion: 2024-06-05
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• over 18 years of age
• understands finnish language
• has self reported fear of childbirth
• is a multipara
• under 35 weeks pregnant
• willingness to participate in the study

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Exclusion Criteria

• openly psychotic
• at risk of suicide
• serious substance abuse problems

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pilot intervention for multiparas with fear of childbirth	An group intervention for multiparas with fear of childbirth	A group intervention with four meetings and one telephone call.

Primary Outcome Measures

Name	Time	Method
Change of Fear of Childbirth from baseline to pregnancy week 36 to 8 weeks after birth	Baseline, week 36 of pregnancy and 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).

Secondary Outcome Measures

Name	Time	Method
Anxiety	Baseline, week 36 of pregnancy and 8 weeks after birth	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.
Pregnancy related anxiety	Baseline and week 36 of pregnancy	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.
Maternal childbirth experience	Only one measurement point, at 8-weeks after birth.	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).
Depression	Baseline, week 36 of pregnancy and 8 weeks after birth	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.
Childbirth experience	Only one measurement point, at 8-weeks after birth.	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.

Trial Locations

Locations (1)

Kanta-Hämeen Keskussairaala; 🇫🇮 Hämeenlinna, Finland