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

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety; Fear of Childbirth
• Intervention / Treatment: Other: An group intervention for multiparas with fear of childbirth

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Hämeenlinna, Finland
    • Kanta-Hämeen Keskussairaala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Pilot intervention for multiparas with fear of childbirth; A group intervention with four meetings and one telephone call.	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.

What is the study measuring?

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
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
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.
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.

Collaborators and Investigators

• Sponsor: Tampere University
• Collaborators: Finnish Institute for Health and Welfare; Kanta-Häme Central Hospital; Metropolia University of Applied Sciences
• Investigators: Principal Investigator: Laura Sandström, MHSc, Tampere University

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Actual): May 29, 2024
• Study Completion (Actual): June 5, 2024

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Psychoeducation; Midwife; Multipara; Prenatal class; Psychiatric nurse
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: ETL-R22124H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No