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

NCT05766202 | Completed

• 1 other identifier: ETL-R22124H
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear of Childbirth; Anxiety; Depression

Keywords

Multipara; Psychoeducation; Prenatal class; Midwife; Psychiatric nurse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Depression

  Baseline, week 36 of pregnancy and 8 weeks after birth

• Anxiety

  Baseline, week 36 of pregnancy and 8 weeks after birth

• Childbirth experience

  Only one measurement point, at 8-weeks after birth.

• Pregnancy related anxiety

  Baseline and week 36 of pregnancy

• Maternal childbirth experience

  Only one measurement point, at 8-weeks after birth.

Study Arms (1)

Pilot intervention for multiparas with fear of childbirth

OTHER

A group intervention with four meetings and one telephone call.

Other: An group intervention for multiparas with fear of childbirth

Interventions

An group intervention for multiparas with fear of childbirth OTHER

The intervention consists of 4 group meetings, three during pregnancy and once after giving birth. It also includes a phone call.

Pilot intervention for multiparas with fear of childbirth

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tampere University: lead
• Finnish Institute for Health and Welfare: collaborator
• Metropolia University of Applied Sciences: collaborator
• Kanta-Häme Central Hospital: collaborator

Study Sites (1)

Kanta-Hämeen Keskussairaala

Hämeenlinna, Finland

Location

Related Publications (1)

• Sandstrom L, Kaunonen M, Huhtala H, Aho AL. Evaluating a Group-Based Intervention Addressing Fear of Childbirth in Multiparous Pregnant Women: A Mixed Methods Feasibility Study. J Adv Nurs. 2025 May 23. doi: 10.1111/jan.17073. Online ahead of print.

  PMID: 40405826 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Laura Sandström, MHSc

  Tampere University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: April 27, 2023
• Primary Completion: May 29, 2024
• Study Completion: June 5, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)