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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05766202
Acronym
MOTIVE
Enrollment
19
Registered
2023-03-13
Start date
2023-04-27
Completion date
2024-06-05
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Fear of Childbirth

Keywords

Multipara, Psychoeducation, Prenatal class, Midwife, Psychiatric nurse

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.

Interventions

OTHERAn 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.

Sponsors

Finnish Institute for Health and Welfare
CollaboratorOTHER_GOV
Metropolia University of Applied Sciences
CollaboratorOTHER
Kanta-Häme Central Hospital
CollaboratorOTHER_GOV
Tampere University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of Fear of Childbirth from baseline to pregnancy week 36 to 8 weeks after birthBaseline, week 36 of pregnancy and 8 weeks after birthThe 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

MeasureTime frameDescription
DepressionBaseline, week 36 of pregnancy and 8 weeks after birthEPDS (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.
AnxietyBaseline, week 36 of pregnancy and 8 weeks after birthHADS-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.
Childbirth experienceOnly 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.
Pregnancy related anxietyBaseline and week 36 of pregnancyPRAQ-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 experienceOnly 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).

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026