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Completed

NCT Number: NCT05766202

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

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.

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Key information

Conditions

Fear of Childbirth Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kanta-Hämeen Keskussairaala

Hämeenlinna, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change of Fear of Childbirth from baseline to pregnancy week 36 to 8 weeks after birth

    Time frame: 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 outcomes

  1. Depression

    Time frame: 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.

  2. Anxiety

    Time frame: 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.

  3. Childbirth experience

    Time frame: 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.

  4. Pregnancy related anxiety

    Time frame: 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.

  5. Maternal childbirth experience

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MOTIVE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 13, 2023
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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