Fear of ChildbirthMOTIVENCT05766202
The MOTIVE (Multiparas Overcoming Childbirth Fear Through Intervention and Empowerement) Feasibility Trial
A study testing An group intervention for multiparas with fear of childbirth in people with Fear of Childbirth and Anxiety, run by Tampere University at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fear of Childbirth, Anxiety, Depression
- What is being tested?
- An group intervention for multiparas with fear of childbirth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteFinland
- Study dates
- 27 Apr 2023to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- openly psychotic
- at risk of suicide
- serious substance abuse problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Fear of Childbirth, Anxiety, Depression
- Being tested
- An group intervention for multiparas with fear of childbirth
- Keywords
- Multipara, Psychoeducation, Prenatal class, Midwife, Psychiatric nurse
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An group intervention for multiparas with fear of childbirthOther
The intervention consists of 4 group meetings, three during pregnancy and once after giving birth. It also includes a phone call.
| Study group | Role | What they receive |
|---|---|---|
| Pilot intervention for multiparas with fear of childbirth | Other | A group intervention with four meetings and one telephone call. Receives: Other: An group intervention for multiparas with fear of childbirth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, week 36 of pregnancy and 8 weeks after birth
Secondary outcomes (5)
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.
Measured: 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.
Measured: Baseline, week 36 of pregnancy and 8 weeks after birth
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.
Measured: Only one measurement point, at 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.
Measured: Baseline and week 36 of pregnancy
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).
Measured: Only one measurement point, at 8-weeks after birth.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start27 Apr 2023
- Primary completion29 May 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University
- Sponsor type
- University, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Metropolia University of Applied Sciences, Kanta-Häme Central Hospital
- Responsible party
- Principal investigator, Laura Sandström, Tampere University
- Investigators
- Laura Sandström, MHSc, Principal investigator, Tampere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766202
- Sponsor's protocol ID
- ETL-R22124H
- Acronym
- MOTIVE
- Status last verified
- Jun 2024
- First submitted
- 1 Mar 2023
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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. 2026 Apr;82(4):3872-3890. doi: 10.1111/jan.17073. Epub 2025 May 23.
PubMed 40405826
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Feasibility of Fear of Childbirth Intervention Aiming to Reduce Fear in Pregnant Multiparas: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT05766202
- Acronym / sponsor ID
- MOTIVE / ETL-R22124H
- Conditions
- Fear of Childbirth, Anxiety, Depression
- Keywords
- Multipara, Psychoeducation, Prenatal class, Midwife, Psychiatric nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Tampere UniversityUniversity, hospital or other
- Collaborators
- Finnish Institute for Health and Welfare, Metropolia University of Applied Sciences, Kanta-Häme Central Hospital
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot intervention for multiparas with fear of childbirth | Other | Other: An group intervention for multiparas with fear of childbirthA group intervention with four meetings and one telephone call. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- over 18 years of age
- understands finnish language
- has self reported fear of childbirth
- is a multipara
- under 35 weeks pregnant
Key exclusion criteria (3 listed)
- openly psychotic
- at risk of suicide
- serious substance abuse problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An group intervention for multiparas with fear of childbirthThe intervention consists of 4 group meetings, three during pregnancy and once after giving birth. It also includes a phone call. | Other | Pilot intervention for multiparas with fear of childbirth |
Primary outcome
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).
5 secondary outcomes
Depression
Time frame: Baseline, week 36 of pregnancy and 8 weeks after birth
Anxiety
Time frame: Baseline, week 36 of pregnancy and 8 weeks after birth
Childbirth experience
Time frame: Only one measurement point, at 8-weeks after birth.
Pregnancy related anxiety
Time frame: Baseline and week 36 of pregnancy
Maternal childbirth experience
Time frame: Only one measurement point, at 8-weeks after birth.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 40405826Sandstrom 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. 2026 Apr;82(4):3872-3890. doi: 10.1111/jan.17073. Epub 2025 May 23.
- Individual participant dataSharing planned: No
Related trials for Fear of Childbirth
Not yet recruiting
Coloring Activity Applied During Labor in Primiparous Pregnant Women and Its Effect on Birth Anxiety and Fear of Childbirth
Fear of Childbirth, Mandala Coloring
Enrolling by invitation
The Effect of Podcast Training on Birth Fear in Couples
Pregnancy, Birth Fear
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruiting
Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
Fear of Childbirth, Pregnancy
Recruiting
Virtual Reality-Enabled Digital Storytelling
Primiparous Pregnant Women
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Sandström, MHSc principal investigator
Tampere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An group intervention for multiparas with fear of childbirth in people with Fear of Childbirth and Anxiety, run by Tampere University at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05766202, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.