Developing and Piloting an Intervention for Multiparas With Fear of Childbirth: a Mixed Methods Study

Sponsor

Tampere University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05766202

Collaborator

Finnish Institute for Health and Welfare (Other), Metropolia University of Applied Sciences (Other), Kanta-Häme Central Hospital (Other)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fear of Childbirth Anxiety Depression	Other: An group intervention for multiparas with fear of childbirth	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Developing and Piloting an Intervention for Multiparas With Fear of Childbirth: a Mixed Methods Study

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change of Fear of Childbirth from baseline to pregnancy week 36 to 8 weeks after birth [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 Outcome Measures

Depression [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.
Anxiety [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.
Childbirth experience [No 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.
Pregnancy related anxiety [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

over 18 years of age
understands finnish language
has self reported fear of childbirth
is a multipara
under 32 weeks pregnant
willingness to participate in the study

Exclusion Criteria:

openly psychotic
at risk of suicide
serious substance abuse problems

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

Principal Investigator: Laura Sandström, MHSc, Tampere University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Laura Sandström, Principal Investigator, Tampere University

ClinicalTrials.gov Identifier:

NCT05766202

Other Study ID Numbers:

ETL-R22124H

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 20, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Laura Sandström, Principal Investigator, Tampere University

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Mar 20, 2023