search
Back to results

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

Primary Purpose

Fear of Childbirth, Anxiety, Depression

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
An group intervention for multiparas with fear of childbirth
Sponsored by
Tampere University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fear of Childbirth focused on measuring Multipara, Psychoeducation, Prenatal class, Midwife, Psychiatric nurse

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Kanta-Hämeen KeskussairaalaRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pilot intervention for multiparas with fear of childbirth

Arm Description

A group intervention with four meetings and one telephone call.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 1, 2023
Last Updated
May 24, 2023
Sponsor
Tampere University
Collaborators
Finnish Institute for Health and Welfare, Metropolia University of Applied Sciences, Kanta-Häme Central Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT05766202
Brief Title
The MOTIVE (Multiparas Overcoming Childbirth Fear Through Intervention and Empowerement) Feasibility Trial
Acronym
MOTIVE
Official Title
The Development and Feasibility of Fear of Childbirth Intervention Aiming to Reduce Fear in Pregnant Multiparas: a Mixed Methods Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University
Collaborators
Finnish Institute for Health and Welfare, Metropolia University of Applied Sciences, Kanta-Häme Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fear of Childbirth, Anxiety, Depression
Keywords
Multipara, Psychoeducation, Prenatal class, Midwife, Psychiatric nurse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pilot intervention for multiparas with fear of childbirth
Arm Type
Other
Arm Description
A group intervention with four meetings and one telephone call.
Intervention Type
Other
Intervention Name(s)
An group intervention for multiparas with fear of childbirth
Intervention Description
The intervention consists of 4 group meetings, three during pregnancy and once after giving birth. It also includes a phone call.
Primary Outcome Measure Information:
Title
Change of Fear of Childbirth from baseline to pregnancy week 36 to 8 weeks after birth
Description
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).
Time Frame
Baseline, week 36 of pregnancy and 8 weeks after birth
Secondary Outcome Measure Information:
Title
Depression
Description
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.
Time Frame
Baseline, week 36 of pregnancy and 8 weeks after birth
Title
Anxiety
Description
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.
Time Frame
Baseline, week 36 of pregnancy and 8 weeks after birth
Title
Childbirth experience
Description
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.
Time Frame
No time frame, only one measurement point, at 8 weeks after birth
Title
Pregnancy related anxiety
Description
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.
Time Frame
Baseline and week 36 of pregnancy

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Sandström, MHSc
Phone
0504649634
Ext
+358
Email
laura.sandstrom@tuni.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Sandström, MHSc
Organizational Affiliation
Tampere University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kanta-Hämeen Keskussairaala
City
Hämeenlinna
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Tervo, YAMK
Email
anne.tervo@omahame.fi

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs