Condition category
Mental and Behavioural Disorders
Date applied
11/05/2015
Date assigned
20/05/2015
Last edited
18/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Most pregnant women experience some level of anxiety about giving birth during their pregnancy. However, for some women these anxious feelings can develop into tokophobia, a fear of labour and childbirth. Fear of childbirth is considered to be a major factor in women choosing to have a caesarean section for non-medical reasons. Despite the fact that around 10% of women are thought to have a fear of childbirth, tokophobia is not well-recognised by the medical profession and there are no set guidelines on how treat affected patients. As a result, patients may not receive the necessary support from their GP or midwife in the run up to giving birth. The aim of this study is to see how well a short teaching intervention (programme) aimed at the care of women with a fear of childbirth works to improve the experience of patient-doctor interactions during routine appointments. The study will also track how participating women choose to give birth, i.e. by caesarean or vaginal delivery, and how they feel about their childbirth experience overall.

Who can participate?
Pregnant women fluent in Finnish with a referral for fear of childbirth.

What does the study involve?
Participating medical residents are given suggested guidelines on how to care for women fearful of childbirth. Medical residents follow the guidelines during consultations with women who have been referred to them due to their fear of childbirth. After each appointment, participants are asked to complete questionnaires evaluating the success of the appointment. Participating patients’ records are used to assess how women give birth (caesarean delivery versus vaginal birth) and how successful the overall childbirth experience is.

What are the possible benefits and risks of participating?
A potential benefit of participating in this study is improved care for women fearful of childbirth. There are no risks associated with taking part in the study.

Where is the study run from?
University of Helsinki and Helsinki University Hospital (Finland)

When is the study starting and how long is it expected to run for?
November 2014 to March 2016

Who is funding the study?
University of Helsinki and Helsinki University Hospital (Finland)

Who is the main contact?
Dr S Forsell

Trial website

Contact information

Type

Public

Primary contact

Dr Sabrina Forsell

ORCID ID

Contact details

Haartmaninkatu 2
Helsinki
PL 140
Helsinki
00029 HUS
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Assessment of a short teaching intervention effect on care by residents of women with fear of childbirth: a prospective single center study

Acronym

Study hypothesis

A short teaching intervention for residents in treatment of women with fear of childbirth can reduce the anxiety and feelings of helplessnes in both doctor and patient. It can also improve care and thus reduce cesarean section rates and improve the experience of childbirth.

Ethics approval

Ethics Committee for Gynecology and Obstetrics, Pediatrics and Psychiatry at The Hospital District of Helsinki and Uusimaa, 26/03/2015, ref: 93/13/03/03/2015.

Study design

Prospective interventional study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Fear of labour in women giving birth

Intervention

Teaching material covering coping with fear of labour will be given to medical residents at the Helsinki University Hospital, Department of Gynecology and Obstetrics. The teaching material is a short, one-page check list containing brief guidelines and suggestions on how to care for patients with fear of labour during routine appointments. The medical resident will evaluate 10 appointments before and after the intervention.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Grade of anxiety, feelings of helplessness and opinion of overall success of the appointment, of both patient and doctor after the appointment using questionnaires (visual analog scale (VAS)) before and after intervention.

Secondary outcome measures

1. How the women gave birth (cesarean section or vaginal delivery)
2. Satisfaction with the childbirth experience (VAS scale)

Overall trial start date

01/11/2014

Overall trial end date

30/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Pregnant women sent to the maternity clinic with a referral for fear of childbirth, coming for their first appointment with a doctor.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200 patients.

Participant exclusion criteria

Patients without fluency in Finnish.

Recruitment start date

25/05/2015

Recruitment end date

31/12/2015

Locations

Countries of recruitment

Finland

Trial participating centre

University of Helsinki and Helsinki University Hospital
Department of Obstetrics and Gynecology Haartmaninkatu 2 PL 140
Helsinki
00029 HUS
Finland

Sponsor information

Organisation

University of Helsinki and Helsinki University Hospital

Sponsor details

Department of Gynecology and Obstetrics
Haartmaninkatu 2
PL 140
Helsinki
00029 HUS
Finland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

University of Helsinki and Helsinki University Hospital (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Dissemination of the trial results will be started in January 2016. Details of publication will be confirmed at a later date.

Intention to publish date

01/01/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes