Effect of a short teaching intervention on resident's care of women with fear of childbirth
| ISRCTN | ISRCTN15453933 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15453933 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/05/2015
- Registration date
- 20/05/2015
- Last edited
- 03/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Public
Haartmaninkatu 2, Helsinki
PL 140
Helsinki
00029 HUS
Finland
Study information
| Study design | Prospective interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Assessment of a short teaching intervention effect on care by residents of women with fear of childbirth: a prospective single center study |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2014 |
| Completion date | 30/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 patients. |
| Key inclusion criteria | Pregnant women sent to the maternity clinic with a referral for fear of childbirth, coming for their first appointment with a doctor. |
| Key exclusion criteria | Patients without fluency in Finnish. |
| Date of first enrolment | 25/05/2015 |
| Date of final enrolment | 31/12/2015 |
Locations
Countries of recruitment
- Finland
Study participating centre
Haartmaninkatu 2
PL 140
Helsinki
00029 HUS
Finland
Sponsor information
Hospital/treatment centre
Department of Gynecology and Obstetrics
Haartmaninkatu 2
PL 140
Helsinki
00029 HUS
Finland
"ROR" |
https://ror.org/02e8hzf44 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/01/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Editorial Notes
03/05/2017: Trial end date was changed from 30/03/2016 to 30/03/2018.
