Childbirth Related Fear and Worry During Pregnancy
- Conditions
- Fear of ChildbirthAnxiety
- Registration Number
- NCT03353168
- Lead Sponsor
- Mid Sweden University
- Brief Summary
This is a study of childbirth related anxiety, fear or worry, in which we follow women from mid pregnancy until about 8 months postpartum. Our overall aim is to enhance our understanding of psychological factors contributing to childbirth related fear or worry. Specifically, we wish to investigate
* associations between psychological factors (pain catastrophizing, intolerance of uncertainty, worry beliefs, cognitive avoidance, insomnia, life satisfaction, anxiety- and depressive symptoms, worry parameters, and behavioral avoidance) and childbirth related fear or anxiety during pregnancy
* the impact of childbirth related fear or anxiety and other psychological factors during pregnancy on epidural use during delivery and obstetric outcome variables
* childbirth related fear or anxiety during pregnancy, psychological factors, epidural use, and obstetric outcome variables as predictors of self-reported birth experiences 6-10 months postpartum.
* childbirth related fear or anxiety during pregnancy, psychological factors, epidural use, obstetric outcome variables, and self-reported birth experiences as predictors of childbirth related fear or anxiety 6-10 months postpartum
Women in mid-pregnancy will be recruited at routine check-ups with midwifes working in antenatal health care units in two Swedish regions. After consenting to participate, they will be answering a questionnaire with sociodemographic and obstetric background data, measures of childbirth related fear and anxiety, and measures of psychological variables with a potential relation to childbirth related anxiety. 6-10 months after giving birth they will be contacted again with a postpartum follow-up questionnaire asking questions about the experience of giving birth, postpartum levels of childbirth related fear or anxiety, and thoughts about possible future childbirths. They will also be asked if willing to let the research team include information from their obstetric medical chart (e.g. birth mode and birth interventions, use of analgesia, and complications for the mother and baby) in statistical analyses.
- Detailed Description
Aim and main research questions:
The overall aim with this study investigate psychological factors contributing to childbirth related fear or worry. Specifically, we wish to investigate
* associations between psychological factors (pain catastrophizing, intolerance of uncertainty, worry beliefs, cognitive avoidance, insomnia, life satisfaction, anxiety- and depressive symptoms, worry parameters, and behavioral avoidance) and childbirth related fear or anxiety during pregnancy
* the impact of childbirth related fear or anxiety and other psychological factors during pregnancy on epidural use during delivery and obstetric outcome variables
* childbirth related fear or anxiety during pregnancy, psychological factors, epidural use, and obstetric outcome variables as predictors of self-reported birth experiences 6-10 months postpartum.
* childbirth related fear or anxiety during pregnancy, psychological factors, epidural use, obstetric outcome variables, and self-reported birth experiences as predictors of childbirth related fear or anxiety 6-10 months postpartum
Procedure:
Pregnant women will be recruited by midwives working in antenatal health care units in two Swedish regions; Jämtland/Härjedalen and Örebro County. Recruitment is planned to take place during the first visit following the routine ultrasound examination (normally provided in gestational week 16-20). Women found not eligible will be counted by each antenatal midwife and reported to the project group without any personal identification. Before invited to participate, eligible women will be given oral and written information about the study. Any questions might be asked the midwife directly or via telephone or e-mail to the members of the research group. If accepting participation, each woman will give her written consent. The woman will then receive the first questionnaire. The questionnaire is coded with a unique code for each participant, and does not include any personal identification. It is returned to the research group in a pre-paid envelope. The consent form, also including the unique code of each participant, contact information and personal identification number, is collected by the midwife and later sent to the research group.
In phase two of the study, data will be gathered from two different sources - (a) from the medical birth records of the particular birth, and (b) via a postpartum follow-up questionnaire. These data will be gathered 6-10 months after the planned date of the birth. All women who have returned the first questionnaire and whose address can be confirmed will be contacted by mail and invited to participate in phase two. Letters will be sent, including information about phase two of the project, a postpartum follow-up questionnaire, and a consent form in which the woman can give her written consent for the research team to extract data from the medical birth record. The women are thus free to choose their participation in the two parts of phase 2 separately. The follow-up questionnaire and consent form will returned to the research group by mail, in a pre-paid envelope.
Extraction of medical data: Once consent has been received, obstetric data will be extracted from the medical chart, with help from a midwife at each hospital. The data will be anonymized before leaving the hospital, erasing all personal data such as name and personal identification number, coding the obstetric set of data with the unique participant code number of each woman.
Data and measurements:
The first questionnaire, in mid-pregnancy includes the following sections and scales:
* Sociodemographic background (age, civil status, educational level, occupational status, country of birth)
* Obstetric history/background (pregnancy week, number of fetuses, current pregnancy complications, previous births including birth mode and year)
* Negative experiences in health care
* Preferred mode of birth
* the Fear of Birth Scale, FOBS
* the Wijma Delivery Expectancy/Experience Questionnaire, W-DEQ A
* the Hospital Anxiety and Depression Scale, HADS
* the Pain Catastrophizing Scale, PCS
* the Intolerance of Uncertainty Inventory, part B
* Why Worry II
* the Cognitive Avoidance Questionnaire
* the Insomnia Severity Index, ISI
* the Satisfaction With Life Scale, SWLS
* the Situational Fear of Childbirth, SFC
* items regarding worry frequency, controllability and excess from the GAD-7
* items regarding childbirth specific behavioral avoidance
The postpartum follow-up questionnaire includes:
* Birth information (birth date, birth mode including indication, usage of epidural analgesia)
* the Wijma Delivery Expectancy/Experience Questionnaire, W-DEQ A
* the Fear of Birth Scale, FOBS
* The Childbirth Experience Questionnaire
* Two visual analogue scales regarding the experience of giving birth (vaginally or with Caesarean section) using the anchors "not at all positive" to "very positive" and "not at all negative" to "very negative".
* One visual analogue scale regarding the worst experience of pain during birth, using the anchors "not painful at all" and "worst pain possible".
* One visual analogue scale regarding overall experience of pain during birth, again using the anchors "not painful at all" and "worst pain possible".
* Preferred mode of birth in a future birth
Medical birth data that will be extracted:
* Age of the mother, parity, and gestational week
* Comorbidity
* Obstetric and neonatal outcome variables (see outcome measures)
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 499
- Gestational week 16 or more
- Normal routine ultrasound examination
- Mastery of Swedish language (being able to understand study information and questionnaires)
- For extraction of medical birth records: giving birth in another Swedish region than Jämtland/Härjedalen or Örebro county, or giving birth in another country.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fear of Birth Scale Baseline (around gestational week 20-25) and 6-12 months after expected delivery Two item VAS-scale assessing worry and fear relating to childbirth. The instrument will be used both as a continuous measure of level of fear, and with a cut point of ≥ 60 indicating fear of birth (\< 60 = no fear of birth)
Wijma Delivery Expectancy/Experience Questionnaire Baseline (around gestational week 20-25) and 6-12 months after expected delivery 33 item 6 point Likert scale questionnaire in which the items refer to cognitive and emotional expectations of the forthcoming childbirth. The instrument will be used both as a continuous measure of level of fear, and with a cut point of ≥ 85 indicating fear of childbirth (\< 85 = no fear of childbirth)
- Secondary Outcome Measures
Name Time Method The use of epidural anesthesia during delivery during delivery Use of epidural anesthesia (yes/no) during delivery as reported in obstetric medical chart
Use of analgesics during delivery Use of analgesics other than epidural
Blood loss during delivery Blood loss
Start of contractions during delivery Induced or spontaneous start of contractions
Preferred mode of birth Baseline (around gestational week 20-25) and 6-12 months after expected delivery Preferred mode of birth (vaginal or Caesarean)
Experience of overall pain experience during delivery 6-12 months after expected delivery 100 mm visual analogue scale regarding overall experience of pain during birth, again using the anchors "not painful at all" and "worst pain possible".
Mode of delivery during delivery Vacuum extraction, forceps, Caesarean or vaginal delivery
APGAR score after delivery APGAR at 1, 5 and 10 minutes
Birth weight after delivery Birth weight
Admission to neonatal ward after delivery, within 24 hours Admission to neonatal ward
Experience of giving birth 6-12 months after expected delivery Two 100 mm visual analogue scales regarding the experience of giving birth (vaginally or with Caesarean section) using the anchors "not at all positive" to "very positive" and "not at all negative" to "very negative".
Experience of worst pain during delivery 6-12 months after expected delivery 100 mm visual analogue scale regarding the worst experience of pain during birth, using the anchors "not painful at all" and "worst pain possible".
The Childbirth experience questionnaire 6-12 months after expected delivery 10 items with a 5-point Likert scale ranging from 1 (''completely disagree'') to 5 (''completely agree'') assessing the experience of childbirth, more specifically the distress and pain experienced