Anxiety Clinical Trial
Official title:
Childbirth Related Fear and Worry During Pregnancy
Verified date | November 2017 |
Source | Mid Sweden University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 499 |
Est. completion date | January 30, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Gestational week 16 or more - Normal routine ultrasound examination - Mastery of Swedish language (being able to understand study information and questionnaires) Exclusion Criteria: - For extraction of medical birth records: giving birth in another Swedish region than Jämtland/Härjedalen or Örebro county, or giving birth in another country. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Mid Sweden University | Jämtland County Council, Sweden, Örebro University, Sweden, Region Örebro County |
Bastien CH, Vallières A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. — View Citation
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Hebert, E. A., Dugas, M. J., Tulloch, T. G., & Holowka, D. W. (2014). Positive beliefs about worry: A psychometric evaluation of the Why Worry-II. Personality and Individual Differences, 56, 3-8.
Sexton KA, Dugas MJ. The Cognitive Avoidance Questionnaire: validation of the English translation. J Anxiety Disord. 2008;22(3):355-70. Epub 2007 Apr 25. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fear of Birth Scale | 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) | Baseline (around gestational week 20-25) and 6-12 months after expected delivery | |
Primary | Wijma Delivery Expectancy/Experience Questionnaire | 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) | Baseline (around gestational week 20-25) and 6-12 months after expected delivery | |
Secondary | The use of epidural anesthesia during delivery | Use of epidural anesthesia (yes/no) during delivery as reported in obstetric medical chart | during delivery | |
Secondary | Start of contractions | Induced or spontaneous start of contractions | during delivery | |
Secondary | Use of analgesics | Use of analgesics other than epidural | during delivery | |
Secondary | Mode of delivery | Vacuum extraction, forceps, Caesarean or vaginal delivery | during delivery | |
Secondary | Blood loss | Blood loss | during delivery | |
Secondary | APGAR score | APGAR at 1, 5 and 10 minutes | after delivery | |
Secondary | Birth weight | Birth weight | after delivery | |
Secondary | Admission to neonatal ward | Admission to neonatal ward | after delivery, within 24 hours | |
Secondary | Preferred mode of birth | Preferred mode of birth (vaginal or Caesarean) | Baseline (around gestational week 20-25) and 6-12 months after expected delivery | |
Secondary | Experience of giving birth | 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". | 6-12 months after expected delivery | |
Secondary | Experience of worst pain during 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". | 6-12 months after expected delivery | |
Secondary | Experience of overall pain experience during 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". | 6-12 months after expected delivery | |
Secondary | The Childbirth experience questionnaire | 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 | 6-12 months after expected delivery |
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