Fear of ChildbirthNCT03353168
Childbirth Related Fear and Worry During Pregnancy
An observational study of Fear of Childbirth and Anxiety, run by Mid Sweden University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fear of Childbirth, Anxiety
- How many people
- 499 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 30 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A general sample of pregnant Swedish women, recruted at antenatal health care units within primary care.
Who may be able to join
- Gestational week 16 or more
- Normal routine ultrasound examination
- Mastery of Swedish language (being able to understand study information and questionnaires)
Who cannot join
- For extraction of medical birth records: giving birth in another Swedish region than Jämtland/Härjedalen or Örebro county, or giving birth in another country.
About this study
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.
Read the 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)
- Conditions
- Fear of Childbirth, Anxiety
- Keywords
- fear, anxiety, childbirth, pregnancy
- Medical subject headings
- Anxiety Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline (around gestational week 20-25) and 6-12 months after expected delivery
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)
Measured: Baseline (around gestational week 20-25) and 6-12 months after expected delivery
Secondary outcomes (13)
The use of epidural anesthesia during delivery
Use of epidural anesthesia (yes/no) during delivery as reported in obstetric medical chart
Measured: during delivery
Start of contractions
Induced or spontaneous start of contractions
Measured: during delivery
Use of analgesics
Use of analgesics other than epidural
Measured: during delivery
Mode of delivery
Vacuum extraction, forceps, Caesarean or vaginal delivery
Measured: during delivery
Blood loss
Blood loss
Measured: during delivery
APGAR score
APGAR at 1, 5 and 10 minutes
Measured: after delivery
Birth weight
Birth weight
Measured: after delivery
Admission to neonatal ward
Admission to neonatal ward
Measured: after delivery, within 24 hours
Preferred mode of birth
Preferred mode of birth (vaginal or Caesarean)
Measured: Baseline (around gestational week 20-25) and 6-12 months after expected delivery
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".
Measured: 6-12 months after expected delivery
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".
Measured: 6-12 months after expected delivery
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".
Measured: 6-12 months after expected delivery
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
Measured: 6-12 months after expected delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Sep 2015
- Primary completion1 Jan 2018 (estimated)
- Study completion30 Jan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Fear of ChildbirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mid Sweden University
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden, Jämtland County Council, Sweden, Region Örebro County
- Responsible party
- Sponsor
- Investigators
- Johanna Ekdahl, PhD, Principal investigator, Depratment of Psychology, Mid Seden University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353168
- Sponsor's protocol ID
- 2014/372-31Ö
- Status last verified
- Nov 2017
- First submitted
- 19 Jul 2017
- Last updated
- 27 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haines H, Pallant JF, Karlstrom A, Hildingsson I. Cross-cultural comparison of levels of childbirth-related fear in an Australian and Swedish sample. Midwifery. 2011 Aug;27(4):560-7. doi: 10.1016/j.midw.2010.05.004. Epub 2010 Jul 3.
PubMed 20598787Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
PubMed 9638601Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Sullivan, M.J.L., Bishop, S.R., Pivik, J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 7: 524-532, 1995
Carleton RN, Gosselin P, Asmundson GJ. The intolerance of uncertainty index: replication and extension with an English sample. Psychol Assess. 2010 Jun;22(2):396-406. doi: 10.1037/a0019230.
PubMed 20528066Gosselin P, Ladouceur R, Evers A, Laverdiere A, Routhier S, Tremblay-Picard M. Evaluation of intolerance of uncertainty: development and validation of a new self-report measure. J Anxiety Disord. 2008 Dec;22(8):1427-39. doi: 10.1016/j.janxdis.2008.02.005. Epub 2008 Mar 2.
PubMed 18395409Hebert, 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.
Freeston, M. H., Rhéaume, J., Letarte, H., Dugas, M. J., & Ladouceur, R. (1994). Why do people worry? Personality and Individual Differences, 17(6), 791-802. doi:10.1016/0191-8869(94)90048-5
Sexton KA, Dugas MJ. The Cognitive Avoidance Questionnaire: validation of the English translation. J Anxiety Disord. 2008;22(3):355-70. doi: 10.1016/j.janxdis.2007.04.005. Epub 2007 Apr 25.
PubMed 17544253Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
PubMed 11438246Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
PubMed 16367493Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Van den Bussche E, Crombez G, Eccleston C, Sullivan MJ. Why women prefer epidural analgesia during childbirth: the role of beliefs about epidural analgesia and pain catastrophizing. Eur J Pain. 2007 Apr;11(3):275-82. doi: 10.1016/j.ejpain.2006.03.002. Epub 2006 Apr 18.
PubMed 16624602
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childbirth Related Fear and Worry During Pregnancy
- ClinicalTrials.gov ID
- NCT03353168
- Acronym / sponsor ID
- 2014/372-31Ö
- Conditions
- Fear of Childbirth, Anxiety
- Keywords
- fear, anxiety, childbirth, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Mid Sweden UniversityUniversity, hospital or other
- Collaborators
- Örebro University, Sweden, Jämtland County Council, Sweden, Region Örebro County
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- 30 Jan 2018 (estimated)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A general sample of pregnant Swedish women, recruted at antenatal health care units within primary care.
Key inclusion criteria (3 listed)
- Gestational week 16 or more
- Normal routine ultrasound examination
- Mastery of Swedish language (being able to understand study information and questionnaires)
Key exclusion criteria (1 listed)
- For extraction of medical birth records: giving birth in another Swedish region than Jämtland/Härjedalen or Örebro county, or giving birth in another country.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fear of Birth Scale
Time frame: 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
Time frame: 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)
13 secondary outcomes
The use of epidural anesthesia during delivery
Time frame: during delivery
Start of contractions
Time frame: during delivery
Use of analgesics
Time frame: during delivery
Mode of delivery
Time frame: during delivery
Blood loss
Time frame: during delivery
APGAR score
Time frame: after delivery
Birth weight
Time frame: after delivery
Admission to neonatal ward
Time frame: after delivery, within 24 hours
Preferred mode of birth
Time frame: Baseline (around gestational week 20-25) and 6-12 months after expected delivery
Experience of giving birth
Time frame: 6-12 months after expected delivery
Experience of worst pain during delivery
Time frame: 6-12 months after expected delivery
Experience of overall pain experience during delivery
Time frame: 6-12 months after expected delivery
The Childbirth experience questionnaire
Time frame: 6-12 months after expected delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2017.
- Background: PubMed 20598787Haines H, Pallant JF, Karlstrom A, Hildingsson I. Cross-cultural comparison of levels of childbirth-related fear in an Australian and Swedish sample. Midwifery. 2011 Aug;27(4):560-7. doi: 10.1016/j.midw.2010.05.004. Epub 2010 Jul 3.
- Background: PubMed 9638601Wijma K, Wijma B, Zar M. Psychometric aspects of the W-DEQ; a new questionnaire for the measurement of fear of childbirth. J Psychosom Obstet Gynaecol. 1998 Jun;19(2):84-97. doi: 10.3109/01674829809048501.
- Background: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- BackgroundSullivan, M.J.L., Bishop, S.R., Pivik, J. The Pain Catastrophizing Scale: Development and validation. Psychological Assessment 7: 524-532, 1995
- Background: PubMed 20528066Carleton RN, Gosselin P, Asmundson GJ. The intolerance of uncertainty index: replication and extension with an English sample. Psychol Assess. 2010 Jun;22(2):396-406. doi: 10.1037/a0019230.
- Background: PubMed 18395409Gosselin P, Ladouceur R, Evers A, Laverdiere A, Routhier S, Tremblay-Picard M. Evaluation of intolerance of uncertainty: development and validation of a new self-report measure. J Anxiety Disord. 2008 Dec;22(8):1427-39. doi: 10.1016/j.janxdis.2008.02.005. Epub 2008 Mar 2.
- BackgroundHebert, 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.
- BackgroundFreeston, M. H., Rhéaume, J., Letarte, H., Dugas, M. J., & Ladouceur, R. (1994). Why do people worry? Personality and Individual Differences, 17(6), 791-802. doi:10.1016/0191-8869(94)90048-5
- Background: PubMed 17544253Sexton KA, Dugas MJ. The Cognitive Avoidance Questionnaire: validation of the English translation. J Anxiety Disord. 2008;22(3):355-70. doi: 10.1016/j.janxdis.2007.04.005. Epub 2007 Apr 25.
- Background: PubMed 11438246Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
- Background: PubMed 16367493Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Individual participant dataSharing planned: No
Related trials for Fear of Childbirth
Not yet recruiting
Mindfulness Psychoeducation Based on Transtheoretical Model for Fear of Childbirth
Fear of Childbirth, Pregnancy
Recruiting
Virtual Reality-Enabled Digital Storytelling
Primiparous Pregnant Women
Not yet recruiting
Effectiveness of Gestaverso Virtual Reality Birth Preparation in Women With Previous Negative Birth Experiences
Fear of Childbirth, Childbirth-Related Anxiety
Not yet recruiting
THE EFFECT OF 360° VIDEO-ASSISTED TRAINING ON VERTICAL BIRTH POSITIONS IN PRIMIPAROUS WOMEN ON FEAR OF CHILDBIRTH, SELF-EFFICACY IN CHILDBIRTH, SATISFACTION WITH CHILDBIRTH, AND PERINEAL TRAUMA: A RANDOMIZED CONTROLLED TRIAL
Childbirth
Active, not recruiting
The Effects of Positive Birth Experience Sharing and Guided Imagery on Childbirth Self-Efficacy and Fear of Childbirth
Childbirth
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna Ekdahl, PhD principal investigator
Depratment of Psychology, Mid Seden University
Questions about this trial
What is this clinical trial studying?
An observational study of Fear of Childbirth and Anxiety, run by Mid Sweden University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fear of Birth Scale (time frame: Baseline (around gestational week 20-25) and 6-12 months after expected delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353168, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2017.