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A new scale for fear of childbirth: the Fear of Childbirth Questionnaire (FCQ)

ABSTRACT Objective To create a clear and acceptable measure of fear of childbirth with satisfactory content validity for use with English-speaking women in the UK. Background Fear of childbirth (FOC) can have a significant impact on a woman’s view of her pregnancy, birth and her recovery post birth. Early identification is paramount to ensure that women’s needs are recognised so that appropriately tailored care can be provided in pregnancy. Availability of reliable and valid measures to assess FOC in an English-speaking population are sparse, mainly due to issues with definitions of FOC or cultural sensitivity after translation. Recent research from phase one of the Fear of Childbirth study (FOCUS), has established key elements for FOC in an English-speaking UK population, and allows for a culturally sensitive measure of FOC to be developed. The aim was to ensure inclusion of all ten FOC elements and to attend to guidance from women in phase two of the FOCUS study about what would ensure clarity and acceptability. Method A multidisciplinary team developed items in accordance with FOCUS. The measure was then piloted with one reviewer and further refined by the team of perinatal researchers. Results The FCQ is a new 20-item fear of childbirth questionnaire, which has been developed and is grounded in fears reported by women in the UK. Conclusion A new tool to measure FOC in an English-speaking UK population with good content validity has undergone a preliminary phase of development and now needs testing for reliability and other forms of validity.


Introduction
For many, the perinatal journey is a time of excitement and hope, but for some women it can be a negative and frightening experience. Of the range of mental health challenges a women might experience in the perinatal period, anxiety-related disorders have the highest prevalence (Dennis et al., 2017;Heron et al., 2004;Wallwiener et al., 2019). A very specific focus of anxiety can be fear of childbirth (FOC).
Fear of childbirth encompasses severe fear, anxiety or concern specifically in relation to childbirth (Saisto & Halmesmäki, 2003). When severe, fears are indicative of a phobia of giving birth; termed tokophobia (Zar et al., 2001). A distinction is made between primary tokophobia (occurring with no prior experience of giving birth) and secondary tokophobia (occurring following the experience of a prior birth; Saisto & Halmesmäki, 2003). It is estimated that approximately one in seven women experience severe FOC (O'Connell et al., 2017); however, this proportion is uncertain given limitations in existing measurement tools and methods of inferring severity (Jomeen et al., 2021;Slade et al., 2020).
A standardised measure of fear of childbirth has yet to be consistently utilised in the UK. There is a consensus that use of such an instrument could be beneficial (Jomeen et al., 2021;Nilsson et al., 2018); however, currently the only recommendation by the National Institute of Clinical Excellence (NICE) for the recognition of mental health difficulties relating to anxiety is that healthcare staff consider using the 2-item Generalised Anxiety Disorder Scale (GAD-2;NICE, 2014). The GAD-2 reviews women's feelings over the past two weeks and questions how often they have been bothered by feeling nervous, anxious or on edge or bothered by not being able to stop or control worrying. The GAD-2 has good screening properties within the general population (Löwe et al., 2008), however the utility of generalised anxiety measures to measure specific pregnancy and childbirthrelated fears has increasingly come under question (Alderdice et al., 2012;Huizink et al., 2004). Although the GAD-2 might be well placed to open discussions about pregnancyrelated anxiety, it is unlikely to capture the range of pregnancy or childbirth-related fears that women report to have (Nath et al., 2020).
Many healthcare professionals use additional measures to try to gain further meaningful information about specific pregnancy or birth-related fears. The limitations of many of these measures have been highlighted, in terms of their utility and acceptability for English speaking UK women (Jomeen et al., 2021;Nilsson et al., 2018;Richens et al., 2018;Slade et al., 2020). The appropriate development of valid UK measures has been hindered by issues like the general lack of clarity around the definition of FOC in the UK (Richens et al., 2018;Rondung et al., 2016) and the cultural sensitivity of otherwise reliable and valid measures after being translated into English (Johnson & Slade, 2002;Toohill et al., 2014).
Attitudes towards childbirth are influenced by cultural norms and healthcare patterns and in some respects it is unsurprising that both the level and content of fear differs between countries. A study involving six European countries, not including the UK, using the Wijma Delivery Expectancy-Experience Questionnaire Version A (WDEQ-A; Wijma et al., 1998) reported a consistent 6-item factor structure of scores across each population (Lukasse et al., 2014). Fears related to a lack of self-efficacy, loneliness, negative appraisals, lack of positive anticipation, fear, and concern for the child. However, the authors note differences in the levels of fears reported within each dimension between countries (Lukasse et al., 2014). A UK study, also using the WDEQ-A, found that scores were best represented by a four-factor version of the tool (fear, lack of positive anticipation, isolation and riskiness), indicating differences in the underlying dimensions of fears reported (Johnson & Slade, 2002). Similarly, differences in fear of childbirth have been identified between Australian and Swedish populations (Haines et al., 2011), and between populations from Israel and Norway (Preis et al., 2018). It is unclear how far these differences represent real differences in the rates, or how far they are a feature of issues relating to content validity and clarity of the measures used. Findings do indicate that, before widespread use, the accuracy and acceptability of a measurement tool requires specific exploration and development for the population for whom it is intended.
The Fear of Childbirth Study (FOCUS) was set up to establish in phase one a clear definition of the constituent elements of FOC for English speaking women in the UK (Slade et al., 2019). A meta-synthesis was conducted to identify key aspects of FOC as reported by women in the wider qualitative literature (Sheen & Slade, 2018). In addition, interviews were conducted with pregnant women (n = 10) who reported FOC, and consultant midwives (n = 13) experienced in providing supporting women in this context, to identify the key elements of FOC. Findings from the meta-synthesis and interviews were integrated, and fears identified in at least 2 of these three sources (and where at least one of these sources represented women's voices) were retained. This enabled the development of a construct for FOC, incorporating the breadth of fears as reported by women.
Ten key elements were identified, reflecting views of both primiparous and multiparous women (Slade et al., 2019): (1) Fear of not knowing and not being able to plan for the unpredictable; for primiparous women, this included not knowing how to manage giving birth, and for multiparous women this included an understanding of how unpredictable birth can be (2) Fear of harm or stress to the baby; this involved a fear of the baby becoming distress during labour and birth and a fear of potential harm (3) Fear of my inability to cope with the pain; this included fears relating to coping with pain and also receiving adequate pain relief (4) Fear of harm to self in labour and postnatally; this included fear of experiencing harm or feeling unsafe during labour (5) Fear of being 'done' to; this involved fears about interventions or procedures being conducted, without women being actively involved in the decision-making process (6) Fear of not having a voice in decision making; this involved fears about having preferences 'missed' during labour and birth, and not feeling listened to (7) Fear of being abandoned and alone; this involved fear about being physically alone, for example, without a birth partner or midwife, but also a sense of feeling psychologically alone (8) Fear of my body's ability to give birth; this encompassed fears relating to physically being able to give birth, including concerns about women's own body size, their baby's size or positioning and their own physical strength to cope through labour and birth (9) Fear of internal loss of control; this included fears about losing self-control throughout labour an birth (10) Terrified of birth and not knowing why; this final element encompassed a general feeling of fear, without a specific reason or cause Any measure needs to take into account women's preferences for length and style in order to maximise appropriate usage. Phase 2 of the FOCUS study (Slade et al., 2020) aimed to consider all relevant existing measures in terms of their content validity, practicality of completing the questionnaire (ease of completion, structural properties of the measure) and whether they met acceptability criteria in terms of phraseology, clarity, length and presentation. Cognitive interviews were conducted with pregnant women to review four of the most commonly used FOC measures in the UK; the WDEQ-A (Wijma et al., 1998), the Oxford Worries about Labour Scale (OWLS; Redshaw et al., 2009), the Slade-Pais Expectancy of Childbirth Scale (SPECS; Slade et al., 2016) and the Fear of Birth Scale (FOBS; Haines et al., 2011).
Findings highlighted issues with ambiguity of items in some of the scales reviewed. On the WDEQ-A, three items were viewed as difficult to understand and seven were viewed as ambiguous. On the OWLS and the SPECS, only 1 items on each scale was viewed as ambiguous, and for the FOBS there were no issues at all about understandability . In terms of acceptability, the phraseology of the OWLS was viewed positively; as women felt that the language used was easy to identify with. Two items in the WDEQ-A and one item in the SPECS raised acceptability concerns, due to perceived negative phraseology (Slade et al., 2020).
In terms of presentation and ease of use, the OWLS was positively viewed by women due to the number of items and ease of completion although it was recognised that the content of items within this measurement tool favoured assessment of worries related to the physical aspects of labour rather than any emotional components. In comparison, the WDEQ-A was felt to provide a detailed assessment of FOC, and some liked this thoroughness. However, others felt that the scale was too long, and that items favoured assessment of the emotional aspects of labour and not the physical. It was noted that both the SPECS and OWLS did not ask about women's safety, and may not be sufficiently detailed to capture the range of different fears experienced by women. The FOBS was viewed as very easy to complete, but there were concerns that the scale did not provide enough detail on the nature of fears experienced.
Items from each of the scales were reviewed in conjunction with the ten key elements of fear of childbirth. None of the existing measures included items that asked about each element of FOC. Issues in the existing scales therefore extended beyond acceptability and included inadequate content validity (Slade et al., 2020).
Furthermore, a recent empirical comparison of the FOBS, W-DEQ, SPECS and OWLS highlighted significant limitations in symptom overlap, indicating that each tool captures measurement of different aspects of FOC (Martin et al., 2020). It is clear that, for UK women, current measures have significant shortcomings and there is a need for a measure with appropriate content validity, clarity, and acceptability.

Aim of the current study
To complete the preliminary phases of developing a new scale to measure FOC for use with English-speaking women based in the United Kingdom, which fulfils content validity and acceptability standards, and which reflects each of the ten key elements of fear.

Ethical approval
Ethical approval was obtained from the University of Liverpool (15/NW/0922) and the study was sponsored by University of Liverpool (UoL00177).

Developing the Fear of Childbirth Questionnaire (FCQ)
A multidisciplinary research team consisting of two clinical psychologists, a research psychologist and a consultant midwife generated questions that utilised the words expressed by the women themselves in phase one of the FOCUS study (Slade et al., 2019). Through discussion, two items for each domain were selected by the team based on fulfiling requirements of mapping closely to women's own wording and being clearly within the thematic domain. In line with women's preferences, all questions were checked for fear-inducing words with particular attention paid to ensure positive phrasing where possible. Items that could not be worded positively were situated in the middle of the questionnaire, to ensure they are surrounded by more positive items. Table 1 shows the list of items and the corresponding element of FOC.
Findings obtained from phase two of FOCUS were used to shape the FCQ in terms of the practicalities and acceptability of the measure (Slade et al., 2020). In terms of practicality, the measure needed to be quick and easy to rate. A 5 rather than 4-point scale was preferred, with higher scores (for stronger feelings) on the right hand side. Women had also expressed a preference for inclusion of an open-ended question at the end of the questionnaire enquiring about whether a woman would like further support to be provided. They also reported preferring to be asked about their current feelings, for items to be positively framed and sensitively worded (e.g. avoidance of words such as risk, fail, dangerous), and for the measure to be accessible in terms of readability. Items enquiring about both physical and emotional worries were also wanted.
To establish the frequency and intensity of FOC, three further items were included at the end of the scale. Firstly, 'Have any of the points above really bothered you over the past 2 weeks'. If 'yes' women are asked, 'how much and how often have they bothered you?' These questions are graded using a 5-point Likert scale where a higher score indicates a greater degree of distress. Then women are asked whether they would like support. The measure was constructed using a 'point' scale rather than a sliding scale where stronger feelings are represented by a higher number.

Review of the FCQ items
A service user further reviewed the FCQ for clarity and acceptability and provided feedback. The positive wording and balance between 'worries' and 'feeling confident' was favourably viewed. The two main suggestions for consideration from the reviewer were (1) to move 'I am terrified of giving birth and not sure why' to be the first question. The reviewer highlighted that although the questionnaire would open with a 'worry' it is not a frightening question. The team considered this feedback but were concerned that opening with this question might make a woman feel like they are contradicting themselves over the next few questions if they give more detail around specifics fears, therefore this was not implemented; (2) The reviewer suggested that 'My baby will be stressed' sounded like the baby will be worried coming out rather than distressed and harmed during labour and birth, therefore the team agreed to change the wording to 'My baby will be distressed' rather than stressed.
The amended questionnaire was reviewed again by the perinatal research team. Further refinements were made to reduce the response scale from a 5-point to a 4-point scale (thus removing the neither agree or disagree option) to force a choice of orientation, and moving item number 18 ('I am confident staff will always respect my wishes') earlier on in the scale to create more positivity at the beginning of the questionnaire.

Assessment of readability
Following the amendments to the questionnaire, the reading level of the FCQ was reviewed. The FCQ has a Flesch-Kincaid Grade Level of 5.1, which makes it suitable even for readers who are new to reading and a Flesch Reading ease level of 88% (the closer the score to 100% the easier it is to read), which suggests that the questionnaire is easy to read and highly acceptable for a wide range of reading abilities.

Results
The FCQ is shown in Table 2.

Discussion
The FCQ is measure where the design process ensures strong content validity. It includes both physical and emotional fears. It is a user-friendly tool developed to meet women's needs in terms of clarity and accessibility. In line with women's preferences, the questionnaire has been designed to be quick, easy to complete, and based on how a woman currently feels rather than how she thinks she will feel in the future. It uses language that is relevant and meaningful to women without unnecessary complexity and is suitable for a wide range of literacy levels. The questionnaire also in line with women's preferences where possible and endeavours to use sensitive and positive language to protect against further distress whilst completing. (3) 1 I feel fine about my labour and giving birth to my baby 2 I worry my labour or birth will not go to plan 3 I am confident that staff will always respect my wishes 4 I am worried about the long-term effects that labour or birth could have on my body 5 I am confident I will be able to cope with the pain 6 I am worried that my baby will be harmed during labour and birth 7 I worry I will lose control of myself during labour 8 I am confident my body can give birth to my baby 9 I worry I will not have a voice in decision making during labour 10 I am confident I am emotionally strong enough to cope with labour and birth 11 I worry that labour is unpredictable 12 I am worried about things being 'done' to me during labour and birth 13 I am worried I will be harmed during labour 14 I am confident that staff will be there when I need them 15 I worry that my baby will feel distressed during labour and birth 16 I worry about having unpleasant procedures during labour and birth 17 I am confident I will get the pain relief I want 18 I worry about being left alone, without my chosen birth partner, during labour 19 I am worried about labour and birth and I don't know why 20 I am confident my body will work well during labour and birth Have any of the points above really bothered you over the past 2 weeks (please circle)?

Yes No
If no, thank you for completing this questionnaire If yes, please answer the next three questions (please circle):

Yes No
The items in the FCQ have been generated from accounts from women themselves to ensure high content validity, in contrast to some of the other measures that are currently used in the UK (Wackerbarth et al., 2002). All 20 items in the FCQ have already been identified as essential components for FOC within the literature, but have not been integrated into one screening tool until the FCQ. There are consistent reports of women's fears for their own wellbeing and that of their baby (Klabbers et al., 2020;Stoll & Hall, 2013), fear of pain (Eriksson et al., 2006;Saisto & Halmesmäki, 2003), fear of procedures within labour (Szeverényi et al., 1998), fear of not knowing and not being able to plan for the unpredictable (Zar et al., 2001), as well as mistrust of how staff will treat them (Saisto & Halmesmäki, 2003), fear of internal loss of control (Melender, 2002;Sheen & Slade, 2018) and fear of their body's ability to give birth and being terrified of birth and not knowing why (Sheen & Slade, 2018).
This meets many of the identified drawbacks of existing scales (Slade et al., 2020). Clearly only the preliminary phase of development has been completed. However, because of the obvious inadequacies of existing scales often in routine use and the urgent salience of the issue of FOC in women's care it was felt appropriate to publicly share this material at the earliest possible stage and prior to further phases of psychometric testing. Clearly, the FCQ now requires reliability testing for both internal consistency and testretest reliability. Examination of underlying dimensions and unidimensionality is required. Further forms of validity testing are required in terms of both construct, criterion, and predictive validity. Use of the FCQ against clinical interview is required to provide an opportunity to develop sensitivity and specificity guidance and develop clinically relevant threshold scores.
If satisfactory psychometric properties are confirmed, as the FCQ provides identification of the primary areas of concern, it could be tested as a tool as a second step following a very brief measure such as the Fear of Birth (FOBS) scale (Haines et al., 2011). Use of the FCQ in routine antenatal practice would provide a valuable opportunity to initiate discussions around FOC between women and care providers. This could facilitate a clinically useful system of identification of women for whom an offer of intervention may be of value at the same time as guiding and informing the focus of that intervention.

Limitations
Although the design of the FCQ is based on women's accounts and constructs of FOC, the validity and reliability would need to be verified within an empirical study.

Relevance to clinical practice
The FCQ is a culturally appropriate tool for UK based, English speaking women, relevant and acceptable for women who have fears of childbirth. If planned future psychometric testing confirm reliability and validity of the tool, it should provide a way for healthcare professionals and women to initiate meaningful discussions about fears. Given that this is a simple and straightforward questionnaire, integration of use in antenatal care should be easily facilitated. If services can move to accurately identify women who are highly fearful of childbirth, then this provides potential to activate an effective pathway of care early in the pregnancy journey, to ensure women are appropriately supported at every stage. This is particularly relevant at the current time when new maternal mental health services (which will include provision for women with fear of childbirth) are being developed in England.

Conclusion
There is an important need for a more systematic approach to the identification of fear of childbirth in women in the UK and it is to be hoped that the FCQ contributes to that process. Future work needs to establish the test-retest reliability of the FCQ, construct validity with anxiety and content validity to ensure this is an appropriate measure of FOC.