Protocol for a randomised controlled trial of a decision aid for the management of pain in labour and childbirth [ISRCTN52287533]

Making evidence-based decisions in clinical practice is not always straightforward: patients and their healthcare providers may need to weigh up the evidence between several comparable options, the evidence for some treatments may be inconclusive, and the information needs to be tailored to each patient's clinical context and personal preferences [1, 2]. Good medical decision making should take into account the best available evidence, along with patients' preferences and values [3]. However, finding effective and efficient mechanisms for doing this in the clinical setting is a challenge.

To assist patients and their doctors in making informed decisions, information must be unbiased and based on current, high quality, quantitative research evidence. However, patient information materials are often outdated, inaccurate, omit relevant data, fail to give a balanced view and ignore uncertainties and scientific controversies [4, 5]. It is increasingly evident that the provision of patient and provider information alone, even if evidence-based, is not sufficient to influence health outcomes and behaviour [6]. It is only when mechanisms are provided that tailor this information to the individual patient that health outcomes, related to treatment decisions, are positively effected [7]. With this in mind, decision aids are emerging as a promising tool to assist practitioners and their patients in evidence-based decision making [1].

Decision aids are "interventions designed to help people make specific and deliberative choices among options by providing (at minimum) information on the options and outcomes relevant to the person's health status" [1]. Additional strategies may include providing: information on the condition; the probabilities of outcomes tailored to a person's health risk factors; an explicit values clarification exercise; examples of others' decisions; and guidance in the steps of decision making [1]. Decision aids are non-directive in the sense that they do not aim to steer the user towards any one option, but rather to support decision making which is informed, consistent with personal values and acted upon [1]. Decision aids have been found to improve patient knowledge and create more realistic expectations, to reduce decisional conflict (uncertainty about the course of action) and to stimulate patients to be more active in decision making without increasing anxiety [1].

Internationally decision aids have been evaluated in a variety of health and clinical settings. Although their use in pregnancy and birth has only just begun to be explored, this is an area in which consumers are known to want to participate actively in decision making [8]. A survey of 790 Australian women reported a tenfold increase in dissatisfaction among women who did not have an active say in decisions about pregnancy care [8]. Similarly in the UK, women rated the explanation of procedures, including the risks, before they are carried out and involvement in decision making as most important to satisfaction with care [9]. Significantly, neither obstetricians nor midwives appreciated the importance to women of "being told the major risks for each procedure" [9]. Our own survey of pregnant women attending an antenatal clinic found that overwhelmingly women wanted to be involved in decisions regarding their pregnancy care, and this was regardless of age, parity, education or delivery preferences [10].

The pain of labour is a central part of women's experience of childbirth and is a constant feature of antenatal discussion groups [11]. Most women giving birth use some methods of pain relief (pharmacologic and/or non-pharmacologic) during labour. In Australia 92% of primiparas and 71% of multiparas use some analgesic agents for labour analgesia [12]. Significantly, there have been more clinical trials of pharmacological pain relief during labour and childbirth than of any other intervention in the perinatal field [13].

However satisfaction with childbirth is not necessarily contingent upon the absence of pain [14]. Many women are willing to experience pain in childbirth but do not want pain to overwhelm them. The Royal College of Obstetrics and Gynaecology (RCOG) makes the following evidence-based recommendations [15]:

• Continuous caregiver support for a single individual should be available to women in labour

• Midwives must involve women in decisions about analgesia and recognise the value of promoting personal control

• Maternity services should ensure access to written and verbal information on pain relief and should support women in their choices for pain relief

• Maternity services should respect women's wishes to have some control over their pain relief

• Improved public information and data on pain and analgesia

In Australia over 250,000 women give birth annually and the increasing use of epidural analgesia means some 75,000 women have an epidural in labour each year [16]. Among primiparas in NSW, the epidural rate increased from 25% in 1990 to 42% in 2000, but was as high as 74% in hospitals with greater availability of epidurals [12]. Other pharmacologic methods of pain relief for primiparas include 36% opioids and 55% nitrous oxide [12].

Randomised controlled trials have shown epidural analgesia provides the most efficacious pain relief for labour, but the adverse consequences include prolonged labour, restricted mobility, use of oxytocin augmentation and an increased incidence of instrumental delivery [17, 18]. Consequences of instrumental delivery at 6 months postpartum include perineal pain 54%, urinary incontinence 18%, bowel problems 19%, haemorrhoids 36% and sexual problems 39% [19]. Further, the complications of epidurals can include unsatisfactory analgesia, dural-puncture headache, hypotension, nausea/vomiting, fever, localised backache, shivering, pruritis and urinary retention [18].

Although not as effective as epidural, randomised trials show inhalational analgesia (e.g. 50% nitrous oxide in oxygen) and systemic opioid analgesics (e.g. pethidine) can provide modest benefit to some patients during labour or supplement an unsatisfactory epidural [13]. Both these methods can cause nausea, vomiting and dizziness, and additionally opioid side-effects may include orthostatic hypotension, delayed stomach emptying and respiratory depression in the baby [13].

A number of women prefer to avoid pharmacological analgesia if possible [20]. The wish to maintain personal control during labour and birth, the desire to participate fully in the experience, and concerns about untoward effects of medications during labour, are among the factors that influence their attitude [20]. Non-pharmacological methods of pain relief include maternal movement and position changes, superficial heat and cold, immersion in water*, massage, acupuncture/acupressure, transcutaneous electrical nerve stimulation (TENS)*, aromatherapy, attention focussing, hypnosis*, music/audioanalgesia* and continuous caregiver support*. Only a few of these methods (marked*) have been assessed in randomised trials [20‐22]. Only continuous caregiver support resulted in reduced analgesia requirements (and length of labour and the incidence of operative delivery). Although the other interventions trialled did not reduce the use of pharmacologic analgesia, they were well liked by women and had few side effects.

Women report fear of pain in childbirth and often lack complete information on analgesic options prior to labour [11]. For example a Royal Australian and New Zealand College of Obstetrics and Gynaecology brochure on 'Epidural and Spinal Anaesthesia' reports the advantages of epidurals but does not mention any possible adverse outcomes or complications [23]. While written informed consent is required for epidural analgesia, it is not required for other analgesic options. Further, the consent for epidural (covering only the procedure and complications) is obtained by the anaesthetist at the time of the procedure – by which time most women are already distressed [24].

Dickerson stresses the importance of discussing preferences for pain relief before labour begins [13]. A woman's antepartum decision to use pain relief is likely influenced by her cultural background, friends, family, the media, literature and her antenatal caregivers [25]. A survey of Australian women found that antepartum information about analgesia was most commonly derived from hearsay and least commonly from health professionals [26]. Antenatally 82% of women wish to see how labour progresses and only want analgesia when pain becomes severe or intolerable [14]. Antenatal plans for analgesia are strongly associated with use: 96% of women who definitely planned to have an epidural, received one [25].

The management of pain in labour is a clinical decision that fulfils Eddy's criteria for a decision in which patients' values and preferences should be included [2]. The outcomes for analgesia options and, women's preferences for the relative value of benefits compared to risks are variable and could result in decisional conflict. For such a clinical decision, a decision aid would be expected to improve patient knowledge and create realistic expectations, to reduce decisional conflict and to stimulate patients to be more active in decision making without increasing anxiety [1]. Leap has suggested a 'working with pain' framework for managing labour and childbirth in a positive context [11]. This framework which aims to develop an understanding of 'normal pain' as part of the process of labour, rather than the absolute amelioration of pain, has been recommended by the Royal College of Obstetrics and Gynaecology.

During 2003 and 2004, we developed an evidence-based decision aid about the management of pain in labour for women having their first baby. This followed a needs assessment that collected data on the attitudes, preferences and knowledge of nulliparous women who were making plans about pain relief for labour and childbirth. The needs assessment found that women's knowledge of pain relief options was limited and these women would benefit from a decision aid for labour analgesia.

In developing the decision aid we utilised the NHMRC guideline "How to prepare and present information for consumers of health services" [27] and the Ottawa framework established and rigorously tested by the Ottawa Health Decision Center [28]. The decision aid was developed to incorporate a workbook (with and without a complementary audio-component as a compact disc) and worksheet. The workbook highlights key points (similar to a slide presentation) and the audio component connects these points in a narrative format, providing more detail than the workbook. The worksheet is a one-page sheet to be completed by the woman to record her decision making steps, to list any questions she needs answered before deciding, and to encourage her to discuss he plans with her labour care providers. Most importantly, the decision aid is intended to be non-directive in that it does not aim to steer the user towards any one option or increase or decrease intervention rates but rather act as an adjunct to care

The decision aid was designed for women to use at home or in the clinical setting, and takes about 30 minutes to complete. After working through the decision aid, women should take the completed worksheet to their next antenatal appointment to discuss their preferences with their health care provider. The worksheet is also useful for the practitioner, who can see rapidly from it what evidence the patient has considered, what her values and preferences are and which way she is leaning in her preferences for analgesia during labour.

The decision aid was developed, pilot tested and revised with extensive consumer involvement, as outlined in the NHMRC guideline on preparing information for consumers [27]. The content of the decision aid was largely driven by consumers' questions and information needs as determined from the focus groups and from the process of drafting, pilot testing and re-drafting.

A number of draft decision aids (including workbook, audio transcript, and worksheet), were developed and each subjected to pilot testing and revision as we obtained feedback. The process of testing and revising started with the study project group. The next phase included a review by a group of national and international content experts, including decision aid experts, obstetricians, midwives, perinatal epidemiologists, parent educators and psychologists. Once we were convinced that the content was accurate the decision aid was pilot-tested amongst consumers. There were several rounds of consumer review and refinement.

Initially we aimed to compare the Decision Aid (workbook and audio-component) with usual care and counselling however preliminary work led us to alter our original study design. We could find no studies that compared Decision Aids with and without an audio-component. As the audio-component adds considerable complexity to the development and cost of the Decision Aid we decided to have two intervention arms: a Decision Aid with an audio-component and a Decision Aid without an audio-component. Further in pilot testing we found that women in the usual care arm were disappointed to not receive any information. Thus, to minimise refusals and losses to follow-up we decided to issue the women in the control group with a pamphlet called "Pain relief during childbirth – A guide for women" This pamphlet is published by the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, is publicly available and includes information about methods of pain relief during labour [29]. These changes to the study protocol were approved by the institutional ethics committee prior to commencement of the trial.

To compare the relative effectiveness of the Pain Relief for Labour Decision Aid with a pamphlet on women's decisional conflict, knowledge, expectations, satisfaction with decision making and anxiety, and examine its impact on service utilisation and perinatal outcomes (as secondary outcomes).

The primary study hypotheses are:

Use of the Pain Relief for Labour Decision Aid by women expecting their first baby:

The secondary hypotheses of the study are:

Use of the Pain Relief for Labour Decision Aid by women expecting their first baby will not influence:

We will conduct a randomised trial with the following study groups to assess the impact of the decision aid:

Group 1: The pamphlet, "Pain relief during childbirth – A guide for women" [29]

Group 2: Decision aid with an audio-component

Group 3: Decision aid without an audio-component

An Australian tertiary obstetric hospital with a full range of non-drug and anaesthetic options for pain relief in labour. Epidurals are available 24 hours a day from anaesthetic staff designated to labour ward. All forms of antenatal care (clinic, birth centre, private, shared care with a family physician) will be included in the study.

Primiparous women in late pregnancy (≥36 weeks gestation) who are expecting to have a vaginal birth of a single infant will be eligible for the study. Primiparous women were selected because previous pregnancies have a strong impact on decision making and analgesia use in labour [14, 16]. Exclusions include women who will not have any choice about analgesia, for example planned caesarean section (eg breech, placenta praevia, HIV), planned epidural (eg symptomatic heart disease), contraindications to analgesia (e.g drug sensitivities, anticoagulants, thrombocytopaenia). The decision aid was produced in English and designed to be simple and accessible for women with low levels of literacy.

The study procedure draws on the usual schedule of weekly antenatal visits in late pregnancy (Figure 1). We plan a pragmatic approach to assess the decision aid under the conditions most likely to be applied in practice. A research nurse will ask eligible women to participate, explain the trial and obtain informed consent, collect baseline data and randomly allocate women (using telephone randomisation) to one of the study groups. This is only a minor deviation from current practice. As women of child-bearing age are known to be very mobile, participants will be asked to provide alternate contact details (eg friend or relative) to enhance subsequent follow-up. Private obstetricians will be asked to offer participation in the study to their patients. Those interested will be requested to come to the antenatal clinic for recruitment and randomisation. The private obstetrician will provide standard care. Flyers and posters will be prepared to inform women of the study and will be distributed through family physicians and obstetricians as well as the clinics.

Brief baseline data will be collected to assess comparability of the study groups. The baseline assessment will include age, brief socio-demographic data, highest level of education achieved, anxiety as assessed by the state component of the short Spielberger anxiety scale [30], and information sources about labour analgesia.

The aim of the decision aid is to assist preference elicitation, and not to influence the direction of the decision taken. Women in each study group will be given the opportunity to review the intervention they are allocated (decision aid or pamphlet) while in the antenatal clinic and/or to take home, which ever is most convenient. Many women will also want to discuss their preferences with their partner. At the next antenatal visit, women will be contacted by the research nurse to discuss the information materials and any questions they may have had.

As with many obstetric interventions blinding is virtually impossible. The main outcomes of this study are self-reported and the women are clearly not blinded to their treatment allocation. However, we will institute a number of measures aimed at keeping antenatal staff blind to the treatment allocation and preventing contamination of the control group:

• Women will review the decision aid with the research nurse and complete the first questionnaire (primary outcome measures) prior to their next antenatal consultation

• Usual antenatal care providers will be blinded to the exact content and format of the decision aid

• Regular in-service (educational training) for the antenatal care providers to explain the trial protocol and to make clear the potential effect of unmasking or contamination.

• Monitoring decision aid distribution and keeping them locked up and only accessible by the research nurse

• Asking participants not to reveal their treatment allocation, or share their decision aid material with antenatal staff or other women. If participants do not want to keep their decision aid they will be asked to return it.

This work involves the development of a decision aid for the management of pain in labour and childbirth. Women must decide between a range of non-pharmacological and pharmacologic methods of pain relief. However this decision must be made in the context of the likely analgesic effects of each option, the risk of complications and adverse obstetric effects, and maternal preference for relief of pain. There are currently no evidenced based materials available. We therefore expect this project to be beneficial for participating women. A systematic review of decision aids found they improved knowledge without increasing anxiety. Nevertheless we will measure anxiety levels at baseline and follow-up to document any adverse effects. A trained research nurse will interview all women and obtain written informed consent. Women will be encouraged to discuss any concerns/anxiety with the research nurse and/or with their usual antenatal care provider. Women will be reassured that they are able to withdraw from the study at any time with no adverse effects on their pregnancy management. Participation will require women to complete self-report questionnaires during and after pregnancy. Working through the decision aid will take approximately 30 minutes and review of their preferences or outstanding questions will be at a routine antenatal visit. Therefore we do not consider this to be an excessive burden on their time.

The study has been approved by the Central Sydney Area Health Service Ethics Review Committee (Protocol no. X02-0247) and the University of Sydney Human Ethics Committee (Ref No. 3419). This project is funded by a nationally competitive peer-reviewed grant from the Australian National Health and Medical Research Council (No. 253635).

Participants in the trial will be identified by a study number only, with a master code sheet linking names with numbers being held securely and separately from the study data. To ensure that all information is secure, data records will be kept in a secure location at the University of Sydney and accessible only to research staff. As soon as all follow-up is completed the data records will be de-identified. De-identified data will be used for the statistical analysis and all publications will include only aggregated data. The electronic version of the data will be maintained on a computer protected by password. All hard copy patient identifiable data and electronic backup files will be kept in locked cabinets, which are held in a locked room accessed only by security code and limited staff. Data files will be stored for seven years after completion of the project as recommended by the NHMRC. Disposal of identifiable information will be done through the use of designated bags and/or a shredding machine.