The effect of different preparation information on side effects following intravenous iron infusion

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In patients with a low haemoglobin (Hb) for whom oral iron is considered unsuitable/has been unsuccessful, intravenous (IV) iron is used. Indications for IV iron infusion include malabsorption, continuing blood loss, poor adherence, or intolerance. Iron infusions are also sometimes offered in a preoperative setting to patients with iron deficiency anaemia. At Auckland City Hospital, IV iron is administered as a single dose infusion taking approximately 15minutes. Immunological hypersensitivity reactions to IV iron are rare, however unwanted side effects (e.g. flushing, joint/muscle pains, headache and dizziness) are commonly reported by patients (Rampton et al., 2014). In a healthcare context, the nocebo effect can be defined as the experience of symptoms, that are induced by the patient’s own negative expectations and/or by negative suggestions from clinical staff (Hauser, Hansen, & Enck, 2012). In a recent study we found that an explanation of the nocebo effect as a symptomatic experience influenced by negative expectations was effective in significantly reducing symptom reporting (Crichton & Petrie, 2015). In this study we are investigating whether the nocebo effect has relevance to clinical medicine by examining whether changing standard verbal preparation information to include an explanation of the nocebo effect can reduce side effect reporting after IV iron infusion. Reductions in side effect reporting may have considerable clinical benefits in terms of reducing non-compliance with medications, and reduction of illness burden and distress. Design: Potential participants will be sent study information with their appointment letter. On the day of their appointment they will be provided with verbal + written information on the project, and invited to participate by the research assistant. Once written informed consent has been obtained, a baseline questionnaire (including symptom data) will be completed. Participants will be randomised into one of 2 groups; either a) control: standardized preparation for IV iron infusion including side effect information, or b) intervention: standardized preparation for IV iron including side effect information plus explanation of nocebo effect. The control and intervention conditions will be delivered by a consultant anaesthetist (according to a standardised script for each condition). The nocebo intervention will outline the relationship between bodily sensations and individuals‘ attributions, expectations, and beliefs, and will offer an explanation of the nocebo phenomenon. The research assistant (who will be blind to condition) will collect participant symptom data following IV iron infusion and at day 3 post-infusion.

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