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

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2016
INTERVENTION: Brief name: Comparison of effect of standard information vs. standard information plus nocebo explanation on side effect reporting after intravenous iron infusion. Participants (patients receiving IV iron infusion at Auckland City Hospital) who are randomised into the intervention group will receive a standard consultation for IV iron infusion (including side effect information) plus an explanation of nocebo effect. The nocebo explanation will outline the relationship between bodily sensations and individuals‘ attributions, expectations, and beliefs, and will offer an explanation of the nocebo phenomenon. The intervention consultation will be delivered by a Consultant Anaesthetist according to a standardised script. The mode of delivery will be face to face and executed individually to each patient. The intervention will be delivered once per patient over approximately a 10 minute period The intervention will be delivered at the Post Anaesthetic Care Unit on Level 8 of Auckland City Hospital (Auckland, New Zealand). After the intervention has been delivered participants will be asked to complete a post infusion symptom questionnaire. Participants will also be contacted via telephone 3 days after their infusion to complete the same symptom questionnaire. CONDITION: Intravenous iron infusion ‐Indicated for patients with iron deficiency anaemia for whom oral iron is considered considered unsuitable or has been unsuccessful e.g. due to malabsorption, continuing blood loss, poor adherence or intolerance to oral iron, preoperative iron deficiency anaemia PRIMARY OUTCOME: Side effect reporting ; ; Side effects will be assessed by self‐report on a (study‐designed) questionnaire. The participant will complete this questionnaire. SECONDARY OUTCOME: side effect reporting INCLUSION CRITERIA: To be eligible to participate in the trial, individuals must: ‐be over 18 years of age ‐be a patient referred to the Auckland City Hospital Anaesthesia Department for an IV iron infusion
Epistemonikos ID: 8e9a85108fe7490442f632a34c978a2b328c8bca
First added on: Aug 25, 2024