Measures to Address Maternal Anxiety

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2011
INTERVENTION: Adrenaline auto‐injector: participants will be randomised to receive training with either Anapen® or EpiPen®. Informational intervention: participants will be randomised to receive either a new approach to discussing food allergy or current standard of care. Study Entry: Single Randomisation only CONDITION: Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases ; Not Applicable ; Children with food allergy PRIMARY OUTCOME: State anxiety (STAI) score; Timepoint(s): 6 weeks (primary outcome) and 12 months (secondary outcome) SECONDARY OUTCOME: Successful administration of adrenaline using a trainer device, judged by an independent observer; Timepoint(s): 6 weeks (primary) and 12 months (secondary) INCLUSION CRITERIA: Pilot phase: Parents of children attending the paediatric outpatient department at St Mary's Hospital ? food allergic/atopic/healthy groups categorised according to diagnoses made by the treating clinician. Food allergic group will be limited to those with IgE‐mediated food allergy. Main study: 1. Children aged 0‐18 with food allergy (and their mother) diagnosed at a tertiary paediatric allergy clinic and need for adrenaline auto‐injector prescription due to risk of anaphylaxis 2. Patient weight = 7.5 kg 3. Ability to converse fluently and read instructions in English or with an appropriate translator
Epistemonikos ID: 0b98ea603833a2869478c84ba273324f612514b5
First added on: Aug 22, 2024