To assess the impact of digital picture books on preoperative anxiety, pain and sleep quality in young children undergoing cardiac catheterisation and the anxiety of their family caregivers. A randomised, single-blinded, two-arm, parallel-group controlled trial. Participants are young children aged 2-7 years with congenital heart disease scheduled for cardiac catheterisation and their family caregivers. They were enrolled at Fujian Medical University Union Hospital between September 2022 and July 2023. They were randomised to either a control group receiving usual care or an intervention group receiving digital picture book sessions. Anxiety and pain levels were assessed using standardised scales, and sleep quality was measured using actigraphy. The study included 64 pairs of young children and family caregivers. Digital picture books significantly reduced preoperative anxiety and bandage removal pain in children and anxiety in family caregivers. However, there was no statistical difference in sleep quality between the intervention group and the control group. Digital picture books prove to be an effective intervention for reducing anxiety and pain in paediatric cardiac catheterisation patients and anxiety of their family caregivers. The intervention did not affect sleep quality, suggesting the need for additional strategies to address this aspect of the hospital experience. This study demonstrated the effectiveness of digitally illustrated books in reducing preoperative anxiety and pain in young children and anxiety in family caregivers. Digital picture books offer a creative and engaging way to help children and their families cope with the stress and anxiety associated with medical procedures. Further research in this area may lead to the development of more innovative and effective interventions for paediatric patients and their family caregivers. The study's impact lies in its innovative approach to addressing the psychological and emotional challenges faced by young children and their family caregivers during the stressful experience of cardiac catheterisation. By demonstrating the efficacy of digital picture books in significantly reducing preoperative anxiety and postoperative pain, the research presents a non-pharmacological, accessible and engaging intervention that can be seamlessly integrated into existing healthcare practices. The findings have the potential to transform paediatric care by offering a safe, developmentally appropriate and cost-effective method to support the emotional well-being of children and their families, thereby enhancing the overall patient experience and clinical outcomes. Moreover, the study's emphasis on family caregiver involvement underscores the importance of a holistic approach to care that considers the needs of both the patient and their support system. Children and their family caregivers were invited to provide valuable input which has been critical to the development of the intervention. The participant information sheet and consent form, as well as the consent/recruitment process, were reviewed by a consumer advisor advocate from the pilot study. CONSORT. Chinese clinical trial registry: ChiCTR2200063973. Registered on 22 September 2022, https://www.chictr.org.cn/showproj.html?proj=132833.
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