Multicentre randomised controlled trial evaluating PARO for pain and anxiety during peripheral intravenous cannulation in children in French paediatric emergency departments and paediatric units: study protocol.

چکیده اصلی

INTRODUCTION: Peripheral intravenous cannulation (PIVC) is one of the most frequently performed procedures in paediatric emergency and hospital settings and is often associated with significant pain and anxiety in children. Non-pharmacological interventions may complement standard pain management strategies. This trial will evaluate the effectiveness of PARO, an interactive therapeutic robot, in reducing pain and anxiety during PIVC in children. The study aims to provide clinically relevant evidence to support the integration of socially assistive robots into paediatric pain management. METHODS AND ANALYSIS: This will be an open-label, multicentre, randomised controlled superiority trial conducted in five paediatric centres in France. A total of 120 children aged 12 months to 7 years requiring PIVC will be randomly assigned (1:1) to receive either standard pain management alone or standard pain management plus the PARO robot during the procedure. Randomisation will be stratified by age and centre using a centralised electronic system. Due to the nature of the intervention, blinding of participants and outcome assessors will not be feasible.The primary outcome will be the change in pain intensity assessed using the Face, Legs, Activity, Cry, Consolability scale between baseline (15 min before the procedure) and the time of cannulation. Secondary outcomes will include children's distress assessed using the Procedural Restraint Intensity in Children scale, changes in heart rate, number of attempts required for successful cannulation, parental anxiety assessed using the State Trait Anxiety Inventory questionnaire, parental satisfaction and healthcare professional satisfaction. Statistical analysis will be performed on an intention-to-treat basis using analysis of covariance adjusted for stratification factors, with results reported as effect estimates with 95% CIs. ETHICS AND DISSEMINATION: The study has received approval from the French National Agency for Medicines and Health Products Safety and the French Committee for the Protection of Personal Data (CPP Ouest I Tours) on 3 July 2025 (No. 25.02471.000436) and is registered at ClinicalTrials.gov (NCT07299006). Results will be disseminated through publication in peer-reviewed journals, presentation at national and international conferences, and communication to healthcare professionals, stakeholders and participants. TRIAL REGISTRATION NUMBER: NCT07299006.

ترجمه فارسی چکیده

سوزن‌زنی وریدی محیطی (PIVC) یکی از فرآیندهای متداول در بخش‌های اورژانس و بیمارستان‌های اطفال است که اغلب با درد و اضطراب قابل توجهی همراه است. این مطالعه اثربخشی پارو، یک ربات درمانی تعاملی، در کاهش درد و اضطراب حین PIVC را در کودکان ارزیابی می‌کند. این یک آزمایش بالینی تصادفی کنترل‌شده برتری (RCT) چندمرکزی بازلین در پنج مرکز اطفال فرانسه است. ۱۲۰ کودک در سن ۱۲ ماه تا ۷ سال نیازمند PIVC به صورت تصادفی (۱:۱) به دو گروه تقسیم می‌شوند: مدیریت استاندارد درد به تنهایی یا مدیریت استاندارد درد به همراه ربات پارو. شاخص اصلی تغییر شدت درد بر اساس مقیاس Flicker (FLACC) بین پایه (۱۵ دقیقه قبل از فرآیند) و زمان سوزن‌زنی است. شاخص‌های ثانویه شامل اضطراب کودک، تغییر ضربان قلب، تعداد تلاش‌های مورد نیاز برای موفقیت، اضطراب والدین و رضایت والدین و کارکنان سلامت است. تحلیل آماری بر اساس اصل درمان تمام شرکت‌کنندگان (ITT) انجام می‌شود.

متن کامل اصلی