Warm compresses and cold packs for prevention of perineal pain after vaginal birth : PERISAFE RCT Data kit

Data Kit Description Study title: Thermotherapy for prevention of perineal pain after vaginal birth: evaluation of warm compresses and cold packs using a factorial randomized controlled trial Contents of the Data Kit: Dataset – the main dataset from the trial Data dictionary – detailed description of all variables, including types, units, categories, and anonymization notes Analysis script – code to reproduce the analyses of the trial and ensure transparency, traceability, and reproducibility Anonymization and data handling: The dataset has been deidentified to protect participant confidentiality. Some variables have been categorized or removed to reduce re-identification risk. Data access : this dataset is intended for restricted access upon request to the contact person. Protocol registration: The PERISAFE protocol was registered in the ClinicalTrial database (2021-03-03, No. NCT04778631) Funding: The Perisafe study was funded by the APICIL Foundation and the PRIDE award from the FHU (University Hospital Foundation) Prema.数据集套件说明 研究标题：阴道分娩后会阴部疼痛预防的热疗：采用析因随机对照试验评估温热敷与冷敷 数据集套件内容： 1. 数据集——本试验的核心主数据集 2. 数据字典——对所有变量的详细说明，涵盖变量类型、计量单位、分类方式及匿名化备注 3. 分析脚本——用于复现本试验全部分析流程的代码，以保障研究的透明度、可追溯性与可重复性 匿名化与数据处理： - 本数据集已完成去标识化处理，以保护受试者的隐私与机密性 - 部分变量已进行分类或移除，以降低反向身份识别的风险 数据获取方式：本数据集仅可通过向指定联系人提出申请后，以受限权限获取 试验方案注册：本PERISAFE研究方案已在ClinicalTrial数据库完成注册（2021年3月3日，登记号：NCT04778631） 资助情况：本Perisafe研究由APICIL基金会以及FHU（大学医院基金会）Prema项目的PRIDE奖项资助