Pasqualucci Paula, Seifert Georg, Filho Vicente Odone, Dos Santos Angelica Carreira
Unit of Integrative Pediatrics, Faculty of Medicine, University of Sao Paulo, Sao Paulo, Brazil.
Department of Pediatrics, Division of Oncology and Hematology, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Pilot Feasibility Stud. 2022 Sep 30;8(1):220. doi: 10.1186/s40814-022-01176-z.
The prevalence of chronic and complex pediatric health conditions has quickly risen over the last decades. Chronic and complex health conditions make pediatric patients and their families more susceptible to many distressing events during their lifespan. Mindfulness-based interventions have become a popular intervention for individuals living with chronic illnesses and have been adapted for pediatric populations with good results, including online versions. This study intends to report an implementation protocol of an online mindfulness-based program for adolescents to address an important gap in stress relief and health promotion for pediatric patients.
In this article, we describe the rationale and design of an implementation study of an online mindfulness-based program for pediatric patients at a tertiary pediatric hospital in South America. Participants will be recruited during one year to participate in an eight-session online mindfulness-based program. To assess our primary aim of feasibility, we will exam recruitment, retention and participation rates. Participants will also complete a symptomatology evaluation (i.e., depression, anxiety, and stress symptoms) at baseline and immediately at post-treatment and fidelity will be evaluated by a structured questionnaire.
This study will be the first known to assess the implementation of an online mindfulness-based program for a pediatric population at a tertiary pediatric center in South America under real-life conditions. This study will establish the feasibility of a novel intervention aimed at promoting mental health and positive coping strategies among pediatric patients with chronic and complex health conditions. Evidence from this study would be useful to patients, families, clinicians, and policymakers and will help to devise strategies of health promotion for the pediatric population, as well as serve as a model for a future trial to examine efficacy of the proposed intervention.
This research has been registered at Ensaiosclinicos.gov.br , identifier RBR-23trp87 . Registered 25 February 2022-retrospectively registered.
在过去几十年中，慢性和复杂儿科健康状况的患病率迅速上升。慢性和复杂的健康状况使儿科患者及其家庭在其一生中更容易遭遇许多令人痛苦的事件。基于正念的干预措施已成为慢性病患者常用的干预方法，并已应用于儿科人群且取得了良好效果，包括在线版本。本研究旨在报告一项针对青少年的在线正念项目的实施方案，以填补儿科患者压力缓解和健康促进方面的重要空白。
在本文中，我们描述了在南美洲一家三级儿科医院针对儿科患者开展的在线正念项目实施研究的基本原理和设计。将在一年内招募参与者参加一个为期八节的在线正念项目。为了评估我们可行性这一主要目标，我们将考察招募、留存和参与率。参与者还将在基线时、治疗后立即完成症状学评估（即抑郁、焦虑和压力症状），并通过结构化问卷评估保真度。
本研究将是已知的首个在现实生活条件下评估南美洲一家三级儿科中心针对儿科人群实施在线正念项目的研究。本研究将确定一种旨在促进患有慢性和复杂健康状况的儿科患者心理健康和积极应对策略的新型干预措施的可行性。本研究的证据将对患者、家庭、临床医生和政策制定者有用，并将有助于制定针对儿科人群的健康促进策略，也可作为未来试验检验所提议干预措施疗效的模型。
本研究已在Ensaiosclinicos.gov.br注册，标识符为RBR - 23trp87。于2022年2月25日注册——追溯注册。
