Nursing Graduate Program, Federal University of Rio Grande do Norte, Natal, Brazil.
Health Sciences Postgraduate Program, Federal University of Rio Grande do Norte (UFRN), Natal, RN, Brazil.
PLoS One. 2023 May 9;18(5):e0285250. doi: 10.1371/journal.pone.0285250. eCollection 2023.
Childhood cancer affects approximately 600,000 children and adolescents worldwide, and chemotherapy is the main form of treatment. However, chemotherapy treatment causes feelings of fear and anxiety especially in the patient's caregiver. Thus, strategies that help the health education process directed towards caregivers are essential for strengthening knowledge and reducing anxiety involved with the beginning of treatment.
To present a study protocol to evaluate the effect of a multimedia strategy compared to standard guidelines for acquiring knowledge and reducing anxiety among caregivers of children and adolescents with cancer undergoing chemotherapy.
A randomized, controlled, single-blind, two-armed clinical trial will be carried out. Fifty-two caregivers of children and adolescents who will start chemotherapy will participate in the study, which will be randomly assigned into Experimental Group, which involves the evaluation of the effect of a multimedia strategy composed of a digital animation film about the chemotherapy process, used as tool for health education or into Control Group, which assesses the effects of standard guidelines, which are verbally provided. Two important moments will be considered to evaluate the results of the intervention (P1, and F1). The primary outcome includes reduced anxiety and the secondary outcome refers to the caregivers' acquisition of knowledge about chemotherapy treatment.
The results of this randomized clinical trial will have a positive impact on the participants' knowledge acquisition, and will also contribute to reduce anxiety observed at the beginning of treatment related to the caregivers' knowledge deficit. The level of knowledge between groups with anxiety before and after intervention will be compared, highlighting which intervention had the best effect.
Registration: RBR-4wdm8q9-Brazilian Registry of Clinical Trials-REBEC (23/03/2022). This study was approved by the Research Ethics Committee of the Federal University of Rio Grande do Norte- UFRN, under CAAE-52597121.9.0000.5537.
儿童癌症影响全球约 60 万名儿童和青少年,化疗是主要的治疗形式。然而,化疗治疗会引起患者及其照顾者的恐惧和焦虑感。因此,帮助面向照顾者的健康教育过程的策略对于加强知识和减轻治疗开始时的焦虑感至关重要。
介绍一项研究方案,以评估多媒体策略与标准指南相比,对接受化疗的儿童和青少年癌症照顾者获取知识和减轻焦虑的效果。
将进行一项随机、对照、单盲、双臂临床试验。52 名将要开始化疗的儿童和青少年的照顾者将参与研究,他们将被随机分配到实验组,实验组评估由关于化疗过程的数字动画电影组成的多媒体策略的效果,作为健康教育工具;或分配到对照组,评估标准指南的效果,标准指南以口头形式提供。将考虑两个重要时刻来评估干预的结果(P1 和 F1)。主要结果包括焦虑减轻,次要结果是指照顾者对化疗治疗的知识获取。
这项随机临床试验的结果将对参与者的知识获取产生积极影响,并有助于减轻与照顾者知识不足相关的治疗开始时的焦虑。将比较干预前后有焦虑的组之间的知识水平,突出哪种干预效果最好。
注册:RBR-4wdm8q9-巴西临床试验注册中心-REBEC(2022 年 3 月 23 日)。本研究得到了北里奥格兰德州联邦大学 UFRN 研究伦理委员会的批准,注册号为 CAAE-52597121.9.0000.5537。