Evaluation of an Intervention by a Pedagogical Digital Game About Radiotherapy for Children With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Children's State anxiety, change is being assessed
研究概览
简要总结
Background: Radiotherapy (RT) can be stressful and challenging for children exposed to a highly technical environment with large radiation equipment and immobilization devices. A pedagogical digital game about RT has been developed. Children who have received RT participated in work-shops and contributed with their experiences and suggestions.
Aim: To explore whether the intervention with a pedagogical digital game facilitate understanding, choice of distraction, creation of a sense of calmness and self-efficacy prior to and during RT and to describe the children's and the parents experiences and use of the game as a pedagogical tool. Further, to investigate feasibility in terms of reach, usability and acceptability.
Method: A feasibility and prospective waiting list control design is planned by recruiting 60 children (5-14 years) and their parents, for randomization into two groups. The first group will receive the game five days before start of RT. All children will have standard information one day before RT. The second group will have access to the game three days after start of treatment. The effects of the game will be investigated before and during RT and between groups as they receive the game at different time. Children will answer questionnaires about self-assessed anxiety, understanding of the procedure, distraction strategies, self-efficacy to remain motionless. Statistical comparative and correlational analyses will be calculated. Interviews will be performed with 12 children and 24 parents. Changes and further development of the game will be implemented based on the results of the responses.
Significance: The game can support children to undergo RT and be used nationally to prepare for RT. Thus all children receive similar information regardless of where they live, and contribute to increased knowledge, autonomy, reduce fear and anxiety. In the long term, the use of anesthesia could decrease for children.
详细描述
Data Collection and procedure:
Access to the game for children randomized to the first group: Four to six days before start of treatment.
Questionnaires to all children: Questions about state and trait anxiety, and radiotherapy before the information meeting with the oncology nurse, one day before the start of treatment, at baseline.
Questionnaire to parents: Questions about state and trait anxiety before the information meeting with the oncology nurse at baseline.
Information meeting with all children and their parents: Information about radiotherapy by oncology nurse at baseline Questionnaires to all children: Questions about state anxiety and radiotherapy on treatment day one and three.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Non-blinded
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-14 years old who are going to have radiotherapy at the Skandion Clinic, Uppsala with or without sedation/anesthesia, understand and can speak Swedish and have access to a computer.
排除标准
- •Severe cognitive impairment and too seriously ill to be able to answer questions.
研究组 & 干预措施
Game before RT start
Intervention of a digital game five days before start of RadioTherapy
干预措施: Game about radiotherapy (Procedure)
Game after RT start
Intervention of a digital game three days after start of RadioTherapy
干预措施: Game about radiotherapy (Procedure)
结局指标
主要结局
Children's State anxiety, change is being assessed
时间窗: Baseline and on treatment day three, six and 15
From the questionnaire STAI-C1
次要结局
- Children's self-efficacy to remain motionless, change is being assessed(Baseline and on treatment day three)
- Children's perception of the digital game about radiotherapy: usability and engagement(One week after the intervention)
- Children's Trait anxiety(Baseline)
研究者
Gunn Engvall
Ass. Professor
Uppsala University