Effectiveness of Mobile Application Intervention on Preschool Children's Fear and Pain and Their Parents' Anxiety and Stress in Day Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Parents' Anxiety measured with STAI-Y1.
研究概览
简要总结
In Finland about 50% of surgical operations for all under 16 years of age are made as day surgery which means that the patient comes to the hospital and is discharged on the day of the operation. Day surgery will continue to grow in the next few years. Its benefits include shorter hospitalization, family reunion and rapid recovery. The preschool children and their parents who come in for day surgery feel fear, anxiety and stress, which depend on the amount of knowledge and its quality. By developing the preparation of preschool children and their parents for day surgery, and by testing new methods more attention can be paid to the special features of day surgery, supporting the families, and increasing family involvement in the whole process.
The purpose of this study is to describe and evaluate the effectiveness of a new mobile application intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. The aim is to produce new information and to develop day surgery of preschool children.
The study consist of two phases. The first phase of the research is a systematic literature review and meta-analysis. The purpose of the review is to assess and describe the methods previously used in the preparation of parental day surgery and their effectiveness for preschool children fear and pain and parents' anxiety and stress. The second phase of the study is carried out as a randomized controlled trial (=RCT). The parents of the preschool children are randomized to the mobile application group (n = 50-60) and the control group (n = 50-60). The sample size is based on power-analysis, with anxiety as the primary outcome. The material for the second phase of the study is collected at the day surgery department of the Oulu University Hospital. The study group is prepared for day surgery with a new mobile application and the control group according to the traditional preparing method. The study examines the effectiveness of a new intervention compared to the effectiveness of the traditional preparing method when measuring preschool children's fear and pain and their parents' anxiety and stress. The collected data are analyzed using the Mann-Whitney, t-test, Khi square test, and Fisher's accurate test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1 or 2
- •ELECTIVE DAY SURGIGAL PROCEDURE IN 3-4 WEEKS
- •PARENT ABLE TO USE MOBILE INTERVENTION, UNDERSTANDS FINNISH AND WILLING TO PARTICIPATE IN PREPARING CHILD FOR DAY SURGERY
- •GENERAL ANAESTHESIA
排除标准
- •INCLUSION CRITERIA NOT MET
研究组 & 干预措施
mobile intervention
families to be prepared for day surgery with a mobile application
干预措施: Mobile application (Other)
control group
families to be prepared for day surgery with current practice
干预措施: current practice (Other)
结局指标
主要结局
Parents' Anxiety measured with STAI-Y1.
时间窗: fourth measurement at home within 1-7 days after the procedure
The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most commonly used version of the STAI meter and only it's STATE-A section is utilized. Here, the parent evaluates his own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.
Parents' Anxiety measured with STAI-Y1.
时间窗: first measurement at home before the procedure
The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most commonly used version of the STAI meter and only it's STATE-A section is utilized. Here, the parent evaluates his own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.
Parents' Anxiety measured with STAI-Y1.
时间窗: second measurement in the hospital before the procedure
The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most commonly used version of the STAI meter and only it's STATE-A section is utilized. Here, the parent evaluates his own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.
Parents' Anxiety measured with STAI-Y1.
时间窗: third measurement in the hospital before discharge
The STAI meter is a two-part adult anxiety meter developed by Charles D. Spielberg and his research team (1983). It separates situation related anxiety (STATE-A = Y1) from character related tendency towards anxiety (TRAIT-A). In this study, the most commonly used version of the STAI meter and only it's STATE-A section is utilized. Here, the parent evaluates his own current anxiety on a four-step scale with twenty questions. The respondents choose from the following options at each question: 1 = no anxiety at all, 2 = slight anxiety, 3 = some anxiety 4 = very much anxiety.
次要结局
- Children's Pain with PPPM(fourth measurement at home within 1-7 days after the procedure)
- Parents' Stress with VRSS(fourth measurement at home within 1-7 days after the procedure)
- Children's Fear with FAS(fourth measurement at home within 1-7 days after the procedure)
- Children's Pain with VAS(fourth measurement at home within 1-7 days after the procedure)
- Children's Fear with FAS(first measurement at home before the procedure)
- Parents' Stress with VRSS(first measurement at home before the procedure)
- Parents' Stress with VRSS(second measurement in the hospital before the procedure)
- Parents' Stress with VRSS(third measurement in the hospital before discharge)
- Children's Fear with FAS(second measurement in the hospital before the procedure)
- Children's Fear with FAS(third measurement in the hospital before discharge)
- Children's Pain with PPPM(first measurement at home before the procedure)
- Children's Pain with PPPM(second measurement in the hospital before the procedure)
- Children's Pain with PPPM(third measurement in the hospital before discharge)
- Children's Pain with VAS(first measurement at home before the procedure)
- Children's Pain with VAS(second measurement in the hospital before the procedure)
- Children's Pain with VAS(third measurement in the hospital before discharge)