The Effect of Video-Based Educational Content for Parents and Children on Anxiety, Fear, and Pain During Blood Draw in Children: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Pain Means
研究概览
简要总结
This study aimed to examine the effect of video-based educational content prepared for parents and children on anxiety, fear, and pain levels experienced by children aged 4-7 during venipuncture procedures.
详细描述
This study aim to examine the effect of video-based educational content prepared for parents and children on anxiety, fear, and pain levels experienced by children aged 4-7 during venipuncture procedures.The study a single-centre, randomized controlled trial. The study will conduct in the pediatric phlebotomy unit of a university hospital's central laboratory in Turkey.
This randomized controlled trial will included 80 children aged 4-7, randomly assigned to intervention and control groups. The control group will receive routine clinical care before, during, and after venipuncture. In the intervention group, children and their parents will shown video-based educational content prior to the procedure. Data collection tools included a Child and Family Information Form, the Children's pain, Fear, and the Child Anxiety Scale. The normality of fear, anxiety, and pain scale scores will evaluate with the Shapiro-Wilk test. Repeated measures analysis of variance (ANOVA) will applied to compare scale scores across groups and time points. Within-group comparisons will conduct using one-way repeated measures ANOVA, while between-group differences at each time point were assessed with independent samples t-tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants in the study will assign using a stratified randomization method. Strata will create based on gender (two groups: female and male) and age (four groups: 4, 5, 6, and 7 years), and random sampling will perform within each stratum. The matching of the child with the nurse performing the blood draw will do randomly using the institution's routine queue management system. A nurse not involved in the study will assign each child to group and nurse who performing the blood draw based on their arrival number in the institution's blood draw queue system according to the previously determined randomization scheme. After the study is completed, the group names will be blinded, allowing analyses to be conducted without revealing the group names to the statistician.
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children who will between the ages of 4-7,
- •Children who will Blood collection procedure
- •Have no cognitive development problems,
排除标准
- •Children who will not want to participate in the study,
- •Leave the research during the study,
- •Have an audio-visual disorder that could prevent the use of video
研究组 & 干预措施
Experimantel
Parents of children in the intervention group will inform that the educational videos used in the study aim to reduce the child's pain, fear, and anxiety. An informational video willprepare by the researchers will show to the parents, while an age-appropriate video explaining the blood collection process will shown to the children.
The video content wil structured in accordance with the existing literature Characters featured in the parent and child videos will select, and separate scenarios for each group will developed by the researchers. Video recordings will conduct outside of working hours in the blood collection unit, accompanied by a professional cameraman. To evaluate the feasibility and comprehensibility of the videos, a pilot study will conduct with five children and their parents who will not included in the main study.
The parent video addressed the attitudes and behaviors that parents should exhibit before, during, and after the blood collection procedure.
干预措施: Video-Based Education (Behavioral)
No Intervention: Control Group
No intervention
结局指标
主要结局
Pain Means
时间窗: Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt
Pain score will be measured with the Children's Pain Scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's pain increases. In this study, if children get high scores from the pianscale, it will be determined that they have high procedural pain. Getting a low score from the scale will indicate that their pain about the procedure is low.
Anxiety Means
时间窗: Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt
Anxiety score will be measured with the Child Fear and Anxiety Scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's anxiety increases. In this study, if children get high scores from the anxiety section of the scale, it will be determined that they have high procedural anxiety. Getting a low score from the scale will indicate that their anxiety about the procedure is low.
Fear Means
时间窗: Five minutes before the blood draw attempt, during the blood draw attempt, and five minutes after the blood draw attempt
Fear score will be measured with the Children's fear and anxiety scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's fear increases. In this study, if children score high on the fear section of the scale, it will be determined that their fear of the procedure is high. A low score on the scale will indicate that fears about the procedure are low.
次要结局
未报告次要终点
研究者
Murat Bektaş
Head of Department
Dokuz Eylul University