The EFFECT of STRESS BALL on REDUCING the FEAR and PAIN OCCURRENT DURING the PROCEDURE in CHILDREN
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 3
- 主要终点
- Pain scores
研究概览
简要总结
This research was planned in a Randomized Controlled Experimental Research design with Pre-Test-Post-Test Control Group in order to determine the effect of the stress ball squeezing technique applied to children aged 7-12 during the vascular access procedure on the level of fear and pain in children. The data of the study were obtained from children aged 7-12 who came to the Karaman Training and Research Hospital Pediatrics Service between August 1 and October 31, 2020. The sample size was determined as 116 children in total, 58 children for each group. "Interview and Observation Form, Children's Fear Scale (CFS), Wong-Baker Faces, Stress Ball and Stopwatch" were used for data collection.
In order to evaluate whether the research is ethically appropriate, an application was made to the Ethics Committee of Karamanoğlu Mehmetbey University School of Health Sciences and the necessary permission was obtained. Written permission was obtained from the Chief Physician of Karaman Training and Research Hospital in order to conduct the study in the Child Health and Diseases Service of Karaman Training and Research Hospital.
Statistical analyzes of the study will be done in SPSS 21.0 package program. Number, percentage, mean and standard deviation values will be used from descriptive analyses. In the analysis of differences between groups, independent groups t test, paired t test, Anova, Mann Whitney U and Kruskal Wallis tests will be used. Tukey or Duncon tests will be used for further analysis. The change in the post-procedural pain level of children according to some variables will be evaluated with multiple and simple regression analyses. Significance level will be accepted as p<0.05.
详细描述
Dependent variable: Children's level of pain and fear Independent variable: Stress ball, demographics, previous painful transaction experience Randomization of control and stress ball groups; The status of the children to be included in the study in the control or stress ball group was determined by using "stratification and randomization methods with blocks". In the literature, it has been reported that gender and fear of interventional procedures are among the factors affecting the fear and anxiety experienced by children in interventional procedures (Törüner & Büyükgönenç, 2012; Çavuşoğlu, 2013). Accordingly, stratified and block randomization will be applied to the children as "girl and boy" for the gender variable and "afraid and not afraid" for the fear of the procedure. 58 children will be included in each of the research groups. During the data collection process, each child and family will be taken to the invasive procedure room individually. This will prevent children from meeting with each other.
The determined layers were created by the statistician as codes obtained from a permutation-based computer program (https://www.randomizer.org). At the beginning of the study, which letter would be the stress ball or the control group was determined by the closed opaque envelope method, and the letter A was used for the stress ball group and the letter B was used for the control group.
Blinding: Single blinding (participants) will be used in the study. Participants will not be told whether they are in a stress ball or control group. A separate informed consent form will be created and approved for each group. In order to prevent children and parents from encountering each other, information will be given in the closed operation room and their consent will be obtained. Each child will be taken to a separate room with one of their parents. It will be ensured that no child is waiting near the door for invasive intervention.
Hypotheses H0: The stress ball applied during the vascular access procedure does not affect the fear and pain levels of children.
H1: The stress ball applied during the venipuncture procedure affects the children's fear levels H2: The stress ball applied during the vascular access procedure affects the pain levels of children.
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
- Single (Participant)
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The child is between the ages of 7-12
- •Absence of pain (due to disease, drug side effects, distension)
- •Absence of any physical or mental illness
- •Being able to communicate and being open to communication
- •No history of ischemic epilepsy, migraine or vestibular disorder
- •No long-term illness.
- •Absence of a regularly used medication
- •Not taking analgesics in the last six hours
- •Hospitalization for diagnosis or treatment
- •Vascular access is performed by the same nurse,
- •Single way vascular access
- •The child and parent speak and understand Turkish comfortably,
- •The child and his parents do not accept to participate in the study, and they do not have a speech or vision disorder.
排除标准
- •who do not meet the inclusion criteria.
结局指标
主要结局
Pain scores
时间窗: 5 minutes
Fear scores
时间窗: 5 minutes
次要结局
未报告次要终点
研究者
Ayse Sonay Turkmen, Prof.Dr
Assoc.Prof.
Karamanoğlu Mehmetbey University