The Effect of Supporting the Incision Site With Toys During Mobilization on Pain and Fear Levels in Children Aged 4-10 Years Undergoing Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Children Information Form
研究概览
简要总结
Aim: The aim of this study is to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery. Method: The study was a randomised controlled trial. The study sample consisted of 74 children (Toy: 37, control: 37) who has undergone abdominal surgery between March 2026 and December 2026 at the Mersin University Hospital Pediatric surgery department. The data collection tools used will be the Children Information Form, Wong Baker Pain Scale , Fear scale. In the intervention group, toy will be used after surgery, while the control group will receive routine care. The chils' pain and fear levels will be assessed by the nurse before and after the procedure.
详细描述
The study will be conducted as a randomized controlled trial to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery.
Materials and Methods Setting The research will be conducted at the Pediatric Surgery Department of Mersin University Hospital between March and December 2026. The Pediatric Surgery Department is where elective day surgeries and emergency surgical interventions are performed, and where pre- and post-operative care is provided.
Sample When determining the sample size for the study, the scientific study titled "The Effect of Mobilization with Environmental Play on Fear and Pain Levels in the Postoperative Period of Children Aged 6-12 Years Who Underwent Acute Appendectomy" by Akdağ (2019), based on literature reviews to determine the sample size for effect size, was used as a basis. According to the study, the Power analysis (G*Power 3.1.9.2) resulted in an effect size of 0.896, a 95% confidence interval, and a 95% power, requiring a total of 68 children, with at least 34 in each group. Considering the possibility of dropouts and confounding variables during the research process, a total of 74 children were determined, with 37 children in each group.
Data Collection The necessary ethics committee and institutional approvals will be obtained before starting the research.
- Phase: Data collection forms to be used prior to the research will be pilot tested with 10 children to assess the suitability of the plush toy selected for support.
- Phase: The children and family members in the sample group will be informed about how the application will be carried out and about the research, and written consent will be obtained from the family and verbal consent from the child.
- Phase: Children meeting the sample selection criteria will be randomly and equally distributed into two groups (1st study group and 2nd control group) using a computer program to ensure randomization. "(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html)".
- Phase: The pain and fear levels of children in all groups prior to mobilization will be assessed by the child, parent, and nurse. The child's vital signs will be recorded by the nurse prior to mobilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 4 and 10 years
- •Having undergone abdominal surgery
- •Having undergone surgery under general anesthesia
- •Having received a single dose of analgesic (paracetamol) after surgery
- •Having undergone initial mobilization after surgery
- •Volunteering to participate in the study
排除标准
- •Previous surgical intervention
- •Major surgery
- •Chronic illness
- •The child has visual, hearing, and mental disabilities
研究组 & 干预措施
Toy Group
The incision sites of children in this group will be supported with a plush toy immediately before the procedure begins and will continue to be supported throughout mobilization. When the patient is transferred to the hospital bed, the support with the plush toy will be discontinued.
干预措施: Toy Group (Other)
Control Group
Children in this group will receive parental support as part of the clinic's routine.
结局指标
主要结局
Children Information Form
时间窗: 1 day
The form, prepared in line with the literature, consists of 24 questions regarding the sociodemographic characteristics of children. A 3-point Likert-type observation form created by the researcher will be used in this form to evaluate children's participation in the mobilization process. Scoring is categorized as follows: '3: Willing/Active Participation', '2: Reluctant/Variable Participation', and '1: Unwilling/Resistant'. The researcher observed the child's verbal and behavioral responses during mobilization preparation and the walk and assigned the relevant score.
Wong-Baker Pain Scale
时间窗: 1 day
Developed in 1981 by Donna Wong and Connie Morain Baker to assess children's pain levels, it was revised in 1983. There are six facial expressions scored from zero to ten. The Wong-Baker Scale features faces that show increasing pain intensity from zero to six, moving from left to right.
Fear Scale
时间窗: 1 day
Thurillet et al. (2022) developed this scale to assess children's fears based on self-reports from children aged 4-12. The Turkish validity and reliability study was conducted by Tavşan et al. (2024). The scale consists of six facial expressions. The scale rates fear on a scale ranging from 0 to 10 (rated incrementally in twos), consistent with pain rating scales. The first facial expression indicates no fear, while fear increases as one moves from right to left, with the sixth facial expression indicating the highest level of fear. A statistically significant, very high positive correlation was found between the Fear Scale and the Children's Fear Scale (r=0.973; p\<0.001). The high correlation value between the two forms indicates that the children's form is valid. The scale's content validity index and item content validity index values were found to be 0.98. A very good level of statistically significant agreement was found between the Fear Scale and the Children's Fear Scale (Kappa
次要结局
未报告次要终点
研究者
Duygu Sonmez Duzkaya
Principal Investigator
Tarsus University