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临床试验/NCT07404163
NCT07404163进行中(未招募)不适用

The Effect of a Walkway Used in Postoperative Mobilization on Children's Pain, Fear, and Time to Initiate Mobilization

Tarsus University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2026年2月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
74
试验地点
1
主要终点
Wong Baker Pain Scale

研究概览

简要总结

Introduction Surgical operations are increasing globally, with abdominal surgeries accounting for approximately 70% of these procedures. Despite the prevalence, postoperative complications occur in 30-60% of cases, leading to prolonged hospital stays, increased mortality, and higher healthcare costs. Early mobilization is a critical component of Enhanced Recovery After Surgery (ERAS) protocols, known to reduce surgical stress, muscle atrophy, and pulmonary complications. However, implementation in pediatric care is often limited, as children may perceive mobilization as a "task" rather than a part of healing.

Purpose The primary aim of this study is to investigate the effects of a low-cost, distraction-based Walkway (Mat Carpet) on pain levels, fear, and the time to initiate mobilization in children aged 4-10 who have undergone abdominal surgery.

详细描述

Early mobilization is defined as the patient's ability to stand up and walk as soon as possible after surgery or after illness, depending on the type of operation performed and the course of the disease. Early mobilization is considered and recommended as one of the factors that accelerate recovery. One study indicated that initiating movement and mobilization early reduced surgical stress, muscle atrophy, complications, hospital stay, and care costs. Other studies have also reported that early mobilization accelerates the functioning of the Gastrointestinal System (GIS), prevents thromboembolic complications, and speeds up recovery. To minimize complications after surgery and optimize the child's health, the Enhanced Recovery After Surgery (ERAS) protocol can be applied. These protocols, also known as "Fast-Track," were first implemented in 2001. Early mobilization is one of the most important components of the ERAS approach. According to the ERAS protocol, the patient needs to be mobilized for two hours on the day of surgery and for a total of six hours on subsequent days until discharge.

Although the benefits of early mobilization after surgery and its contribution to the recovery process are known, one study reported that early mobilization attempts were infrequent for patients after surgery (Rafeeqi and Pearson, 2021). Another study also indicated that patients need assistance with mobilization after surgical operations. At this point, nurses are key in initiating the early mobilization process to improve the quality of postoperative care. It is essential that early mobilization is initiated by the nurse, followed by encouraging the child to move independently. The surgical nurse should support the patient to achieve the highest possible level of independence and help improve their well-being.

Randomized controlled trials that comprehensively assess both physical performance and psychological comfort (pain and fear) simultaneously during mobilization in postoperative children are limited. This study is designed as a randomized controlled trial to prove the effectiveness of low-cost, easy-to-implement, and concrete play materials such as "Walking Tracks" (Mat Mats), which are distraction-based and suitable for children's developmental characteristics, in contrast to expensive and technology-based mobilization initiatives in the literature. It aims to fill the evidence gap that holistically evaluates both physical and psychological recovery. This study aims to improve both physical and psychological recovery in a holistic way by transforming mobilization in children from a "task" into a "game". The population of the study, which is planned as a randomized controlled trial, will consist of 74 children aged 4-10 years who underwent abdominal surgery in the Pediatric Surgery Department of Mersin University Hospital.

Methodology

Study Design: A randomized controlled experimental design will be employed.

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

入排标准

年龄范围
4 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Being between 4-10 years old
  • Having undergone abdominal surgery
  • Having undergone surgery under general anesthesia
  • Having received analgesics (paracetamol) after surgery
  • Having undergone initial mobilization after surgery
  • Being a volunteer to participate in the study

排除标准

  • Having undergone previous surgery
  • A parent having undergone abdominal surgery
  • The child having visual, hearing, or intellectual disabilities

研究组 & 干预措施

Walkway group

Experimental

In the experimental group, a washable/disinfectable mat with colorful figures and a target route will be placed in front of the children's beds. The child will be mobilized using this track in addition to standard parental support.

干预措施: Walkway (Other)

no intervention

No Intervention

Control Group: Mobilization will be provided with parental support as part of the clinic's routine.

结局指标

主要结局

Wong Baker Pain Scale

时间窗: 1 day

Developed in 1981 by Donna Wong and Connie Morain Baker and revised in 1983, this scale is designed to assess children's pain levels. It includes six facial expressions scored from zero to ten.

Fear Scale

时间窗: 1 day

Developed by Thurillet et al. to assess children's fears based on self-reports from children aged 4-12 years. The Turkish validity and reliability study was conducted by Tavşan et al.

次要结局

未报告次要终点

研究者

发起方
Tarsus University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra AYDIN

MSc

Tarsus University

研究点 (1)

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