The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Wong-Baker Faces Pain Rating Scale
研究概览
简要总结
Pediatric laparoscopic surgery is a gold standard across all ages, offering benefits like smaller incisions, faster recovery, and better cosmetic outcomes. However, because children require more precise hemodynamic and respiratory management than adults, specialized perioperative care is essential. This study aims to evaluate the impact of a multidisciplinary Enhanced Recovery After Surgery (ERAS) approach on children aged 4-12, specifically measuring its effect on postoperative pain, nausea, thirst, fear levels, and the overall recovery process.
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be between 4 and 12 years old,
- •The ASA (American Society of Anesthesiologists) score must be 1 or 2,
- •The parent(s) must be cognitively competent to give consent.
排除标准
- •The child/parents must refuse to participate in the study,
- •The presence of comorbidities that interfere with mobilization or oral feeding (which impairs the pain score),
- •Chronic pain syndrome or regular opioid use,
- •Previous major surgery in the same area (which may affect healing and pain experience).
研究组 & 干预措施
mERAS Protocol Patient Group
mERAS Protocol Patient Group
干预措施: mERAS Protocol (Other)
Patient Group Receiving Standard Care
Preoperative Period: Within the scope of standard care, comprehensive education is not provided to patients and their families; only informed relatives are consulted to obtain surgical consent. During this period, patients' comorbidities are evaluated, and necessary medical treatments are applied. However, nutritional risk screening, which is emphasized in the literature, especially in pediatric surgery, is not routinely performed. While prophylactic antibiotic administration is aimed at, there is no standardized protocol for nausea-vomiting and pain management; treatment is carried out at the physician's discretion. Routine bowel preparation in accordance with current guidelines is not performed.
结局指标
主要结局
Wong-Baker Faces Pain Rating Scale
时间窗: 7 DAY
Wong-Baker Faces Pain Rating Scale (Appendix 2): This is a visual self-assessment tool developed to evaluate the physical pain levels of individuals aged three years and older based on their own reports. The scale, consisting of six facial expressions, is scored from 0 = "no pain" to 10 = "very severe pain," and the child is asked to choose the face that best expresses the pain they are experiencing. It is a frequently used, valid, and understandable method for evaluating acute pain, especially in children who have difficulty verbally describing pain (Wong \& Baker, 1988; Cohen et al., 2008). In this study, the postoperative pain levels of all children in the 4-12 age group will be evaluated using the Wong-Baker Faces Pain Rating Scale. In each measurement, the facial expressions will be explained to the children according to the standard instructions of the scale, and they will be asked to choose the face that best reflects the pain they are experiencing. The visual form of the scale
Baxter Animated Retching Faces Scale (BARF)
时间窗: 7 days
The Baxter Animated Retching Faces (BARF) Scale, developed by Baxter et al., is a self-report tool that assesses the severity of nausea using six-stage visual facial expressions ranging from "no nausea" to "severe nausea/vomiting." The faces on the scale are ordered to represent increasing levels of nausea (Baxter et al., 2011; Şişman et al., 2016).
Visual Thirst Scale
时间窗: 7 days
Visual Thirst Scale: The Visual Analog Scale (VAS) will be used to assess the severity of thirst in the postoperative period. On this scale, a value of 0 represents "no thirst" and a value of 10 represents "the most severe thirst the patient has ever felt." This approach is consistent with the method used by Conchon and Fonseca in their perioperative thirst studies to quantitatively assess the subjective severity of thirst (Conchon \& Fonseca, 2015).
Children's Fear Scale
时间窗: 7 days
Children's Fear Scale: by McMurtry et al. (2011), the Children's Fear Scale is a visual self-assessment scale consisting of five facial expressions, scored between "no fear" (0) and "very frightened facial expression" (4), used to assess the level of fear experienced by children during medical procedures. The adaptation and validity-reliability study of the scale into Turkish was carried out by Gerçeker et al. (2018). No permission is required for clinical and research use of this scale (Children's Fear Scale - https://www.uoguelph.ca/pphc/childrens-fear-scale).
次要结局
未报告次要终点
研究者
Emel Yürük
ASSISTANT PROFESSOR
Cukurova University