- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07375511
The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases (Accelerated Re)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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. Exclusion Criteria
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: mERAS Protocol Patient Group
|
mERAS Protocol Patient Group 1. Preoperative Period: Preparation and Education Within the scope of the mERAS protocol, both the child and their family are evaluated with a holistic approach in the preoperative period and prepared for the surgical process; this process is structured in accordance with the current ERAS guidelines for pediatric applications. Education and Counseling The child and their family will receive detailed information covering the preoperative, intraoperative, and postoperative processes. The child will be educated on preparing for the surgical experience using age-appropriate audiovisual materials; the family will be informed about the basic components of the recovery process, expected outcomes, and the contributions of the ERAS protocol. In addition, regular internal training for the surgeon, nurses, and anesthesia team will be provided to increase the applicability of the protocol and team cohesion. Preoperative Interventions • Patient and Family Information: P |
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Wong-Baker Faces Pain Rating Scale
Time Frame: 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 |
7 DAY
|
|
Baxter Animated Retching Faces Scale (BARF)
Time Frame: 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).
|
7 days
|
|
Visual Thirst Scale
Time Frame: 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).
|
7 days
|
|
Children's Fear Scale
Time Frame: 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).
|
7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ÇUKUROVA ÜNİVERSTY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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