mERAS InterventionAccelerated ReNCT07375511

The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases

A study testing mERAS Protocol in people with mERAS Intervention and The ASA (American Society of Anesthesiologists) Score, run by Emel Yürük.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Who is it for?: Ages 6 to 12 years
Conditions the study is for: mERAS Intervention, The ASA (American Society of Anesthesiologists) Score, The Patient Must be Between 4 and 12 Years Old
What is being tested?: mERAS Protocol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: No sites listed yet
Study dates: 15 Dec 2026to 15 Jun 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

None listed.

About this study

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.

Conditions: mERAS Intervention, The ASA (American Society of Anesthesiologists) Score, The Patient Must be Between 4 and 12 Years Old
Being tested: mERAS Protocol
Keywords: Pediatric laparoscopic surgery, ERAS, Postoperative Recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mERAS ProtocolOther
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

Study groups in NCT07375511
Study group	Role	What they receive
mERAS Protocol Patient Group	Experimental	mERAS Protocol Patient Group Receives: Other: mERAS Protocol
Patient Group Receiving Standard Care	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Wong-Baker Faces Pain Rating Scale
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
Measured: 7-14 DAY
Baxter Animated Retching Faces Scale (BARF)
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).
Measured: 7-14 days
Visual Thirst Scale
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).
Measured: 7-14 days
Children's Fear Scale
Developed by Thurillet et al. (2022), this instrument is designed to assess children's fears based on their own self-reports (for children aged 4-12 years). A study on its validity and reliability in Turkish was conducted by Tavşan et al. (2024). The scale consists of six facial expressions. It quantifies fear on a scale from 0 to 10-with increments of two-consistent with pain-rating scales. The first facial expression indicates the absence of fear; the level of fear increases from left to right, with the sixth facial expression representing the highest level of fear. A statistically significant, very strong positive correlation was found between this Fear Scale and the Child Fear Scale (r=0.973; p<0.001). This high correlation between the two forms indicates that the child-report version is valid. The content validity index for the scale and the item-level content validity index were both found to be 0.98. A statistically significant, high level of agreement was observed between the
Measured: 7-14 days

Secondary outcomes (1)

Postoperative Recovery Scale
The Postoperative Recovery Scale (PRS) will be used in this study to assess postoperative recovery. The PRS is a multidimensional scale consisting of 23 items, developed to evaluate postoperative recovery in children aged 4-12 years through self-reporting. The items are categorized into three subdimensions: physical comfort, physical independence, and emotional state. All items are rated on a 4-point Likert-type scale (1 = "not at all," 4 = "very much"), reflecting the child's status over the previous 24 hours; higher scores indicate a less favorable level of recovery (Bramhagen et al., 2016).
In the study regarding the development of the scale, the internal consistency coefficient (Cronbach's α) for the total scale was reported as 0.83 (Bramhagen et al., 2016). For the Turkish adaptation of the PRS, the Cronbach's α coefficient for the total scale was found to be 0.84 (Kürtüncü \& Kurt, 2023). Therefore, in our study, the postoperative recove
Measured: 14-21 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202615 Jun 2027

First posted29 Jan 2026
Study start15 Dec 2026 (estimated)
Primary completion15 Jan 2027 (estimated)
Study completion15 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for mERAS InterventionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: This research was planned as a parallel-group, randomized controlled experimental study based on pre-test-post-test measurements to evaluate the effect of the Accelerated Recovery (mERAS) approach on postoperative pain, nausea-vomiting, thirst, fear, and recovery process in children undergoing pediatric laparoscopic surgery.
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07375511
Sponsor's protocol ID: ÇUKUROVA ÜNİVERSTY
Acronym: Accelerated Re
Status last verified: Oct 2026
First submitted: 24 Dec 2025
Last updated: 26 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Contribution of Accelerated Recovery (mERAS) Approach to Postoperative Recovery in Pediatric Laparoscopic Surgery Cases
ClinicalTrials.gov ID: NCT07375511
Acronym / sponsor ID: Accelerated Re / ÇUKUROVA ÜNİVERSTY
Conditions: mERAS Intervention, The ASA (American Society of Anesthesiologists) Score, The Patient Must be Between 4 and 12 Years Old
Keywords: Pediatric laparoscopic surgery, ERAS, Postoperative Recovery
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 60 participants (estimated)
Lead sponsor: Emel YürükUniversity, hospital or other
Study start: 15 Dec 2026 (estimated)
Primary completion: 15 Jan 2027 (estimated)
Study completion: 15 Jun 2027 (estimated)
First posted: 29 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: This research was planned as a parallel-group, randomized controlled experimental study based on pre-test-post-test measurements to evaluate the effect of the Accelerated Recovery (mERAS) approach on postoperative pain, nausea-vomiting, thirst, fear, and recovery process in children undergoing pediatric laparoscopic surgery.

Arm	Type	Receives
mERAS Protocol Patient Group	Experimental	Other: mERAS ProtocolmERAS Protocol Patient Group
Patient Group Receiving Standard Care	No intervention	–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.

Who may qualify

Ages: 6 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

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),

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
mERAS ProtocolmERAS 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	Other	mERAS Protocol Patient Group

Primary outcome

Wong-Baker Faces Pain Rating Scale
Time frame: 7-14 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)
Time frame: 7-14 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
Time frame: 7-14 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
Time frame: 7-14 days
Developed by Thurillet et al. (2022), this instrument is designed to assess children's fears based on their own self-reports (for children aged 4-12 years). A study on its validity and reliability in Turkish was conducted by Tavşan et al. (2024). The scale consists of six facial expressions. It quantifies fear on a scale from 0 to 10-with increments of two-consistent with pain-rating scales. The first facial expression indicates the absence of fear; the level of fear increases from left to right, with the sixth facial expression representing the highest level of fear. A statistically significant, very strong positive correlation was found between this Fear Scale and the Child Fear Scale (r=0.973; p<0.001). This high correlation between the two forms indicates that the child-report version is valid. The content validity index for the scale and the item-level content validity index were both found to be 0.98. A statistically significant, high level of agreement was observed between the

1 secondary outcome

Postoperative Recovery Scale
Time frame: 14-21 day

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing mERAS Protocol in people with mERAS Intervention and The ASA (American Society of Anesthesiologists) Score, run by Emel Yürük.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wong-Baker Faces Pain Rating Scale (time frame: 7-14 DAY). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07375511.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.