NCT07404163

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
7mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

February 4, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

February 4, 2026

Last Update Submit

February 4, 2026

Conditions

PainFearChildrenSurgeryMobilization

Keywords

painFearChildrensurgeryMobilization

Outcome Measures

Primary Outcomes (2)

  • Wong Baker Pain Scale

    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.

    1 day

  • Fear Scale

    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.

    1 day

Study Arms (2)

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.

Other: Walkway

no intervention

NO INTERVENTION

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

Interventions

WalkwayOTHER

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.

Walkway group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tarsus University

Mersin, Turkey (Türkiye)

Location

Related Publications (8)

  • Tazreean, R., Nelson, G., & Twomey, R. (2021). Early mobilization in enhanced recovery after surgery pathways: current evidence and recent advancements. Journal of Comparative Effectiveness Research, 11(2), 121-129.

    BACKGROUND

  • Wijk, L. (2022). Early mobilization and impact on recovery. In The ERAS® Society Handbook for Obstetrics & Gynecology (pp. 177-192). Academic Press.

    BACKGROUND

  • Townsend, C. M., Beauchamp, R. D., Evers, B. M., & Mattox, K. L. (2022). Sabiston textbook of surgery: The biological basis of modern surgical practice (21. baskı). Elsevier.

    BACKGROUND

  • Holcomb, G. W., Murphy, J. P., & St. Peter, S. D. (2020). Holcomb and Ashcraft's pediatric surgery (7. baskı). Elsevier.

    BACKGROUND

  • Kırtıl, İ., Kanan, N., & Karip, A. B. (2023). Effects of a mobilization program applied to bariatric surgery patients on preventing gastrointestinal complications: a quasi-experimental study. Obesity Surgery, 33(6), 1820-1830.

    BACKGROUND

  • Rafeeqi, T., & Pearson, E. G. (2021). Enhanced recovery after surgery in children. Translational gastroenterology and hepatology, 6, 46. https://doi.org/10.21037/tgh-20-188

    BACKGROUND

  • Akdağ, Y. M. (2019). Akut apendisit ameliyatı olan 6-12 yaş grubu çocukların postoperatif dönemde çevre oyunu ile mobilizasyonunun korku ve ağrı düzeyine etkisi (Yüksek lisans tezi). İstanbul Okan Üniversitesi.

    BACKGROUND

  • Daldaban, F. N. (2023). Erken mobilizasyon eğitiminin abdominal cerrahi sonrası hareketlilik, ağrı ve konfor üzerine etkisi (Yüksek lisans tezi). Doğu Akdeniz Üniversitesi.

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 11, 2026

Study Start

February 4, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

TU(1)