PainNCT07404163
Walkway Used in Postoperative Mobilization
A study testing Walkway in people with Pain and Fear, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- What is being tested?
- Walkway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Feb 2026to 30 Dec 2026
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Having undergone previous surgery
- A parent having undergone abdominal surgery
- The child having visual, hearing, or intellectual disabilities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Walkway Used in Postoperative Mobilization on Children's Pain, Fear, and Time to Initiate Mobilization
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.
Read the detailed description
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.
Setting \& Sample: The study will be conducted at Mersin University Hospital Pediatric Surgery Service. A total of 74 children (37 experiment, 37 control) will be recruited based on power analysis.
Randomization: Stratified block randomization will be used based on Surgical Technique (Open vs. Laparoscopic) and Developmental Stage (4-6 years vs. 7-10 years) to ensure group homogeneity.
Intervention: The experimental group will use a "Walkway" mat featuring colorful figures and a target route placed in front of their beds. The control group will receive standard parent-supported mobilization.
Data Collection Tools: * Introductory Information Form
Wong-Baker FACES Pain Rating Scale
Children's Fear Scale
Vital Signs Tracking Form
Procedure: A pilot study with 10 children will precede the main study. Mobilization for all participants will begin 30-60 minutes after a standard dose of analgesic (paracetamol) to ensure comfort. Pain and fear will be assessed by the child, parent, and nurse simultaneously before and after mobilization.
Statistical Analysis Data will be analyzed using SPSS, employing descriptive statistics, t-tests, or Mann-Whitney U tests for group comparisons. Consistency between child, parent, and nurse assessments will be measured using the Cohen's Kappa Test.
Expected Outcomes It is hypothesized that turning mobilization into a game via the walkway will significantly reduce the children's fear and pain levels while shortening the time to initiate the first step. This study aims to provide nursing evidence for holistic, low-cost, and developmentally appropriate pediatric postoperative care.
- Conditions
- Pain, Fear, Children, Surgery, Mobilization
- Being tested
- Walkway
- Keywords
- pain, Fear, Children, surgery, Mobilization
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Walkway |
| no intervention | No intervention | Control Group: Mobilization will be provided with parental support as part of the clinic's routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start4 Feb 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PainStudies 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
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra AYDIN, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07404163
- Sponsor's protocol ID
- 2026-04
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tazreean R, Nelson G, Twomey R. Early mobilization in enhanced recovery after surgery pathways: current evidence and recent advancements. J Comp Eff Res. 2022 Feb;11(2):121-129. doi: 10.2217/cer-2021-0258. Epub 2022 Jan 20.
PubMed 35045757Wijk, L. (2022). Early mobilization and impact on recovery. In The ERAS® Society Handbook for Obstetrics & Gynecology (pp. 177-192). Academic Press.
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.
Holcomb, G. W., Murphy, J. P., & St. Peter, S. D. (2020). Holcomb and Ashcraft's pediatric surgery (7. baskı). Elsevier.
Kirtil I, Kanan N, Karip AB. Effects of a Mobilization Program Applied to Bariatric Surgery Patients on Preventing Gastrointestinal Complications: a Quasi-Experimental Study. Obes Surg. 2023 Jun;33(6):1820-1830. doi: 10.1007/s11695-023-06609-z. Epub 2023 Apr 21.
PubMed 37084024Rafeeqi T, Pearson EG. Enhanced recovery after surgery in children. Transl Gastroenterol Hepatol. 2021 Jul 25;6:46. doi: 10.21037/tgh-20-188. eCollection 2021.
PubMed 34423167Akdağ, 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.
Daldaban, F. N. (2023). Erken mobilizasyon eğitiminin abdominal cerrahi sonrası hareketlilik, ağrı ve konfor üzerine etkisi (Yüksek lisans tezi). Doğu Akdeniz Üniversitesi.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Walkway Used in Postoperative Mobilization on Children's Pain, Fear, and Time to Initiate Mobilization
- ClinicalTrials.gov ID
- NCT07404163
- Acronym / sponsor ID
- 2026-04
- Conditions
- Pain, Fear, Children, Surgery, Mobilization
- Keywords
- pain, Fear, Children, surgery, Mobilization
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Feb 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.
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.
Detailed description
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.
Setting \& Sample: The study will be conducted at Mersin University Hospital Pediatric Surgery Service. A total of 74 children (37 experiment, 37 control) will be recruited based on power analysis.
Randomization: Stratified block randomization will be used based on Surgical Technique (Open vs. Laparoscopic) and Developmental Stage (4-6 years vs. 7-10 years) to ensure group homogeneity.
Intervention: The experimental group will use a "Walkway" mat featuring colorful figures and a target route placed in front of their beds. The control group will receive standard parent-supported mobilization.
Data Collection Tools: * Introductory Information Form
Wong-Baker FACES Pain Rating Scale
Children's Fear Scale
Vital Signs Tracking Form
Procedure: A pilot study with 10 children will precede the main study. Mobilization for all participants will begin 30-60 minutes after a standard dose of analgesic (paracetamol) to ensure comfort. Pain and fear will be assessed by the child, parent, and nurse simultaneously before and after mobilization.
Statistical Analysis Data will be analyzed using SPSS, employing descriptive statistics, t-tests, or Mann-Whitney U tests for group comparisons. Consistency between child, parent, and nurse assessments will be measured using the Cohen's Kappa Test.
Expected Outcomes It is hypothesized that turning mobilization into a game via the walkway will significantly reduce the children's fear and pain levels while shortening the time to initiate the first step. This study aims to provide nursing evidence for holistic, low-cost, and developmentally appropriate pediatric postoperative care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walkway group | Experimental | Other: WalkwayIn 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. |
| no intervention | No intervention | –Control Group: Mobilization will be provided with parental support as part of the clinic's routine. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Having undergone previous surgery
- A parent having undergone abdominal surgery
- The child having visual, hearing, or intellectual disabilities
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 |
|---|---|---|
| WalkwayIn the experimental group, a washable/disinfectable mat with colorful figures and a target route will be placed in front of the children's beds. | Other | Walkway group |
Primary outcome
Wong Baker Pain Scale
Time frame: 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
Time frame: 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.
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 11 Feb 2026.
- Background: PubMed 35045757Tazreean R, Nelson G, Twomey R. Early mobilization in enhanced recovery after surgery pathways: current evidence and recent advancements. J Comp Eff Res. 2022 Feb;11(2):121-129. doi: 10.2217/cer-2021-0258. Epub 2022 Jan 20.
- BackgroundWijk, L. (2022). Early mobilization and impact on recovery. In The ERAS® Society Handbook for Obstetrics & Gynecology (pp. 177-192). Academic Press.
- BackgroundTownsend, 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.
- BackgroundHolcomb, G. W., Murphy, J. P., & St. Peter, S. D. (2020). Holcomb and Ashcraft's pediatric surgery (7. baskı). Elsevier.
- Background: PubMed 37084024Kirtil I, Kanan N, Karip AB. Effects of a Mobilization Program Applied to Bariatric Surgery Patients on Preventing Gastrointestinal Complications: a Quasi-Experimental Study. Obes Surg. 2023 Jun;33(6):1820-1830. doi: 10.1007/s11695-023-06609-z. Epub 2023 Apr 21.
- Background: PubMed 34423167Rafeeqi T, Pearson EG. Enhanced recovery after surgery in children. Transl Gastroenterol Hepatol. 2021 Jul 25;6:46. doi: 10.21037/tgh-20-188. eCollection 2021.
- BackgroundAkdağ, 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.
- BackgroundDaldaban, F. N. (2023). Erken mobilizasyon eğitiminin abdominal cerrahi sonrası hareketlilik, ağrı ve konfor üzerine etkisi (Yüksek lisans tezi). Doğu Akdeniz Üniversitesi.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walkway in people with Pain and Fear, run by Tarsus University at 1 site in Turkey (Türkiye).
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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Pain Scale (time frame: 1 day). The study lists 2 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 NCT07404163, which also lists 8 linked publications.
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 11 Feb 2026.