ChildNCT07428421
The Effect of Supporting the Incision Site With Toys During Mobilization in Children Aged 4-10 Years Undergoing Abdominal Surgery
A study testing Toy Group in people with Child, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial summary
Aim: The aim of this study is to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery. Method: The study was a randomised controlled trial. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Child
- What is being tested?
- Toy Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 15 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
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 4 and 10 years
- Having undergone abdominal surgery
- Having undergone surgery under general anesthesia
- Having received a single dose of analgesic (paracetamol) after surgery
- Having undergone initial mobilization after surgery
- Volunteering to participate in the study
Who cannot join
- Previous surgical intervention
- Major surgery
- Chronic illness
- The child has visual, hearing, and mental disabilities
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yusuf Kızılkaya contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tarsus University
Mersin
Duygu SÖNMEZ DÜZKAYA, PhD, duygusduzkaya@tarsus.edu.tr
About this study
Official title: The Effect of Supporting the Incision Site With Toys During Mobilization on Pain and Fear Levels in Children Aged 4-10 Years Undergoing Abdominal Surgery
Aim: The aim of this study is to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery. Method: The study was a randomised controlled trial. The study sample consisted of 74 children (Toy: 37, control: 37) who has undergone abdominal surgery between March 2026 and December 2026 at the Mersin University Hospital Pediatric surgery department. The data collection tools used will be the Children Information Form, Wong Baker Pain Scale , Fear scale. In the intervention group, toy will be used after surgery, while the control group will receive routine care. The chils' pain and fear levels will be assessed by the nurse before and after the procedure.
Read the detailed description
The study will be conducted as a randomized controlled trial to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery.
Materials and Methods Setting The research will be conducted at the Pediatric Surgery Department of Mersin University Hospital between March and December 2026. The Pediatric Surgery Department is where elective day surgeries and emergency surgical interventions are performed, and where pre- and post-operative care is provided.
Sample When determining the sample size for the study, the scientific study titled "The Effect of Mobilization with Environmental Play on Fear and Pain Levels in the Postoperative Period of Children Aged 6-12 Years Who Underwent Acute Appendectomy" by Akdağ (2019), based on literature reviews to determine the sample size for effect size, was used as a basis. According to the study, the Power analysis (G*Power 3.1.9.2) resulted in an effect size of 0.896, a 95% confidence interval, and a 95% power, requiring a total of 68 children, with at least 34 in each group. Considering the possibility of dropouts and confounding variables during the research process, a total of 74 children were determined, with 37 children in each group.
Data Collection The necessary ethics committee and institutional approvals will be obtained before starting the research.
- Phase: Data collection forms to be used prior to the research will be pilot tested with 10 children to assess the suitability of the plush toy selected for support.
- Phase: The children and family members in the sample group will be informed about how the application will be carried out and about the research, and written consent will be obtained from the family and verbal consent from the child.
- Phase: Children meeting the sample selection criteria will be randomly and equally distributed into two groups (1st study group and 2nd control group) using a computer program to ensure randomization. "(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html)".
- Phase: The pain and fear levels of children in all groups prior to mobilization will be assessed by the child, parent, and nurse. The child's vital signs will be recorded by the nurse prior to mobilization. In this phase:
- Study group: Children in this group will be supported with a plush toy immediately before the incision sites are treated and will continue to be supported throughout mobilization. When the child is transferred to the hospital bed, the support with the plush toy will be discontinued.
- Control group: Children in this group will receive the parent support that is routine in the clinic.
- Step: After mobilization, the child's pain and fear levels will be assessed and recorded by the child, parent, and nurse. After mobilization, the nurse will record the child's vital signs.
- Step: The data obtained will be analyzed and reported.
STATISTICAL ANALYSIS The Statistical Package for Social Sciences (SPSS) version 25.0 will be used to evaluate the data obtained from the research. Descriptive statistics such as frequency, percentage, and arithmetic mean will be used in the analysis of sociodemographic data. For data with a normal distribution, an independent t-test will be used to compare quantitative data between two independent groups, while analysis of variance will be used for repeated measurements when comparing more than two dependent groups. If a difference is found, Bonferroni will be used to identify the group causing the difference. For non-normally distributed data, the Mann Whitney U test will be applied to compare quantitative data between two independent groups, and the Friedman test will be applied when comparing more than two dependent groups. If a difference is found, the adjusted Bonferroni test will be used to identify the group causing the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in the inter-observer agreement analysis. In addition, at the end of the study, the adequacy of the sample size will be tested with a post-hoc power analysis. The statistical significance level will be set at p<.05.
- Conditions
- Child
- Being tested
- Toy Group
- Keywords
- Abdominal Surgery, pediatric, nursing, toy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toy GroupOther
Children in this group will be supported with a plush toy immediately before the incision sites are processed and will continue to be supported throughout mobilization. When the child is transferred to the hospital bed, the support with the plush toy will be discontinued. Children in this group will receive parental support as part of the clinic's routine.
| Study group | Role | What they receive |
|---|---|---|
| Toy Group | Experimental | The incision sites of children in this group will be supported with a plush toy immediately before the procedure begins and will continue to be supported throughout mobilization. When the patient is transferred to the hospital bed, the support with the plush toy will be discontinued. Receives: Other: Toy Group |
| Control Group | No intervention | Children in this group will receive 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.
Children Information Form
The form, prepared in line with the literature, consists of 24 questions regarding the sociodemographic characteristics of children. A 3-point Likert-type observation form created by the researcher will be used in this form to evaluate children's participation in the mobilization process. Scoring is categorized as follows: '3: Willing/Active Participation', '2: Reluctant/Variable Participation', and '1: Unwilling/Resistant'. The researcher observed the child's verbal and behavioral responses during mobilization preparation and the walk and assigned the relevant score.
Measured: 1 day
Wong-Baker Pain Scale
Developed in 1981 by Donna Wong and Connie Morain Baker to assess children's pain levels, it was revised in 1983. There are six facial expressions scored from zero to ten. The Wong-Baker Scale features faces that show increasing pain intensity from zero to six, moving from left to right.
Measured: 1 day
Fear Scale
Thurillet et al. (2022) developed this scale to assess children's fears based on self-reports from children aged 4-12. The Turkish validity and reliability study was conducted by Tavşan et al. (2024). The scale consists of six facial expressions. The scale rates fear on a scale ranging from 0 to 10 (rated incrementally in twos), consistent with pain rating scales. The first facial expression indicates no fear, while fear increases as one moves from right to left, with the sixth facial expression indicating the highest level of fear. A statistically significant, very high positive correlation was found between the Fear Scale and the Children's Fear Scale (r=0.973; p<0.001). The high correlation value between the two forms indicates that the children's form is valid. The scale's content validity index and item content validity index values were found to be 0.98. A very good level of statistically significant agreement was found between the Fear Scale and the Children's Fear Scale (Kappa
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 posted23 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for ChildStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Sonmez Duzkaya, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07428421
- Sponsor's protocol ID
- 2026/03
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kwekkeboom KL, Gretarsdottir E. Systematic review of relaxation interventions for pain. J Nurs Scholarsh. 2006;38(3):269-77. doi: 10.1111/j.1547-5069.2006.00113.x.
PubMed 17044345Jones RA, Merkle S, Ruvalcaba L, Ashton P, Bailey C, Lopez M. Nurse-Led Mobility Program: Driving a Culture of Early Mobilization in Medical-Surgical Nursing. J Nurs Care Qual. 2020 Jan/Mar;35(1):20-26. doi: 10.1097/NCQ.0000000000000404.
PubMed 30889084Gürsoy, A. (2024). Video destekli erken mobilizasyon eğitiminin abdominal cerrahi sonrası hastaların mobilizasyon durumuna ve mobilizasyon ile ilişkili ölçütlere etkisi (doktora tezi). Karadeniz Teknik Üniversitesi.
Gıynaş, T., Önel, A. E., Küçük, S., Uğur, S., & Yardımcı, F. An Investigation of Using Non-Pharmacological Methods in Pain Management in Postoperative Period in Children: A Systematic Review. Bilecik Şeyh Edebali Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 2(3), 172-190.
Daldaban, F. N. (2023), Erken mobilizasyon eğitiminin abdominal cerrahi sonrası hareketlilik, ağrı ve konfor üzerine etkisi (yüksek lisans tezi). Doğu Akdeniz Üniversitesi.
Çamok, G. (2021). Yoğun bakım ünitesinde entübe hastaların erken mobilizasyonu ve erken mobilizasyonun solunum örüntüsü ile hasta hemodinamisine etkileri (yüksek lisans tezi). İstanbul Okan Üniversitesi.
Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.
PubMed 27354454Christiaens, G. (2003). Independent nursing interventions for pain management. Home health care management & practice, 15(3), 212-214.
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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supporting the Incision Site With Toys During Mobilization on Pain and Fear Levels in Children Aged 4-10 Years Undergoing Abdominal Surgery
- ClinicalTrials.gov ID
- NCT07428421
- Acronym / sponsor ID
- 2026/03
- Conditions
- Child
- Keywords
- Abdominal Surgery, pediatric, nursing, toy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 23 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.
Aim: The aim of this study is to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery. Method: The study was a randomised controlled trial. The study sample consisted of 74 children (Toy: 37, control: 37) who has undergone abdominal surgery between March 2026 and December 2026 at the Mersin University Hospital Pediatric surgery department. The data collection tools used will be the Children Information Form, Wong Baker Pain Scale , Fear scale. In the intervention group, toy will be used after surgery, while the control group will receive routine care. The chils' pain and fear levels will be assessed by the nurse before and after the procedure.
Detailed description
The study will be conducted as a randomized controlled trial to determine the effect of supporting the wound area with a toy during mobilization on pain and fear in children undergoing abdominal surgery.
Materials and Methods Setting The research will be conducted at the Pediatric Surgery Department of Mersin University Hospital between March and December 2026. The Pediatric Surgery Department is where elective day surgeries and emergency surgical interventions are performed, and where pre- and post-operative care is provided.
Sample When determining the sample size for the study, the scientific study titled "The Effect of Mobilization with Environmental Play on Fear and Pain Levels in the Postoperative Period of Children Aged 6-12 Years Who Underwent Acute Appendectomy" by Akdağ (2019), based on literature reviews to determine the sample size for effect size, was used as a basis. According to the study, the Power analysis (G*Power 3.1.9.2) resulted in an effect size of 0.896, a 95% confidence interval, and a 95% power, requiring a total of 68 children, with at least 34 in each group. Considering the possibility of dropouts and confounding variables during the research process, a total of 74 children were determined, with 37 children in each group.
Data Collection The necessary ethics committee and institutional approvals will be obtained before starting the research.
- Phase: Data collection forms to be used prior to the research will be pilot tested with 10 children to assess the suitability of the plush toy selected for support.
- Phase: The children and family members in the sample group will be informed about how the application will be carried out and about the research, and written consent will be obtained from the family and verbal consent from the child.
- Phase: Children meeting the sample selection criteria will be randomly and equally distributed into two groups (1st study group and 2nd control group) using a computer program to ensure randomization. "(http://www1.assumption.edu/users/avadum/applets/RandAssign/GroupGen.html)".
- Phase: The pain and fear levels of children in all groups prior to mobilization will be assessed by the child, parent, and nurse. The child's vital signs will be recorded by the nurse prior to mobilization. In this phase:
- Study group: Children in this group will be supported with a plush toy immediately before the incision sites are treated and will continue to be supported throughout mobilization. When the child is transferred to the hospital bed, the support with the plush toy will be discontinued.
- Control group: Children in this group will receive the parent support that is routine in the clinic.
- Step: After mobilization, the child's pain and fear levels will be assessed and recorded by the child, parent, and nurse. After mobilization, the nurse will record the child's vital signs.
- Step: The data obtained will be analyzed and reported.
STATISTICAL ANALYSIS The Statistical Package for Social Sciences (SPSS) version 25.0 will be used to evaluate the data obtained from the research. Descriptive statistics such as frequency, percentage, and arithmetic mean will be used in the analysis of sociodemographic data. For data with a normal distribution, an independent t-test will be used to compare quantitative data between two independent groups, while analysis of variance will be used for repeated measurements when comparing more than two dependent groups. If a difference is found, Bonferroni will be used to identify the group causing the difference. For non-normally distributed data, the Mann Whitney U test will be applied to compare quantitative data between two independent groups, and the Friedman test will be applied when comparing more than two dependent groups. If a difference is found, the adjusted Bonferroni test will be used to identify the group causing the difference. Chi-square analysis will be applied to test the relationship between categorical variables. Cohen's Kappa Test will be applied in the inter-observer agreement analysis. In addition, at the end of the study, the adequacy of the sample size will be tested with a post-hoc power analysis. The statistical significance level will be set at p<.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toy Group | Experimental | Other: Toy GroupThe incision sites of children in this group will be supported with a plush toy immediately before the procedure begins and will continue to be supported throughout mobilization. When the patient is transferred to the hospital bed, the support with the plush toy will be discontinued. |
| Control Group | No intervention | –Children in this group will receive parental support as part of the clinic's routine. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged between 4 and 10 years
- Having undergone abdominal surgery
- Having undergone surgery under general anesthesia
- Having received a single dose of analgesic (paracetamol) after surgery
- Having undergone initial mobilization after surgery
Key exclusion criteria (4 listed)
- Previous surgical intervention
- Major surgery
- Chronic illness
- The child has visual, hearing, and mental 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 |
|---|---|---|
| Toy GroupChildren in this group will be supported with a plush toy immediately before the incision sites are processed and will continue to be supported throughout mobilization. When the child is transferred to the hospital bed, the support with the plush toy will be discontinued. Children in this group will receive parental support as part of the clinic's routine. | Other | Toy Group |
Primary outcome
Children Information Form
Time frame: 1 day
The form, prepared in line with the literature, consists of 24 questions regarding the sociodemographic characteristics of children. A 3-point Likert-type observation form created by the researcher will be used in this form to evaluate children's participation in the mobilization process. Scoring is categorized as follows: '3: Willing/Active Participation', '2: Reluctant/Variable Participation', and '1: Unwilling/Resistant'. The researcher observed the child's verbal and behavioral responses during mobilization preparation and the walk and assigned the relevant score.
Wong-Baker Pain Scale
Time frame: 1 day
Developed in 1981 by Donna Wong and Connie Morain Baker to assess children's pain levels, it was revised in 1983. There are six facial expressions scored from zero to ten. The Wong-Baker Scale features faces that show increasing pain intensity from zero to six, moving from left to right.
Fear Scale
Time frame: 1 day
Thurillet et al. (2022) developed this scale to assess children's fears based on self-reports from children aged 4-12. The Turkish validity and reliability study was conducted by Tavşan et al. (2024). The scale consists of six facial expressions. The scale rates fear on a scale ranging from 0 to 10 (rated incrementally in twos), consistent with pain rating scales. The first facial expression indicates no fear, while fear increases as one moves from right to left, with the sixth facial expression indicating the highest level of fear. A statistically significant, very high positive correlation was found between the Fear Scale and the Children's Fear Scale (r=0.973; p<0.001). The high correlation value between the two forms indicates that the children's form is valid. The scale's content validity index and item content validity index values were found to be 0.98. A very good level of statistically significant agreement was found between the Fear Scale and the Children's Fear Scale (Kappa
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 23 Feb 2026.
- Background: PubMed 17044345Kwekkeboom KL, Gretarsdottir E. Systematic review of relaxation interventions for pain. J Nurs Scholarsh. 2006;38(3):269-77. doi: 10.1111/j.1547-5069.2006.00113.x.
- Results publication: PubMed 30889084Jones RA, Merkle S, Ruvalcaba L, Ashton P, Bailey C, Lopez M. Nurse-Led Mobility Program: Driving a Culture of Early Mobilization in Medical-Surgical Nursing. J Nurs Care Qual. 2020 Jan/Mar;35(1):20-26. doi: 10.1097/NCQ.0000000000000404.
- Results publicationGürsoy, A. (2024). Video destekli erken mobilizasyon eğitiminin abdominal cerrahi sonrası hastaların mobilizasyon durumuna ve mobilizasyon ile ilişkili ölçütlere etkisi (doktora tezi). Karadeniz Teknik Üniversitesi.
- Results publicationGıynaş, T., Önel, A. E., Küçük, S., Uğur, S., & Yardımcı, F. An Investigation of Using Non-Pharmacological Methods in Pain Management in Postoperative Period in Children: A Systematic Review. Bilecik Şeyh Edebali Üniversitesi Sağlık Bilimleri Fakültesi Dergisi, 2(3), 172-190.
- Results publicationDaldaban, F. N. (2023), Erken mobilizasyon eğitiminin abdominal cerrahi sonrası hareketlilik, ağrı ve konfor üzerine etkisi (yüksek lisans tezi). Doğu Akdeniz Üniversitesi.
- Results publicationÇamok, G. (2021). Yoğun bakım ünitesinde entübe hastaların erken mobilizasyonu ve erken mobilizasyonun solunum örüntüsü ile hasta hemodinamisine etkileri (yüksek lisans tezi). İstanbul Okan Üniversitesi.
- Results publication: PubMed 27354454Cote CJ, Wilson S; AMERICAN ACADEMY OF PEDIATRICS; AMERICAN ACADEMY OF PEDIATRIC DENTISTRY. Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016. Pediatrics. 2016 Jul;138(1):e20161212. doi: 10.1542/peds.2016-1212.
- Results publicationChristiaens, G. (2003). Independent nursing interventions for pain management. Home health care management & practice, 15(3), 212-214.
- Results publicationAkdağ, 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.
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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.
Yusuf Kızılkaya contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toy Group in people with Child, 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 4 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: looking for participants now, as of the sponsor's last update on 23 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?
Contact Duygu SÖNMEZ DÜZKAYA, PhD (2200 ext. +903246000033, duygusduzkaya@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children Information Form (time frame: 1 day). The study lists 3 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 NCT07428421, which also lists 9 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 23 Feb 2026.