NCT06598410

Brief Summary

The study was planned as a randomized controlled experimental study to determine the effect of playing digital games and watching cartoons on the pain, fear, and anxiety levels of children during suturing in the pediatric emergency unit. The population of the study, which is planned as a randomized controlled experimental study, will consist of children between the ages of 5-10 who apply to the Trauma Unit of the Pediatric Emergency Unit of Tarsus State Hospital and undergo suturing. As a result of the Power analysis (G\*Power 3.1.9.2); effect size = 1.136, 95% confidence interval, 95% power, it was calculated that a total of 66 children, at least 22 in each group, should be included. Considering that there may be dropout and confounding variables in the research process, it was determined as 90 children in total, with 30 children in each group. Implementation Stage 1: A pool of cartoons that can be watched and digital games that can be played, suitable for the level of the child in the 5-10 age group, will be created by the researchers by taking the opinion of the relevant experts. The created children\'s cartoon and digital game pool will be sent to experts in the field (child development specialist, child psychiatrist, child nurse). Stage 2: A pilot study will be conducted with 10 children to evaluate the suitability of data collection forms, digital games and cartoons for children. Stage 3: 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 permission will be obtained from the family and verbal permission will be obtained from the child. It will be ensured that the children in all groups will have their parents with them during the procedure. Stage 4: Children who meet the sample selection criteria will be divided into 3 groups (1st study group, 2nd study group, and 3rd group control group) through a computerized programme. Stage 5: The data collection form in the research will be applied to the children in the sample group before the procedure. 6th Stage: The pain, fear and anxiety of the children in all groups before the procedure will be evaluated by the child, parent and nurse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

2 active sites

Status
completed

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 Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2025

Completed
Last Updated

January 7, 2026

Status Verified

January 1, 2026

Enrollment Period

10 months

First QC Date

September 13, 2024

Last Update Submit

January 6, 2026

Conditions

Keywords

painfearanxietyemergencypediatri

Outcome Measures

Primary Outcomes (3)

  • pain level

    Wong Baker Pain Scale: It was developed by Donna Wong and Connie Morain Baker in 1980 and adapted again in 1983 to measure the pain levels of paediatric patients. There are 6 facial expressions scored between 0-5. In the Wong-Baker Scale, there are facial expressions indicating the degree of pain increasing from 0 to 5 from left to right.

    1 hour

  • fear

    Child Fear Scale: The scale was developed by Thurillet et al. It was developed to evaluate children\'s fears based on self-report of children aged 4-12 years. The scale consists of six facial expressions. The scale grades fear with a score ranging from 0 to 10 (gradually graded two by two) consistent with pain rating scales. The first facial expression shows that there is no fear, the fear increases as you go from right to left, and the sixth facial expression shows that the level of fear is the highest. A statistically significant positive and very high correlation was obtained between the Fear Scale and the Child Fear Scale (r=0.973; p;0.001). The high correlation value between the two forms shows that the child form is valid.

    1 hour

  • anxiety

    Child Anxiety Scale-Dispositional Scale (CAS-D): It was developed by Ersig et al. (2013) to measure the anxiety levels of children aged 4-10 years. The CAS-D scale is shaped like a thermometer with a light bulb at the bottom and horizontal lines with intervals going upwards. In this scale for children aged 4-10 years, children are asked 'Imagine that all your anxious or nervous feelings are at the bulb or bottom of the thermometer' or 'If you are a little worried or nervous, the feelings may go up a little on the thermometer. If you are very, very anxious or nervous, emotions can go all the way to the top. Put a line on the thermometer showing how anxious or nervous you are'. In order to measure state anxiety (CAS-D), the child is asked to tick how he/she feels 'right now'. The score can range from 0-10.

    1 hour

Study Arms (3)

Digital Gaming

EXPERIMENTAL

Children will play digital games during suturing in the Paediatric Emergency Unit

Other: Digital gaming

Watching Cartoon

EXPERIMENTAL

Children will watching cartoon during suturing in the Paediatric Emergency Unit

Other: watching cartoon

Control

NO INTERVENTION

Children will not be subjected to any form of distraction

Interventions

Children in this group will be allowed to play digital games 5 minutes before the procedure starts. They will continue to play the game during the procedure.

Digital Gaming

Children in this group will be shown a cartoon film 5 minutes before the procedure. They will continue to play the game during the procedure.

Watching Cartoon

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between 5-10 years old
  • Suture removal will be applied
  • Number of sutures 3 or more
  • volunteering to participate in the study.

You may not qualify if:

  • No previous suturing procedure
  • Suturing to be applied to the hand, arm area
  • The child has visual, hearing and intellectual disabilities
  • Having a physical problem that prevents them from playing digital games

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Tarsus University

Tarsus, Turkey (Türkiye)

Location

Related Publications (9)

  • Duzkaya DS, Bozkurt G, Ulupinar S, Uysal G, Ucar S, Uysalol M. The Effect of a Cartoon and an Information Video About Intravenous Insertion on Pain and Fear in Children Aged 6 to 12 Years in the Pediatric Emergency Unit: A Randomized Controlled Trial. J Emerg Nurs. 2021 Jan;47(1):76-87. doi: 10.1016/j.jen.2020.04.011. Epub 2020 Jul 18.

  • Topan, A., Bayram, D. ve Ayyıldız, T. K. (2019) Pediatrik Acil Servise Başvuran 0- 18 Yaş Grubu Olgular: Retrospektif İnceleme. İzmir Kâtip Çelebi Üniversitesi Sağlık Bilimleri Fakültesi Dergisi. Vol. 4(3-1), ss. 300-305.

    RESULT
  • Yıldız S. Acile başvuran çocuk ve aileye psikososyal yaklaşım. Atatürk Üniversitesi Hemşirelik Yüksekokulu Dergisi. 2006; 9(3); 69-76

    RESULT
  • Thurillet S, Bahans C, Wood C, Bougnard S, Labrunie A, Messager V, Toniolo J, Beloni P, Fourcade L. Psychometric properties of a self-assessment fear scale in children aged 4 to 12 years. Scary Scale. J Pediatr Nurs. 2022 Jul-Aug;65:108-115. doi: 10.1016/j.pedn.2022.02.020. Epub 2022 Mar 14.

  • HasasnTehrani, T., Pakzad, A., Mohammadi, F., Tapak, L., &Azmamoun, H. (2022). Effect of Pre-endoscopyPreparation Program on Children'sAnxietyandParentalSatisfaction: A Clinical Trial Study. EvidenceBasedCare, 11(4), 48-54.

    RESULT
  • Guerrero-Marquez G, Martinez-Serrano A, Miguez-Navarro C, Lopez-Miron JA, Espartosa-Larrayad M. [Knowledge of nurses about medication doses at pediatric urgency departament]. Enferm Clin. 2016 Jul-Aug;26(4):213-9. doi: 10.1016/j.enfcli.2016.04.009. Epub 2016 Jun 11. Spanish.

  • Chen YJ, Cheng SF, Lee PC, Lai CH, Hou IC, Chen CW. Distraction using virtual reality for children during intravenous injections in an emergency department: A randomised trial. J Clin Nurs. 2020 Feb;29(3-4):503-510. doi: 10.1111/jocn.15088. Epub 2019 Dec 4.

  • Capua T, Kama ZB, Rimon A. The influence of an accredited pediatric emergency medicine program on the management of pediatric pain and anxiety. Isr J Health Policy Res. 2018 Mar 21;7(1):17. doi: 10.1186/s13584-018-0211-6.

  • Abuqamar M, Arabiat DH, Holmes S. Parents' Perceived Satisfaction of Care, Communication and Environment of the Pediatric Intensive Care Units at a Tertiary Children's Hospital. J Pediatr Nurs. 2016 May-Jun;31(3):e177-84. doi: 10.1016/j.pedn.2015.12.009. Epub 2016 Jan 20.

MeSH Terms

Conditions

PainAnxiety DisordersEmergencies

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersDisease AttributesPathologic Processes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 19, 2024

Study Start

July 1, 2024

Primary Completion

April 29, 2025

Study Completion

April 29, 2025

Last Updated

January 7, 2026

Record last verified: 2026-01

Locations