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Starting soon Not applicable

The Effect of Using a Stress Ball and Watching Cartoons on Fear and Pain Levels During Enemas in Children Aged 6-12

NCT07754136 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-08-10

Condition(s) studied

Pediatric Emergency Care

Investigational drug(s) / intervention(s)

Cartoon watching groupStress ball group

Cartoon watching group: In addition to the standard clinical procedure, children in the cartoon-watching group will be shown an age-appropriate cartoon one minute before the procedure begins, and they will be encouraged to continue watching it throughout the procedure.

Stress ball group: In addition to the standard clinical procedure, children in the stress ball group will be given a stress ball 1 minute before the procedure begins and will be encouraged to use it throughout the procedure.

Study summary

Aim: The aim of this study is to investigate the effect of using a stress ball and watching cartoons during the enema procedure-performed as part of the diagnosis and treatment process-on the levels of fear and pain in children aged 6-12 who present to the pediatric emergency department with gastrointestinal (GI) complaints. Method: The study will be conducted between September 2026 and May 2027 at the Pediatric Emergency Unit of Mersin University Faculty of Medicine Hospital with children who are scheduled to undergo enema treatment. Children scheduled to receive enema treatment (a total of 174 children) will be divided into three groups (cartoon-viewing group: 58; stress ball group: 58; control group: 58). All children's vital signs will be assessed prior to the enema procedure. An informational consent form will be administered to the children included in the study prior to the procedure, and fear and pain levels will be assessed by the nurse, parent, and child. In addition to the standard clinical procedure, children in the cartoon-watching group will be shown an age-appropriate cartoon 1 minute before the procedure begins. In addition to the standard clinical procedure, children in the stress ball group will be given a stress ball 1 minute before the procedure begins. No distraction techniques will be used for children in the control group.

Eligibility

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
Accepted
Inclusion Criteria: Children must: * Be undergoing their first enema procedure * Be 6-12 years * Speak Turkish * Have no communication difficulties * Both the child and the parent must be willing to participate in the study Exclusion Criteria: * The patient has a high fever (above 38.3) * The child has a visual, hearing, intellectual, or physical disability * The child has genetic-metabolic or chronic diseases * A parent has an intellectual disability * Administration of analgesics or sedatives prior to the procedure

Primary outcome measure(s)

  • Fear Scale — 1 day
    The scale was developed by Thurillet et al. (2022) 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 600 facial expressions. The scale rates fear on a scale ranging from 0 to 10 (graded in increments of two), consistent with pain rating scales. 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 = 0.878; p = 0.001)
  • Informative Questionnaire — 1 day
    The informative questionnaire, developed in accordance with the literature, consists of questions regarding the sociodemographic characteristics and health history of children and comprises a total of 20 questions (Padir, 2023; Düdükcü \& Padir, 2025). This form will be developed by researchers. Once permission has been obtained from the children and their parents who meet the inclusion criteria, this form will be completed by the nurse.
  • Pencil Pain Scale — 1 day
    The Pencil Pain Scale is a valid and reliable measurement tool developed to assess pain levels in children aged 6-12. The scale was developed by Güdücü Tüfekçi and Beyaz. On the scale, a 5-cm line on the pencil illustration is graded from "0" to "5." The "0" mark at the tip of the pencil indicates "no pain," while the "5" mark near the base indicates "unbearable pain." A higher score on the scale indicates an increase in the intensity of the pain the child is experiencing. The Pencil Pain Scale can be used both based on children's self-reports and by an observer (Güdücü Tüfekçi and Beyaz, 2018). The Pencil Pain Scale is a single-item, one-dimensional physical pain measurement tool shaped like a pencil, Because it is a single-item tool designed to measure a single point of pain intensity rather than a multi-question questionnaire,a traditional Cronbach's alpha internal consistency test is typically not applicable or reported for it

Trial sites (1)

FacilityCityRegionStatus
Tarsus University Mersin Turkey (Türkiye)
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07754136 on ClinicalTrials.gov ↗ ← All trials in Turkey