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

NCT07754136 | Not Yet Recruiting

• 1 other identifier: 2026/08
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Emergency Care

Keywords

pediatric; nurse; enema

Outcome Measures

Primary Outcomes (3)

• Fear Scale

  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)

  1 day

• Informative Questionnaire

  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.

  1 day

• Pencil Pain Scale

  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

  1 day

Secondary Outcomes (1)

• Child Satisfaction Form

  1 day

Study Arms (3)

Cartoon-Watching Group

EXPERIMENTAL

In addition to the standard clinical procedures, children in the cartoon-viewing 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.

Other: Cartoon watching group

Stress ball group

EXPERIMENTAL

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.

Other: Stress ball group

Control Group

NO INTERVENTION

Children in the control group will not be subjected to any distracting interventions; they will receive only routine clinical care.

Interventions

Cartoon watching group OTHER

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.

Cartoon-Watching Group

Stress ball group OTHER

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.

Stress ball group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Tarsus University

Mersin, 33400, Turkey (Türkiye)

Location

Related Publications (7)

• Timmerman MEW, Trzpis M, Broens PMA. Using laxatives and/or enemas to accelerate the diagnosis in children presenting with acute abdominal pain: a randomised controlled trial study protocol. BMJ Paediatr Open. 2018 Nov 9;2(1):e000341. doi: 10.1136/bmjpo-2018-000341. eCollection 2018.

  PMID: 30498795 BACKGROUND

• 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.

  PMID: 35300885 BACKGROUND

• Tavsan B, Uysal G, Semerci R. Psychometric Property Examination of a Self-Assessment Fear Scale in Turkish Children Aged 4-12 Years: A Methodological Study. Res Theory Nurs Pract. 2024 Apr 25;38(2):211-226. doi: 10.1891/RTNP-2023-0102.

  PMID: 38663964 BACKGROUND

• Hajehforoush, N. S., vd. (2024). Cartoons effect on pain and anxiety in children. Journal of Nursing and Midwifery Sciences, 11(1).

  BACKGROUND

• Gündüz, S., Yüksel, S., Aydeniz, G. E., Aydoğan, R. N., Türksoy, H., Dikme, İ. B., & Efendiler, İ. (2016). Çocuklarda hastane korkusunu etkileyen faktörler. Çocuk Sağlığı ve Hastalıkları Dergisi, 59(4), 161-168.

  BACKGROUND

• Düdükcü, F. T., & Padir, Z. (2025). Çocuklarda lavman öncesi ve sonrası korku, ağrı ve kaygı: Tanımlayıcı kesitsel çalışma [Yayımlanmamış çalışma]. Pamukkale Üniversitesi Sağlık Bilimleri Enstitüsü.

  BACKGROUND

• Bozkul G, Karakul A, Duzkaya DS, Dilsen S. Effect of short film video and video-based education on fear, pain, and satisfaction of children undergoing day surgery. J Pediatr Nurs. 2024 Mar-Apr;75:49-56. doi: 10.1016/j.pedn.2023.11.029. Epub 2023 Dec 14.

  PMID: 38101311 BACKGROUND

Central Study Contacts

Duygu SÖNMEZ DÜZKAYA, PhD

CONTACT

++903246000033; duygusduzkaya@tarsus.edu.tr

Fatma Nom

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 10, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Locations

TU (1)