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Pediatric Emergency CareNCT07754136

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

A study testing Cartoon watching group and Stress ball group in people with Pediatric Emergency Care, run by Tarsus University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
Conditions the study is for
Pediatric Emergency Care
What is being tested?
Cartoon watching group and Stress ball group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2026to 1 May 2027
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 6 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Duygu SÖNMEZ DÜZKAYA, PhD contact

++903246000033 ext. 2200

duygusduzkaya@tarsus.edu.tr

Fatma Nom contact

Turkey (Türkiye)1 site
  • Tarsus University

    Mersin, 33400

    Duygu SÖNMEZ DÜZKAYA, PhD, ++903246000033 ext. 2200, duygusduzkaya@tarsus.edu.tr

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Location and Time of the Study The study is planned to be conducted between September 2026 and May 2027 at the Pediatric Emergency Department of Mersin University Faculty of Medicine Hospital. The Pediatric Emergency Department consists of the following sections: Triage, Green Zone (6 beds), Yellow Zone (8 beds), Red/Critical Zone (3 beds), and Trauma Room (3 beds). The unit is staffed by 1 head nurse and 21 ward nurses. With an average of 220 patient visits per day, the most common reasons for presentation are fever, vomiting, diarrhea, abdominal pain, cough, respiratory distress, and trauma.

Research Variables Dependent variables: fear level, pain level Independent variables: use of a stress ball, showing cartoons

Data Collection The necessary ethics committee and institutional approvals will be obtained before the study begins. The study will be registered as a clinical trial. The study will include children aged 6-12 years who are undergoing enema procedures of the same type and volume at the Pediatric Emergency Department of Mersin University Faculty of Medicine Hospital and who meet the study's sample selection criteria. Children who do not meet the criteria will be excluded from the study. Procedures will be performed on children in all groups by the same nurse.

In line with the literature, researchers have identified distraction methods (cartoon content and the use of stress balls) appropriate for the developmental characteristics of children aged 6-12. To determine which cartoons will be used in the study, a pool of cartoons will be created by asking a total of ten children-five girls and five boys, aged 6-12-about their favorite cartoons. To evaluate the suitability of the cartoon pool, it will be presented to seven experts in the fields of child development, child psychiatry, and pediatric nursing to obtain their expert opinions. Children in Group 2 will use stress balls. The stress balls will be selected to be a size that children can easily grasp and of a soft texture. A pilot study involving 10 children will be conducted to evaluate the suitability of the data collection tools and distraction methods to be used in the study. The children included in the pilot study will not be included in the research sample. The children participating in the study and their parents will be informed about the purpose, content, and implementation process of the study. Written and verbal consent will be obtained from the parents, and verbal consent will be obtained from the children. All children participating in the study will receive routine clinical care.

Routine clinical procedure: Prior to the enema procedure, the child's vital signs are assessed, and the child is informed about the procedure using age-appropriate language.

The child is positioned appropriately (right or left lateral) and the parent is allowed to remain by the child's side during the procedure. During the procedure, the tip of the tube is lubricated and gently inserted into the rectal area, and the enema solution is administered. After the procedure, the child is monitored for potential complications. 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, the parent, and the child. Children who meet the sample selection criteria will be randomized into three groups using a computer-generated random number generator.

  1. Cartoon-viewing group: In addition to standard clinical practice, children in the cartoon-viewing group will be shown an age-appropriate cartoon 1 minute before the procedure begins and will be encouraged to continue watching throughout the procedure.
  2. Stress ball group: In addition to the standard clinical routine, 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.
  3. Control group: No distraction interventions will be applied to children in the control group; only standard clinical care will be provided.

The levels of fear and pain among children in all groups will be assessed immediately after the procedure is completed (before the child gets up from the dental chair). In addition, the satisfaction levels of children in the intervention groups will be assessed. The data collected will be analyzed using statistical methods, and the results will be reported.

Being tested
Cartoon watching group, Stress ball group
Keywords
pediatric, nurse, enema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cartoon watching groupOther

    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 groupOther

    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 groups in NCT07754136
Study groupRoleWhat they receive
Cartoon-Watching GroupExperimentalIn 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.
Receives: Other: Cartoon watching group
Stress ball groupExperimentalIn 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.
Receives: Other: Stress ball group
Control GroupNo interventionChildren in the control group will not be subjected to any distracting interventions; they will receive only routine clinical care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 day

  2. 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.

    Measured: 1 day

  3. 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

    Measured: 1 day

Secondary outcomes (1)
  1. Child Satisfaction Form

    The satisfaction assessment scale was developed based on the literature to ensure it is age-appropriate and easy for children to understand (Bozkul et al., 2024). On the scale, scores ranging from 0 to 10 are arranged along a horizontal line, and children are asked to mark the score that best reflects their satisfaction with the education provided. On the scale, a score of 0 indicates no satisfaction, while a score of 10 indicates the highest level of satisfaction. To facilitate the assessment, visuals representing different levels of satisfaction have been added to the points corresponding to the scores. ecause 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.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion10 Feb 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

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
174 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07754136
Sponsor's protocol ID
2026/08
Status last verified
Aug 2026
First submitted
3 Aug 2026
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 30498795
  • 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.

    PubMed 35300885
  • 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.

    PubMed 38663964
  • Hajehforoush, N. S., vd. (2024). Cartoons effect on pain and anxiety in children. Journal of Nursing and Midwifery Sciences, 11(1).

  • 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.

  • 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.

  • 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.

    PubMed 38101311

Questions about this trial

What is this clinical trial studying?

A study testing Cartoon watching group and Stress ball group in people with Pediatric Emergency Care, 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 5 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: opening soon, as of the sponsor's last update on 10 Aug 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 (++903246000033 ext. 2200, duygusduzkaya@tarsus.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fear Scale (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 NCT07754136, which also lists 7 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 10 Aug 2026.

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