NCT07746973

Brief Summary

Children frequently experience pain and fear during invasive procedures such as venipuncture and peripheral intravenous catheter insertion. These experiences may negatively affect children's cooperation during procedures and increase anxiety related to future healthcare encounters. Non-pharmacological distraction techniques are recommended to reduce procedure-related pain and fear in pediatric patients. This randomized controlled trial aims to evaluate the effect of a standardized magic show featuring "Kuco" on pain and fear experienced by children during invasive procedures. Eighty children aged 5-8 years who require venipuncture or peripheral intravenous catheter insertion will be randomly assigned to either an intervention group or a control group. Children in the intervention group will receive a standardized magic show performed with the "Kuco" puppet before and throughout the invasive procedure, whereas children in the control group will receive routine clinical care only. Pain and fear will be assessed immediately before and after the procedure using the Wong-Baker FACES Pain Rating Scale and the Children's Fear Scale. The findings are expected to provide evidence regarding the effectiveness of a magic show-based distraction intervention for reducing procedure-related pain and fear in children.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress18%
Jun 2026Dec 2027

Study Start

First participant enrolled

June 29, 2026

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 5, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 27, 2026

Last Update Submit

July 30, 2026

Conditions

Keywords

PediatricChildrenMagic ShowDistractionNonpharmacological InterventionPainFearVenipuncturePeripheral Intravenous CatheterizationWong-Baker FACES Pain Rating ScaleChildren's Fear ScalePuppetKuco

Outcome Measures

Primary Outcomes (2)

  • Procedure-Related Pain

    Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale immediately before and within 1 minute after the invasive procedure. The scale ranges from 0 to 10, with higher scores indicating greater pain intensity.

    Immediately before and within 1 minute after the invasive procedure.

  • Procedure-Related Fear

    Fear will be assessed using the Children's Fear Scale immediately before and within 1 minute after the invasive procedure. The scale ranges from 0 to 4, with higher scores indicating greater fear.

    Immediately before and within 1 minute after the invasive procedure.

Study Arms (2)

Magic Show Intervention

EXPERIMENTAL

Participants in this arm will receive a standardized magic show featuring the "Kuco" puppet before and throughout the invasive procedure (venipuncture or peripheral intravenous catheter insertion), in addition to routine clinical care. The intervention is designed as a non-pharmacological distraction technique to reduce procedure-related pain and fear.

Behavioral: Kuco Magic Show

Control

NO INTERVENTION

Participants in this arm will receive routine clinical care during venipuncture or peripheral intravenous catheter insertion without any additional distraction intervention.

Interventions

Kuco Magic ShowBEHAVIORAL

Participants assigned to the intervention group will receive a standardized magic show featuring the "Kuco" puppet as a behavioral distraction technique before and throughout the invasive procedure (venipuncture or peripheral intravenous catheter insertion). The intervention will be delivered by a trained researcher using a standardized protocol that includes interactive magic tricks and verbal engagement to maintain the child's attention during the procedure. The magic show will begin approximately 2 minutes before the procedure and continue until the procedure is completed, in addition to routine clinical care.

Also known as: Kuco Distraction Intervention
Magic Show Intervention

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5 to 8 years.
  • Requiring venipuncture or peripheral intravenous catheter insertion in the pediatric emergency department, pediatric blood collection unit, or pediatric day-care unit.
  • Able to communicate in Turkish.
  • Conscious and able to respond to the study scales.
  • No visual or hearing impairment that would interfere with participation in the intervention or outcome assessment.
  • Parent or legal guardian provides written informed consent, and the child provides assent when appropriate.

You may not qualify if:

  • Presence of a chronic psychiatric or neurological disorder.
  • Presence of a severe chronic medical condition that may affect pain or fear perception.
  • Administration of analgesic, sedative, or anxiolytic medication before the procedure.
  • Previous participation in this study.
  • Child or parent refuses to participate or withdraws consent at any stage of the study.
  • Failure to complete the invasive procedure or the study assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bingöl State Hospital

Bingoel, Bingöl, 12000, Turkey (Türkiye)

Location

Related Publications (13)

  • Zimmerman, F. J., & Bell, J. F. (2010). Associations of television content type and amount with obesity: A longitudinal study. International Journal of Behavioral Nutrition and Physical Activity, 7(1), 54. https://doi.org/10.1186/1479-5868-7-54

    BACKGROUND
  • Yılmaz, R., Erkorkmaz, Ü., & Yıldız, H. (2011). Çocuklarda yeme davranışı anketinin Türkçe geçerlik ve güvenirlik çalışması. Anadolu Psikiyatri Dergisi, 12(4), 287-294.

    BACKGROUND
  • Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792.

    PMID: 11693591BACKGROUND
  • Rideout, V., & Robb, M. B. (2020). The Common Sense census: Media use by kids age zero to eight. Common Sense Media. https://www.commonsensemedia.org/sites/default/files/research/report/2020_zero_to_eight_census_final_web.pdf

    BACKGROUND
  • Öztürk, M., & Akçay, D. (2024). Okul öncesi dönem çocuklarında ekran maruziyeti ve beslenme alışkanlıkları üzerine bir inceleme. Sağlık Bilimleri ve Meslekleri Dergisi, 11(1), 45-58.

    BACKGROUND
  • McArthur, B. A., Browne, D., McDonald, S., Tough, S., & Madigan, S. (2022). Longitudinal associations between screen time and children's developmental milestones. JAMA Pediatrics, 176(1), 52-60. https://doi.org/10.1001/jamapediatrics.2021.4686

    BACKGROUND
  • Harris JL, Bargh JA, Brownell KD. Priming effects of television food advertising on eating behavior. Health Psychol. 2009 Jul;28(4):404-13. doi: 10.1037/a0014399.

    PMID: 19594263BACKGROUND
  • Furuncu, M., & Öztürk, E. (2020). Okul öncesi çocuklarda problemli medya kullanımının değerlendirilmesi: Geçerlik ve güvenirlik çalışması. Çocuk ve Gençlik Ruh Sağlığı Dergisi, 27(3), 173-183.

    BACKGROUND
  • Furuncu, M. (2020). Okul öncesi dönem çocuklarda problemli medya kullanımının ebeveyn tutumları ve çocuk özellikleri açısından incelenmesi. Yayımlanmamış yüksek lisans tezi, İstanbul Üniversitesi-Cerrahpaşa.

    BACKGROUND
  • Domoff, S. E., Radesky, J. S., Harrison, K., Riley, H., Lumeng, J. C., Miller, A. L., & Gearhardt, A. N. (2020). A prospective study of television in the home, television in the bedroom, and overweight/obesity from infancy to middle childhood. Pediatric Obesity, 15(4), e12601. https://doi.org/10.1111/ijpo.12601

    BACKGROUND
  • Domoff SE, Harrison K, Gearhardt AN, Gentile DA, Lumeng JC, Miller AL. Development and Validation of the Problematic Media Use Measure: A Parent Report Measure of Screen Media "Addiction" in Children. Psychol Pop Media Cult. 2019 Jan;8(1):2-11. doi: 10.1037/ppm0000163. Epub 2017 Nov 16.

    PMID: 30873299BACKGROUND
  • Boyland EJ, Whalen R. Food advertising to children and its effects on diet: review of recent prevalence and impact data. Pediatr Diabetes. 2015 Aug;16(5):331-7. doi: 10.1111/pedi.12278. Epub 2015 Apr 21.

    PMID: 25899654BACKGROUND
  • Aman, M. G., Arnold, L. E., & Hollway, J. A. (2022). Digital media and eating behaviors in early childhood: A systematic review. Appetite, 168, 105884. https://doi.org/10.1016/j.appet.2021.105884

    BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Abdullah Sarman, Associate Professor

    Bingöl University, Faculty of Health Sciences, Department of Pediatric Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 5, 2026

Study Start

June 29, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Last Updated

August 5, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to participant confidentiality and data protection considerations. Only aggregated study results will be disseminated.

Locations