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The Effect of a Riddle-Based Distraction Technique on Pain, Fear, and Anxiety During Cast Application in Children: A Randomized Study

22 september 2026 bijgewerkt door: Gamze Akay, Artvin Coruh University

The aim of this study is to determine the effect of a riddle-based distraction intervention, administered during cast application in children, on levels of pain, fear, and anxiety.

Studie Overzicht

Toestand

Werving

Interventie / Behandeling

Gedetailleerde beschrijving

Thirty-eight volunteer children aged 6-12 presenting to the Emergency Department Green Zone Cast Room at hospital for cast application (upper or lower extremity) will be randomly divided into two groups: intervention (riddle-based distraction) and control group. Children will be assessed before and during/after the procedure. Pain related to the cast application will be assessed with the Wong-Baker Faces Pain Scale, fear with the Child Fear Scale, and anxiety levels with the State-Trait Anxiety Inventory for Children (STAIC). In addition, children's sociodemographic and clinical data will be recorded in the Information Form.

Studietype

Ingrijpend

Inschrijving (Geschat)

68

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 jaar tot 12 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Being between 6 and 12 years of age
  • Scheduled for cast application (upper or lower extremity)
  • Conscious and able to communicate
  • Able to understand and speak Turkish
  • Having no auditory or cognitive impairments
  • Having no prior exposure to a similar non-pharmacological distraction intervention
  • Willingness of both the child and parent to participate in the study

Exclusion Criteria:

  • Being under the influence of analgesic, sedative, or anxiolytic medication
  • Having severe trauma or an unstable clinical condition requiring emergency intervention
  • Presence of developmental delay, neurological disease, or conditions affecting communication
  • Inability to participate in riddles due to hearing or visual impairment
  • Having prior cast experience on the same extremity
  • Inability to cooperate during the research process

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Control Group

Routine clinical care will be applied to the control group. No action will be taken.

Experimenteel: Experimental Group

Before and during the cast application, the child will be asked age-appropriate simple riddles, encouraged to actively participate through clues, and their attention will be distracted from the procedure.

Children who come to the hospital's cast room and meet the research criteria will be randomly assigned to the intervention group. The baseline scales and information forms will be filled out by the researcher through interviews with the child and parent before the cast application. Before the research, a pool of short, clear, and age-appropriate riddles will be prepared in consultation with experts, taking into account the cognitive levels of children aged 6-12. Prior to the procedure, brief communication will be established with the child to introduce the riddle game. During the cast preparation (preparing materials and positioning the extremity) and throughout the entire cast application process (wrapping, shaping, and setting the cast), the researcher will continuously ask the child riddles. The child's active participation will be encouraged by providing hints when needed and offering positive feedback. Active distraction turns the frightening cast room into an engaging space.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Identification Form
Tijdsspanne: Baseline

It is a form consisting of 4 questions in total, including the child's age, gender, previous fracture experience, and if any, how many times the child has experienced a fracture. It was prepared by the researcher in accordance with the literature.

Baseline
Wong-Baker FACES Pain Rating Scale
Tijdsspanne: Baseline and up to 4 weeks

This scale was developed by Donna Wong and Connie Moran Baker in 1981 to assess pain levels in children. Suitable for children aged 3-18 years, the scale consists of 6 facial expressions scored from '0' to '10'. A score of "0" indicates no pain, while a score of "10" represents the worst possible pain. In our study, the child will be shown the facial expressions on the scale, asked to choose the face that best describes their pain, and the corresponding score will be recorded.

Baseline and up to 4 weeks
Child Fear Scale - CFS
Tijdsspanne: Baseline and up to 4 weeks

Developed by McMurtry and colleagues, the Turkish validity of this scale was conducted by Gerçeker and colleagues. The changes in the facial muscles of a frightened expression were drawn by a graphic artist from a photograph of a frightened face. The scale features facial expressions scored from 0 to 4, where "0" indicates a neutral expression (no fear), "1" indicates a very low level of fear, "2" indicates a little fear, "3" indicates a greater level of fear, and "4" indicates the highest level of fear. In our study, the child will be shown the facial expressions on the fear scale, asked to select how they feel, and the corresponding score will be recorded.

Baseline and up to 4 weeks
State-Trait Anxiety Inventory for Children - STAIC / Thermometer
Tijdsspanne: Baseline and up to 4 weeks

Developed to measure anxiety in children, the Turkish validity of this tool was confirmed by Gerçeker and colleagues (Ayar et al.). The scale utilizes a thermometer visual with a bulb at the bottom representing a score of "0" and lines extending upwards divided into 10 sections reaching a score of "10". The child is explained that as their finger moves up from the bulb, their anxiety increases, whereas the bulb represents playing happily with friends. In our study, the child will be asked to point to the thermometer according to how they feel during the procedure, and the corresponding score will be recorded.

Baseline and up to 4 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Gamze AKAY, 1, Artvin Coruh University

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 november 2026

Primaire voltooiing (Geschat)

1 februari 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

22 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 september 2026

Eerst geplaatst (Werkelijk)

28 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 september 2026

Laatste update ingediend die voldeed aan QC-criteria

22 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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