- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07845136
The Effect of a Riddle-Based Distraction Technique on Pain, Fear, and Anxiety During Cast Application in Children: A Randomized Study
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Gamze AKAY, 1
- Telefonnummer: 05314536661
- E-post: gamzeakay_25@artvin.edu.tr
Studera Kontakt Backup
- Namn: Elif Simay KOÇ, 2
- Telefonnummer: 903488142666
- E-post: elifsimay.koc@kilis.edu.tr
Studieorter
-
-
Central
-
Kilis, Central, Turkiet (Türkiye)
- Rekrytering
- Kilis Prof. Dr. Alaeddin Yavaşca State Hospital
-
Kontakt:
- Elif Simay KOÇ, 2
- Telefonnummer: +903488142666
- E-post: elifsimay.koc@kilis.edu.tr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Control Group
Routine clinical care will be applied to the control group. No action will be taken. |
|
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Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient Identification Form
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gamze AKAY, 1, Artvin Coruh University
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Riddle-Based in Children
Plan för individuella deltagardata (IPD)
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