- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07845123
The Effect of a Mandala Coloring-Based Nursing Intervention on Perceived Nursing Image and Anxiety in Children Hospitalized in a Pediatric Clinic: A Randomized Controlled Trial
The purpose of this study is to evaluate the effect of a mandala coloring-based nursing intervention on perceived nursing image and state anxiety levels in children aged 8-11 years hospitalized in a pediatric clinic.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The study will be conducted as a randomized controlled trial at the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital. A total of 64 children meeting the inclusion criteria will be randomly assigned to the intervention (n=32) and control (n=32) groups. Children in the intervention group will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days, while the control group will receive routine clinical care. Data will be collected using a Descriptive Information Form, the Children's Perceived Nursing Image Scale, and the State Anxiety Inventory for Children. State anxiety will be evaluated at baseline, on the third day, and before discharge, while perceived nursing image will be evaluated at baseline and before discharge.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Gamze AKAY, 1
- Numero di telefono: 05314536661
- Email: gamzeakay_25@artvin.edu.tr
Backup dei contatti dello studio
- Nome: Elif Simay KOÇ, 2
- Numero di telefono: +90 507 149 97 46
- Email: elifsimay.koc@kilis.edu.tr
Luoghi di studio
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Central
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Kilis, Central, Turchia (Türkiye)
- Reclutamento
- Kilis Prof. Dr. Alaeddin Yavaşca State Hospital, Kilis, Central
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Contatto:
- Elif Simay KOÇ, 2
- Numero di telefono: +90 507 149 97 46
- Email: elifsimay.koc@kilis.edu.tr
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Aged between 8 and 11 years
- Hospitalized in the Pediatric Clinic of Kilis Alaeddin Yavaşça State Hospital
- Expected hospitalization for at least three more days based on clinical evaluation and having no clinical impediment to completing the 3-day intervention protocol
- Able to read and write in Turkish with adequate cognitive ability to understand questions
- Willingness of both child and parent to participate, with written informed consent provided by the parent
- Being able to communicate at an adequate level
Exclusion Criteria:
- Inability to complete the 3-day intervention protocol due to early discharge or other reasons
- Deterioration of the child's clinical condition preventing continuation of the application
- Inability to complete data collection or outcome measurement procedures
- Request by the child or parent to withdraw from the study at any stage
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: Control Group
Routine clinical care will be applied to the control group. No action will be taken. |
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Sperimentale: Experimental Group
Children will receive a mandala coloring-based nursing intervention for 20 minutes once a day for three consecutive days during hospitalization, and their anxiety and perceived nursing image will be evaluated. |
Children in the intervention group will receive a mandala coloring-based nursing intervention conducted by the researcher for 20 minutes once daily over three consecutive days. The session will take place in the patient's room or a quiet area within the pediatric clinic at a time that does not interfere with routine care. Each child will be provided with an individual mandala coloring book and a set of 12 colored pencils. Prior to the session, brief communication will be established to explain the activity, allowing the child full autonomy over color selection and coloring style without interference. Communication from the researcher will remain neutral, standardized, and age-appropriate. Children in the control group will receive routine clinical care only, with no mandala coloring or other distraction interventions applied. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Introductory Information Form
Lasso di tempo: Baseline
|
The Introductory Information Form was prepared by the researchers based on the relevant literature. The form consists of a total of 10 questions designed to assess the sociodemographic characteristics of the children and their parents, as well as information regarding hospitalization. It includes questions concerning variables such as the child's age, gender, grade level, previous hospitalization experience, duration of stay, and reason for admission, as well as the parent's age, education level, employment status, and family type. |
Baseline
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State Anxiety Level
Lasso di tempo: Baseline (Day 1), Day 3 (1 hour after the final intervention session), and Pre-discharge (approximately 1 hour before discharge).
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Assessed using the State Anxiety Inventory for Children (SAIC / STAIC). The scale consists of 20 items scored between 20 and 60, where higher scores indicate higher levels of state anxiety. |
Baseline (Day 1), Day 3 (1 hour after the final intervention session), and Pre-discharge (approximately 1 hour before discharge).
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Perceived Nursing Image
Lasso di tempo: Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).
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Assessed using the Children's Perceived Nursing Image Scale. The scale consists of 35 items scored between 35 and 175, where higher scores indicate a more positive perception of the nursing image. |
Baseline (Day 1) and Pre-discharge (approximately 1 hour before discharge).
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gamze AKAY, 1, Artvin Coruh University
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Mandala Coloring in Children
Piano per i dati dei singoli partecipanti (IPD)
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