- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Gamze AKAY, 1
- Telefonnummer: 05314536661
- E-Mail: gamzeakay_25@artvin.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Elif Simay KOÇ, 2
- Telefonnummer: +90 507 149 97 46
- E-Mail: elifsimay.koc@kilis.edu.tr
Studienorte
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Central
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Kilis, Central, Türkei (türkiye)
- Rekrutierung
- Kilis Prof. Dr. Alaeddin Yavaşca State Hospital, Kilis, Central
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Kontakt:
- Elif Simay KOÇ, 2
- Telefonnummer: +90 507 149 97 46
- E-Mail: elifsimay.koc@kilis.edu.tr
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Kein Eingriff: Control Group
Routine clinical care will be applied to the control group. No action will be taken. |
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Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Introductory Information Form
Zeitfenster: Baseline
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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
Zeitfenster: 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
Zeitfenster: 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).
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Gamze AKAY, 1, Artvin Coruh University
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Mandala Coloring in Children
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