Visual Information Booklet and Anxiety in Preschool Children Undergoing Sedated MRI
The Effect of a Visual Information Booklet on Preprocedural Anxiety in Preschool Children Undergoing Magnetic Resonance Imaging Under Sedation: A Prospective Randomized Controlled Trial
This study examined whether an illustrated booklet could reduce anxiety in preschool children before magnetic resonance imaging (MRI) performed under sedation. Fifty children aged 3 to 6 years were randomly assigned to receive either the usual spoken explanation or the same explanation plus an illustrated booklet called "MR Maceram" ("My MRI Adventure"). Families received the booklet at the anesthesia outpatient clinic before the scan day.
On the MRI day, children's anxiety was assessed in the waiting area and again in the preparation area before intravenous cannulation and sedative medication. Parents completed an anxiety questionnaire, and children's cooperation during intravenous cannulation was recorded. The main comparison was children's anxiety in the preparation area. The study was conducted at Kocaeli University Faculty of Medicine Hospital in Türkiye and is being registered after completion.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Kocaeli
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İzmit, Kocaeli, Tyrkiet (Türkiye), 41380
- Kocaeli University Faculty of Medicine Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Children aged 3 to 6 years scheduled to undergo MRI under sedation.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent obtained from a parent.
Exclusion Criteria:
- Use of sedative or anxiolytic medication before the procedure.
- Emergency MRI.
- Acute pain, marked agitation, clinical instability, or communication or cooperation difficulties severe enough to prevent reliable assessment using the study scales.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: Standard Verbal Information
Children and their families received routine verbal information about the MRI and sedation process at the anesthesia outpatient clinic. They did not receive the illustrated booklet. |
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Eksperimentel: MR Maceram Booklet and Standard Verbal Information
Children and their families received routine verbal information plus the illustrated "MR Maceram" booklet at the anesthesia outpatient clinic before the MRI day. Families could review the booklet with their child before the scan. |
An age-appropriate illustrated booklet explaining hospital arrival, waiting, intravenous cannulation, sedation, the MRI scan, and recovery. It was given at the anesthesia outpatient clinic before the MRI day in addition to routine verbal information. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Child Anxiety Before IV Cannulation (mYPAS-T2)
Tidsramme: Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).
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Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Child Anxiety in the MRI Waiting Area (mYPAS-T1)
Tidsramme: Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).
|
Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).
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Parental State Anxiety (STAI-S)
Tidsramme: Periprocedural (MRI day), while the child was in the MRI waiting area (T1).
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Parental state anxiety was assessed using the State-Trait Anxiety Inventory, State subscale (STAI-S). Scores range from 20 to 80, with higher scores indicating greater anxiety. |
Periprocedural (MRI day), while the child was in the MRI waiting area (T1).
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Child Cooperation During IV Cannulation
Tidsramme: Periprocedural (MRI day), during IV cannulation before sedative administration.
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Cooperation was assessed using a three-category observational scale: 0, good cooperation; 1, partial resistance; and 2, marked resistance. |
Periprocedural (MRI day), during IV cannulation before sedative administration.
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Murat Tekin, MD, Kocaeli University Faculty of Medicine, Department of Anesthesiology and Reanimation
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GOKAEK-2026/07/38
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Individual participant data will not be shared with other researchers. The informed consent specified that study data would be accessible only to the research team.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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