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.

Study Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: MR Maceram Illustrated Information Booklet

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Kocaeli
    • İzmit, Kocaeli, Turkey (Türkiye), 41380
      • Kocaeli University Faculty of Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: MR Maceram Illustrated Information Booklet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Anxiety Before IV Cannulation (mYPAS-T2)	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Anxiety in the MRI Waiting Area (mYPAS-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).
Parental State Anxiety (STAI-S)	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).
Child Cooperation During IV Cannulation	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.

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Study Director: Murat Tekin, MD, Kocaeli University Faculty of Medicine, Department of Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2026
• Primary Completion (Actual): June 25, 2026
• Study Completion (Actual): June 25, 2026

Study Registration Dates

• First Submitted: October 1, 2026
• First Submitted That Met QC Criteria: October 1, 2026
• First Posted (Actual): October 6, 2026

Study Record Updates

• Last Update Posted (Actual): October 15, 2026
• Last Update Submitted That Met QC Criteria: October 9, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Sedation; Procedural anxiety; Pediatric MRI; Illustrated booklet
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: GOKAEK-2026/07/38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No