Visual Information Booklet and Anxiety in Preschool Children Undergoing Sedated MRI

NCT07861711 | Completed

• 1 other identifier: GOKAEK-2026/07/38
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety

Keywords

Pediatric MRI; Procedural anxiety; Illustrated booklet; Sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Child Anxiety in the MRI Waiting Area (mYPAS-T1)

  Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).

• Parental State Anxiety (STAI-S)

  Periprocedural (MRI day), while the child was in the MRI waiting area (T1).

• Child Cooperation During IV Cannulation

  Periprocedural (MRI day), during IV cannulation before sedative administration.

Study Arms (2)

Standard Verbal Information

NO INTERVENTION

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.

MR Maceram Booklet and Standard Verbal Information

EXPERIMENTAL

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

Interventions

MR Maceram Illustrated Information Booklet BEHAVIORAL

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.

MR Maceram Booklet and Standard Verbal Information

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University Faculty of Medicine Hospital

İzmit, Kocaeli, 41380, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Murat Tekin, MD

  Kocaeli University Faculty of Medicine, Department of Anesthesiology and Reanimation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist who assessed the children's anxiety (mYPAS) and IV cannulation cooperation also provided anesthesia care. This person did not participate in randomization or booklet delivery, had no access to the randomization list, and was not informed of group assignments. Participants and parents could not be blinded due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Anesthesiologist

Model Details: Two-arm, parallel-group, randomized controlled trial. Children aged 3-6 years undergoing MRI under sedation were assigned to either standard verbal information plus the "MR Maceram" illustrated booklet or standard verbal information alone (25 children per group). Assignment was performed using computer-based randomization.

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 6, 2026
• Study Start: April 24, 2026
• Primary Completion: June 25, 2026
• Study Completion: June 25, 2026
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)