Anxiety in Children and Families During MRI Under Anesthesia

NCT07693309 | Completed

• 1 other identifier: AFSU-2026-MRI SEDATION
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled study evaluates the impact of age-appropriate therapeutic play and structured parental briefing on perioperative anxiety during pediatric MRI under sedation. Children aged 2-11 were assigned to either a multi-modal intervention group or a standard care control group. The primary objective was to measure child anxiety using the Modified Yale Preoperative Anxiety Scale (m-YALE) after the intervention. Secondary objectives included assessing parental anxiety via VAS/APAIS and measuring overall parental satisfaction in the recovery room. The study aims to demonstrate that a brief psychological intervention can effectively reduce stress for both children and their parents, even during prolonged hospital waiting times.

Conditions

Mental Health; Anxiety

Keywords

pediatric anesthesia; magnetic resonance imaging; preoperative anxiety; parental anxiety; child anxiety; sedation

Outcome Measures

Primary Outcomes (1)

• Children's Preoperative Anxiety Levels

  Assessed using the Modified Yale Preoperative Anxiety Scale. The total score ranges from a minimum value of 23.33 to a maximum value of 100. Higher scores indicate a worse outcome (greater severity of preoperative anxiety in the child).

  Preoperatively, in the waiting room, after the intervention but before the induction of sedation.

Secondary Outcomes (2)

• Parental Preoperative Anxiety and Information Requirement

  Preoperatively, in the waiting room, after the intervention but before the induction of sedation.

• Parental Preoperative and Postoperative Anxiety Levels

  Measured at two distinct time points: preoperatively in the waiting room (post-intervention but before the induction of sedation) and postoperatively in the recovery room.

Study Arms (2)

The intervention group

ACTIVE COMPARATOR

The intervention group receives a multi-modal psychological preparation protocol conducted by trained medical students prior to the MRI procedure.

Behavioral: Multi-modal Psychological Preparation

The control group

NO INTERVENTION

The control group receives the routine preoperative preparation protocol of the Afyonkarahisar Health Sciences University MRI Center.

Interventions

Multi-modal Psychological Preparation BEHAVIORAL

The intervention group receives a multi-modal psychological preparation protocol conducted by trained medical students prior to the MRI procedure. The intervention consists of two main components: Age-Appropriate Therapeutic Play: Children aged 2-7 (Pre-operational stage) receive symbolic medical play using toy kits and masks. Children aged 7-11 (Concrete operational stage) engage in interactive discussions and role-playing for 5-8 minutes. Structured Parental Briefing: Parents receive a standardized oral briefing covering the MRI working principles, duration of the scan, the role of the anesthesia team, and the recovery process. This is followed by a Q\&A session to address specific concerns.

The intervention group

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age Range
• Procedure Type
• Consent
• Caregiver Presence
• Physical Status

You may not qualify if:

• Cognitive dysfunction
• Emergency status
• Psychiatric disorders
• Medical contraindications
• Communication barriers

Sponsors & Collaborators

• Afyonkarahisar Health Sciences University: lead

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03030, Turkey (Türkiye)

Location

Related Publications (1)

• Li WHC, Chung JOK, Ho KY, Kwok BMC. Play interventions to reduce anxiety and negative emotions in hospitalized children. BMC Pediatr. 2016 Mar 11;16:36. doi: 10.1186/s12887-016-0570-5.

  PMID: 26969158 RESULT

MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Doctor

Model Details: Computer-generated random numbers

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 9, 2026
• Study Start: December 8, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)