Anxiety in Children and Families During MRI Under Anesthesia

NCT07693309 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-07-09

No results posted yet for this study

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

Interventions

BEHAVIORAL

Multi-modal Psychological Preparation

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.

Sponsors & Collaborators

  • Afyonkarahisar Health Sciences University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-03-31
Completion
2026-03-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07693309 on ClinicalTrials.gov