Anxiety in Children and Families During MRI Under Anesthesia

July 7, 2026 updated by: Kamil Taşkapılı, Afyonkarahisar Health Sciences University

The Relationship Between Anxiety Levels of Families and Children Undergoing Magnetic Resonance Imaging Under Anesthesia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 control group receives the routine preoperative preparation protocol of the Afyonkarahisar Health Sciences University MRI Center. This standard care includes a pre-anesthetic clinical assessment by the anesthesiology team, verification of fasting status (nil per os), and standard institutional monitoring procedures. Unlike the intervention group, participants in the control group do not receive age-appropriate therapeutic play or a structured, standardized parental briefing session prior to sedation. Interaction with medical staff remains limited to routine clinical and administrative procedures.

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Afyonkarahisar, Turkey (Türkiye), 03030
        • Afyonkarahisar Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: The intervention group
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 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.
No Intervention: The control group
The control group receives the routine preoperative preparation protocol of the Afyonkarahisar Health Sciences University MRI Center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's Preoperative Anxiety Levels
Time Frame: Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parental Preoperative Anxiety and Information Requirement
Time Frame: Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
Assessed using the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The APAIS is a 6-item instrument consisting of two distinct subscales: a 4-item anxiety subscale and a 2-item information requirement subscale. Each item is rated on a 5-point Likert scale (1 to 5). For the anxiety subscale, the scores range from a minimum value of 4 to a maximum value of 20. For the information requirement subscale, the scores range from a minimum value of 2 to a maximum value of 10. Higher scores on both subscales indicate a worse outcome (higher levels of parental anxiety and a greater need for information, respectively).
Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
Parental Preoperative and Postoperative Anxiety Levels
Time Frame: 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.
Assessed using the Visual Analogue Scale (VAS) for anxiety. The scale consists of a horizontal line where parents self-report their current anxiety intensity. The scores range from a minimum value of 0 (representing 'no anxiety') to a maximum value of 10 (representing 'the worst possible anxiety'). Higher scores indicate a worse outcome (greater severity of parental anxiety).
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Afyonkarahisar Health Sciences University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2025

Primary Completion (Actual)

March 31, 2026

Study Completion (Actual)

March 31, 2026

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

July 7, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AFSU-2026-MRI SEDATION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be shared publicly to protect patient confidentiality and maintain strict data privacy, in compliance with the national data protection laws (KVKK) and institutional review board regulations. The informed consent form signed by the parents/legal guardians specifically states that the collected clinical and psychological data will only be used for the purposes of this specific research project and will not be disclosed to third parties or uploaded to public repositories. However, the aggregated study results, statistical summaries, and methodology will be fully disseminated through peer-reviewed publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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