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Completed

NCT Number: NCT07693309

Anxiety in Children and Families During MRI 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.

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Key information

Conditions

Mental Health Anxiety Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

2 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Afyonkarahisar Health Sciences University

Afyonkarahisar, 03030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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