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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| The control group | No Intervention | The control group receives the routine preoperative preparation protocol of the Afyonkarahisar Health Sciences University MRI Center. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Parental Preoperative Anxiety and Information Requirement | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Afyonkarahisar Health Sciences University | Afyonkarahisar | 03030 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26969158 | Result | 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. |
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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.
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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Computer-generated random numbers
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| Preoperatively, in the waiting room, after the intervention but before the induction of sedation. |
| Parental Preoperative and Postoperative Anxiety Levels | 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. |