Mental HealthNCT07693309
Anxiety in Children and Families During MRI Under Anesthesia
A study testing Multi-modal Psychological Preparation in people with Mental Health and Anxiety, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Mental Health, Anxiety
- What is being tested?
- Multi-modal Psychological Preparation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Dec 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age Range
- Procedure Type
- Consent
- Caregiver Presence
- Physical Status
Who cannot join
- Cognitive dysfunction
- Emergency status
- Psychiatric disorders
- Medical contraindications
- Communication barriers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University
Afyonkarahisar, 03030
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health, Anxiety
- Being tested
- Multi-modal Psychological Preparation
- Keywords
- pediatric anesthesia, magnetic resonance imaging, preoperative anxiety, parental anxiety, child anxiety, sedation
- Medical subject headings
- Psychological Well-Being, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal Psychological PreparationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Preoperatively, in the waiting room, after the intervention but before the induction of sedation.
Secondary outcomes (2)
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).
Measured: 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: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start8 Dec 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Computer-generated random numbers
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamil Taşkapılı, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693309
- Sponsor's protocol ID
- AFSU-2026-MRI SEDATION
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26969158
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Anxiety Levels of Families and Children Undergoing Magnetic Resonance Imaging Under Anesthesia
- ClinicalTrials.gov ID
- NCT07693309
- Acronym / sponsor ID
- AFSU-2026-MRI SEDATION
- Conditions
- Mental Health, Anxiety
- Keywords
- pediatric anesthesia, magnetic resonance imaging, preoperative anxiety, parental anxiety, child anxiety, sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Computer-generated random numbers
| Arm | Type | Receives |
|---|---|---|
| The intervention group | Active comparator | Behavioral: Multi-modal Psychological PreparationThe intervention group receives a multi-modal psychological preparation protocol conducted by trained medical students prior to the MRI procedure. |
| The control group | No intervention | –The control group receives the routine preoperative preparation protocol of the Afyonkarahisar Health Sciences University MRI Center. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age Range
- Procedure Type
- Consent
- Caregiver Presence
- Physical Status
Key exclusion criteria (5 listed)
- Cognitive dysfunction
- Emergency status
- Psychiatric disorders
- Medical contraindications
- Communication barriers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal Psychological PreparationThe 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. | Behavioural | The intervention group |
Primary outcome
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).
2 secondary outcomes
Parental Preoperative Anxiety and Information Requirement
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Results publication: PubMed 26969158Li 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal Psychological Preparation in people with Mental Health and Anxiety, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Preoperative Anxiety Levels (time frame: Preoperatively, in the waiting room, after the intervention but before the induction of sedation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07693309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.