AnxietyNCT07861711
Visual Information Booklet and Anxiety in Preschool Children Undergoing Sedated MRI
A study testing MR Maceram Illustrated Information Booklet in people with Anxiety, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
This study examined whether an illustrated booklet could reduce anxiety in preschool children before magnetic resonance imaging (MRI) performed under sedation. Fifty children aged 3 to 6 years were randomly assigned to receive either the usual spoken explanation or the same explanation plus an illustrated booklet… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Anxiety
- What is being tested?
- MR Maceram Illustrated Information Booklet
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2026to 25 Jun 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 6 years scheduled to undergo MRI under sedation.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent obtained from a parent.
Who cannot join
- Use of sedative or anxiolytic medication before the procedure.
- Emergency MRI.
- Acute pain, marked agitation, clinical instability, or communication or cooperation difficulties severe enough to prevent reliable assessment using the study scales.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Faculty of Medicine Hospital
İzmit, Kocaeli, 41380
About this study
Official title: The Effect of a Visual Information Booklet on Preprocedural Anxiety in Preschool Children Undergoing Magnetic Resonance Imaging Under Sedation: A Prospective Randomized Controlled Trial
This study examined whether an illustrated booklet could reduce anxiety in preschool children before magnetic resonance imaging (MRI) performed under sedation. Fifty children aged 3 to 6 years were randomly assigned to receive either the usual spoken explanation or the same explanation plus an illustrated booklet called "MR Maceram" ("My MRI Adventure"). Families received the booklet at the anesthesia outpatient clinic before the scan day.
On the MRI day, children's anxiety was assessed in the waiting area and again in the preparation area before intravenous cannulation and sedative medication. Parents completed an anxiety questionnaire, and children's cooperation during intravenous cannulation was recorded. The main comparison was children's anxiety in the preparation area. The study was conducted at Kocaeli University Faculty of Medicine Hospital in Türkiye and is being registered after completion.
- Conditions
- Anxiety
- Being tested
- MR Maceram Illustrated Information Booklet
- Keywords
- Pediatric MRI, Procedural anxiety, Illustrated booklet, Sedation
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR Maceram Illustrated Information BookletBehavioural
An age-appropriate illustrated booklet explaining hospital arrival, waiting, intravenous cannulation, sedation, the MRI scan, and recovery. It was given at the anesthesia outpatient clinic before the MRI day in addition to routine verbal information.
| Study group | Role | What they receive |
|---|---|---|
| Standard Verbal Information | No intervention | Children and their families received routine verbal information about the MRI and sedation process at the anesthesia outpatient clinic. They did not receive the illustrated booklet. |
| MR Maceram Booklet and Standard Verbal Information | Experimental | Children and their families received routine verbal information plus the illustrated "MR Maceram" booklet at the anesthesia outpatient clinic before the MRI day. Families could review the booklet with their child before the scan. Receives: Behavioral: MR Maceram Illustrated Information Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Anxiety Before IV Cannulation (mYPAS-T2)
Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety.
Measured: Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).
Secondary outcomes (3)
Child Anxiety in the MRI Waiting Area (mYPAS-T1)
Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety.
Measured: Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).
Parental State Anxiety (STAI-S)
Parental state anxiety was assessed using the State-Trait Anxiety Inventory, State subscale (STAI-S). Scores range from 20 to 80, with higher scores indicating greater anxiety.
Measured: Periprocedural (MRI day), while the child was in the MRI waiting area (T1).
Child Cooperation During IV Cannulation
Cooperation was assessed using a three-category observational scale: 0, good cooperation; 1, partial resistance; and 2, marked resistance.
Measured: Periprocedural (MRI day), during IV cannulation before sedative administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start24 Apr 2026
- Primary completion25 Jun 2026
- Study completion25 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group, randomized controlled trial. Children aged 3-6 years undergoing MRI under sedation were assigned to either standard verbal information plus the "MR Maceram" illustrated booklet or standard verbal information alone (25 children per group). Assignment was performed using computer-based randomization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tunay Ulutaş, Kocaeli University
- Investigators
- Murat Tekin, MD, Study director, Kocaeli University Faculty of Medicine, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861711
- Sponsor's protocol ID
- GOKAEK-2026/07/38
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. The informed consent specified that study data would be accessible only to the research team.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Visual Information Booklet on Preprocedural Anxiety in Preschool Children Undergoing Magnetic Resonance Imaging Under Sedation: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07861711
- Acronym / sponsor ID
- GOKAEK-2026/07/38
- Conditions
- Anxiety
- Keywords
- Pediatric MRI, Procedural anxiety, Illustrated booklet, Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 25 Jun 2026 (actual)
- Study completion
- 25 Jun 2026 (actual)
- First posted
- 6 Oct 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 study examined whether an illustrated booklet could reduce anxiety in preschool children before magnetic resonance imaging (MRI) performed under sedation. Fifty children aged 3 to 6 years were randomly assigned to receive either the usual spoken explanation or the same explanation plus an illustrated booklet called "MR Maceram" ("My MRI Adventure"). Families received the booklet at the anesthesia outpatient clinic before the scan day.
On the MRI day, children's anxiety was assessed in the waiting area and again in the preparation area before intravenous cannulation and sedative medication. Parents completed an anxiety questionnaire, and children's cooperation during intravenous cannulation was recorded. The main comparison was children's anxiety in the preparation area. The study was conducted at Kocaeli University Faculty of Medicine Hospital in Türkiye and is being registered after completion.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group, randomized controlled trial. Children aged 3-6 years undergoing MRI under sedation were assigned to either standard verbal information plus the "MR Maceram" illustrated booklet or standard verbal information alone (25 children per group). Assignment was performed using computer-based randomization.
| Arm | Type | Receives |
|---|---|---|
| Standard Verbal Information | No intervention | –Children and their families received routine verbal information about the MRI and sedation process at the anesthesia outpatient clinic. They did not receive the illustrated booklet. |
| MR Maceram Booklet and Standard Verbal Information | Experimental | Behavioral: MR Maceram Illustrated Information BookletChildren and their families received routine verbal information plus the illustrated "MR Maceram" booklet at the anesthesia outpatient clinic before the MRI day. Families could review the booklet with their child before the scan. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 3 to 6 years scheduled to undergo MRI under sedation.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Written informed consent obtained from a parent.
Key exclusion criteria (3 listed)
- Use of sedative or anxiolytic medication before the procedure.
- Emergency MRI.
- Acute pain, marked agitation, clinical instability, or communication or cooperation difficulties severe enough to prevent reliable assessment using the study scales.
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 |
|---|---|---|
| MR Maceram Illustrated Information BookletAn age-appropriate illustrated booklet explaining hospital arrival, waiting, intravenous cannulation, sedation, the MRI scan, and recovery. It was given at the anesthesia outpatient clinic before the MRI day in addition to routine verbal information. | Behavioural | MR Maceram Booklet and Standard Verbal Information |
Primary outcome
Child Anxiety Before IV Cannulation (mYPAS-T2)
Time frame: Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).
Child anxiety was assessed using the modified Yale Preoperative Anxiety Scale (mYPAS). Scores range from 23.33 to 100, with higher scores indicating greater anxiety.
3 secondary outcomes
Child Anxiety in the MRI Waiting Area (mYPAS-T1)
Time frame: Periprocedural (MRI day), in the MRI waiting area before transfer to the preparation area (T1).
Parental State Anxiety (STAI-S)
Time frame: Periprocedural (MRI day), while the child was in the MRI waiting area (T1).
Child Cooperation During IV Cannulation
Time frame: Periprocedural (MRI day), during IV cannulation before sedative administration.
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 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. The informed consent specified that study data would be accessible only to the research team.
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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.
Murat Tekin, MD study director
Kocaeli University Faculty of Medicine, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR Maceram Illustrated Information Booklet in people with Anxiety, run by Kocaeli 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 3 inclusion and 3 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 15 Oct 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?
Child Anxiety Before IV Cannulation (mYPAS-T2) (time frame: Periprocedural (MRI day), in the MRI preparation area immediately before IV cannulation and sedative administration (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2026.