AnxietyNCT07203716
Preparing Kids for MRI Using VR
A study testing Virtual Reality Orientation (Home+Booster) and Virtual Reality Orientation (Pre-Scan Only) in people with Anxiety and Sedation, run by Haseki Training and Research Hospital.
Trial summary
Children frequently exhibit pre-MRI anxiety that can cause motion, repeated sequences, prolonged room time, and exposure to sedation. Orientation with Virtual Reality (VR) may reduce anxiety by familiarizing children with the scanner environment and expected sensations. Read more about this study
- Who is it for?
- Ages 5 to 10 years
- What is being tested?
- Virtual Reality Orientation (Home+Booster) and Virtual Reality Orientation (Pre-Scan Only)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 5 to 10 years old (inclusive).
- First-ever MRI for a clinically indicated, non-emergent examination (outpatient or elective inpatient).
- Ability to view the age-appropriate 360° VR module (head-mounted viewer or flat 360° on screen) with basic comprehension of instructions (child and/or caregiver in Turkish).
- Parental/guardian informed consent and child assent per age/competence.
- Standard MRI safety screening passed; institutional rescue sedation policies remain available if clinically required.
Who cannot join
- MRI contraindications (e.g., non-MR-conditional implants, unsafe metallic foreign bodies).
- Pre-planned sedation or general anesthesia irrespective of behavior (clinician decision made prior to randomization).
- Conditions contraindicating VR exposure (e.g., uncontrolled epilepsy, severe motion sickness/vertigo causing intolerance).
- Severe uncorrected visual or hearing impairment precluding module viewing or instruction adherence.
- Emergent/urgent MRI where study procedures could delay care.
- Neurodevelopmental or behavioral conditions that render still positioning entirely unfeasible despite standard coaching (investigator judgment).
- Prior participation in this trial (no re-enrollment).
About this study
Official title: Effect of Home-Based and Immediate Pre-Scan Virtual Reality Orientation on Motion Artifacts and Sedation Need in Pediatric MRI: A Three-Arm Randomized Controlled Trial
Children frequently exhibit pre-MRI anxiety that can cause motion, repeated sequences, prolonged room time, and exposure to sedation. Orientation with Virtual Reality (VR) may reduce anxiety by familiarizing children with the scanner environment and expected sensations. This single-center, three-arm randomized clinical trial evaluates whether (1) Home+Booster VR (an age-appropriate 360° VR module at home ~24-48 hours before MRI plus a brief on-site refresher immediately before positioning), (2) Pre-Scan VR only (same module viewed on site immediately before positioning), or (3) Usual Care without VR improves MRI image quality and tolerance in children undergoing their first-ever MRI.
Eligible participants are children scheduled for clinically indicated, non-emergent MRI with no prior MRI experience. Major exclusions comprise MRI contraindications; contraindications to VR use (e.g., uncontrolled epilepsy or severe motion sickness); uncorrected severe visual/hearing impairment precluding VR viewing; and inability to provide assent/consent. After consent/assent, participants are randomized 1:1:1 to one of three arms. Anticipated enrollment is ~150 total (~50 per arm; up to 60 per arm if feasible). All arms receive routine safety procedures and child-oriented coaching per institutional practice. The VR module (~8-10 minutes) provides a 360° walkthrough of the MRI process (sounds, positioning, keeping still) with child-focused narration. Adherence (timestamps/duration) is recorded where applicable.
The primary outcome is motion artifact rated on a predefined ordinal scale by a board-certified radiologist masked to allocation; the proportion achieving diagnostic quality without repeat/sedation is also reported. Key secondary outcomes include sedation requirement, number of repeated sequences, total scan room time, scan completion without interruption, and change in child anxiety (mYPAS-SF). Additional prespecified measures include comfort/calmness Likert scales, Wong-Baker FACES pain, CEMS during scan, parent state anxiety, satisfaction VAS, physiologic vitals (heart rate, blood pressure, SpO₂) at defined peri-scan time points, observed crying and movement durations, and total scan duration. The trial uses parallel assignment with allocation concealment and masked outcome assessment. Analyses follow intention-to-treat with prespecified subgroup exploration by age bands (5-7 vs 8-10). Recruitment is planned for October 6, 2025; primary completion is expected within approximately three months.
Read the detailed description
Rationale. Pre-procedural anxiety in pediatric MRI is a well-recognized driver of motion, repetition of sequences, longer scanner occupancy, and sedation exposure. Brief, developmentally tailored exposure using a 360° VR module is hypothesized to reduce anxiety and movement through familiarization with scanner sounds, spatial constraints, and behavioral expectations.
Design Overview. Single-center, three-arm randomized clinical trial with parallel assignment and allocation concealment. Participants with no prior MRI experience are randomized 1:1:1 to Home+Booster VR, Pre-Scan VR only, or Usual Care. Outcome assessment is masked to allocation. Analyses follow intention-to-treat; per-protocol summaries are planned as supportive.
Intervention Content and Delivery. The VR module (~8-10 minutes) depicts arrival, positioning, acoustic noise, and the importance of remaining still. Narration and visuals are age-appropriate.
- Home+Booster VR: module viewed at home approximately 24-48 hours before MRI (re-view permitted), plus a brief on-site refresher immediately before positioning.
- Pre-Scan VR only: module viewed only on site immediately before positioning.
- Usual Care: standard institutional preparation without VR. Routine safety procedures and child-oriented coaching are applied uniformly across arms.
Adherence and Fidelity. Where available, platform logs capture timestamps and duration of module exposure (home and on-site). Staff document completion of on-site viewing and any technical issues. Periodic fidelity checks ensure consistent delivery.
Randomization, Masking, and Allocation Concealment. Randomization is performed via a concealed sequence (computer-generated permuted blocks). Allocation is revealed to staff immediately prior to preparation. Image-quality ratings are performed by a board-certified radiologist masked to allocation. Staff involved in VR delivery are not masked; contact with the assessor is minimized.
Safety Monitoring. VR is paused or discontinued for nausea, dizziness, or discomfort. Standard MRI safety screening is conducted per institutional policy. Adverse events related to VR exposure or MRI are recorded and reviewed by the study team; serious events are reported per institutional requirements.
Data Handling. Data are captured in secure, access-controlled case report forms with predefined range checks. Personally identifiable information is stored separately from analytic datasets. Quality control includes double-entry checks for a subset and automated logic checks.
Statistical Approach (brief). Descriptive statistics summarize baseline characteristics and feasibility metrics (e.g., adherence to the module). The primary endpoint (motion artifact score) is analyzed under intention-to-treat using appropriate ordinal or dichotomous models specified in the statistical analysis plan. Prespecified subgroup analyses examine age bands (5-7 vs 8-10). Multiplicity control procedures are detailed in the analysis plan. Missing data strategies are predefined and documented.
Timeline. Recruitment is planned to commence October 6, 2025. Enrollment and follow-up are expected to conclude within approximately three months, subject to scheduling logistics and scanner availability.
- Conditions
- Anxiety, Sedation, Child, Virtual Reality, MRI
- Being tested
- Virtual Reality Orientation (Home+Booster), Virtual Reality Orientation (Pre-Scan Only), Usual Care (No VR)
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Orientation (Home+Booster)Behavioural
Age-appropriate 360° VR module (~8-10 min) showing MRI room, sounds, positioning, and the importance of keeping still; viewed at home 24-48 h pre-scan on a smartphone/VR viewer (or flat 360° if no headset), plus a brief booster view on site immediately before positioning (~3-5 min refresher).
Virtual Reality Orientation (Pre-Scan Only)Behavioural
The same 360° VR module (~8-10 min) viewed once on site in the MRI area immediately before positioning; no home exposure.
Usual Care (No VR)Other
Standard institutional pediatric MRI preparation (verbal explanation, hearing protection demo, child-friendly coaching) without VR.
| Study group | Role | What they receive |
|---|---|---|
| Experimental - Home+Booster VR | Experimental | Home exposure 24-48 h pre-scan plus a brief on-site booster immediately before positioning. Receives: Behavioral: Virtual Reality Orientation (Home+Booster) |
| Pre-Scan VR Only | Experimental | Single on-site VR exposure immediately before positioning. Receives: Behavioral: Virtual Reality Orientation (Pre-Scan Only) |
| Usual Care | Active comparator | Standard pediatric MRI preparation without VR. Receives: Other: Usual Care (No VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiologist-Rated MRI Motion Artifact (ordinal score)
Motion artifact rated on a pre-specified 4-point ordinal scale per exam by a board-certified radiologist masked to allocation (0 = none; 1 = mild/not affecting diagnostic utility; 2 = moderate/partially limiting; 3 = severe/non-diagnostic). Inter-rater agreement (if applicable) will be summarized separately.
Unit of Measure: score (0-3)
Measured: During MRI session; assessment completed within 24 hours of image acquisition.
Secondary outcomes (2)
Diagnostic-Quality MRI Without Repeat or Sedation (yes/no)
Proportion of exams achieving diagnostic-quality images without repeated sequences and without sedation, based on pre-specified radiology/report criteria; ratings performed masked to allocation.
Unit of Measure: percent (%)
Measured: At completion of MRI session; determination recorded within 24 hours of image acquisition.
Total Scan Room Time
Time from room entry to room exit during the MRI session, including positioning and image acquisition.
Unit of Measure: minutes
Measured: During MRI session (room entry to room exit).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start6 Oct 2025 (estimated)
- Primary completion15 Jan 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berker Okay, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203716
- Sponsor's protocol ID
- 176-2025
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Spaendonck Z, Leeuwenburgh KP, Dremmen M, van Schuppen J, Starreveld D, Dierckx B, Legerstee JS. Comparing Smartphone Virtual Reality Exposure Preparation to Care as Usual in Children Aged 6 to 14 Years Undergoing Magnetic Resonance Imaging: Protocol for a Multicenter, Observer-Blinded, Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 24;12:e41080. doi: 10.2196/41080.
PubMed 36692931Harned RK 2nd, Strain JD. MRI-compatible audio/visual system: impact on pediatric sedation. Pediatr Radiol. 2001 Apr;31(4):247-50. doi: 10.1007/s002470100426.
PubMed 11321741Le May S, Genest C, Hung N, Francoeur M, Guingo E, Paquette J, Fortin O, Guay S. The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e30616. doi: 10.2196/30616.
PubMed 35700000Stunden C, Stratton K, Zakani S, Jacob J. Comparing a Virtual Reality-Based Simulation App (VR-MRI) With a Standard Preparatory Manual and Child Life Program for Improving Success and Reducing Anxiety During Pediatric Medical Imaging: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 22;23(9):e22942. doi: 10.2196/22942.
PubMed 34550072Ashmore J, Di Pietro J, Williams K, Stokes E, Symons A, Smith M, Clegg L, McGrath C. A Free Virtual Reality Experience to Prepare Pediatric Patients for Magnetic Resonance Imaging: Cross-Sectional Questionnaire Study. JMIR Pediatr Parent. 2019 Apr 18;2(1):e11684. doi: 10.2196/11684.
PubMed 31518319
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Home-Based and Immediate Pre-Scan Virtual Reality Orientation on Motion Artifacts and Sedation Need in Pediatric MRI: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07203716
- Acronym / sponsor ID
- 176-2025
- Conditions
- Anxiety, Sedation, Child, Virtual Reality, MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
Children frequently exhibit pre-MRI anxiety that can cause motion, repeated sequences, prolonged room time, and exposure to sedation. Orientation with Virtual Reality (VR) may reduce anxiety by familiarizing children with the scanner environment and expected sensations. This single-center, three-arm randomized clinical trial evaluates whether (1) Home+Booster VR (an age-appropriate 360° VR module at home ~24-48 hours before MRI plus a brief on-site refresher immediately before positioning), (2) Pre-Scan VR only (same module viewed on site immediately before positioning), or (3) Usual Care without VR improves MRI image quality and tolerance in children undergoing their first-ever MRI.
Eligible participants are children scheduled for clinically indicated, non-emergent MRI with no prior MRI experience. Major exclusions comprise MRI contraindications; contraindications to VR use (e.g., uncontrolled epilepsy or severe motion sickness); uncorrected severe visual/hearing impairment precluding VR viewing; and inability to provide assent/consent. After consent/assent, participants are randomized 1:1:1 to one of three arms. Anticipated enrollment is ~150 total (~50 per arm; up to 60 per arm if feasible). All arms receive routine safety procedures and child-oriented coaching per institutional practice. The VR module (~8-10 minutes) provides a 360° walkthrough of the MRI process (sounds, positioning, keeping still) with child-focused narration. Adherence (timestamps/duration) is recorded where applicable.
The primary outcome is motion artifact rated on a predefined ordinal scale by a board-certified radiologist masked to allocation; the proportion achieving diagnostic quality without repeat/sedation is also reported. Key secondary outcomes include sedation requirement, number of repeated sequences, total scan room time, scan completion without interruption, and change in child anxiety (mYPAS-SF). Additional prespecified measures include comfort/calmness Likert scales, Wong-Baker FACES pain, CEMS during scan, parent state anxiety, satisfaction VAS, physiologic vitals (heart rate, blood pressure, SpO₂) at defined peri-scan time points, observed crying and movement durations, and total scan duration. The trial uses parallel assignment with allocation concealment and masked outcome assessment. Analyses follow intention-to-treat with prespecified subgroup exploration by age bands (5-7 vs 8-10). Recruitment is planned for October 6, 2025; primary completion is expected within approximately three months.
Detailed description
Rationale. Pre-procedural anxiety in pediatric MRI is a well-recognized driver of motion, repetition of sequences, longer scanner occupancy, and sedation exposure. Brief, developmentally tailored exposure using a 360° VR module is hypothesized to reduce anxiety and movement through familiarization with scanner sounds, spatial constraints, and behavioral expectations.
Design Overview. Single-center, three-arm randomized clinical trial with parallel assignment and allocation concealment. Participants with no prior MRI experience are randomized 1:1:1 to Home+Booster VR, Pre-Scan VR only, or Usual Care. Outcome assessment is masked to allocation. Analyses follow intention-to-treat; per-protocol summaries are planned as supportive.
Intervention Content and Delivery. The VR module (~8-10 minutes) depicts arrival, positioning, acoustic noise, and the importance of remaining still. Narration and visuals are age-appropriate.
- Home+Booster VR: module viewed at home approximately 24-48 hours before MRI (re-view permitted), plus a brief on-site refresher immediately before positioning.
- Pre-Scan VR only: module viewed only on site immediately before positioning.
- Usual Care: standard institutional preparation without VR. Routine safety procedures and child-oriented coaching are applied uniformly across arms.
Adherence and Fidelity. Where available, platform logs capture timestamps and duration of module exposure (home and on-site). Staff document completion of on-site viewing and any technical issues. Periodic fidelity checks ensure consistent delivery.
Randomization, Masking, and Allocation Concealment. Randomization is performed via a concealed sequence (computer-generated permuted blocks). Allocation is revealed to staff immediately prior to preparation. Image-quality ratings are performed by a board-certified radiologist masked to allocation. Staff involved in VR delivery are not masked; contact with the assessor is minimized.
Safety Monitoring. VR is paused or discontinued for nausea, dizziness, or discomfort. Standard MRI safety screening is conducted per institutional policy. Adverse events related to VR exposure or MRI are recorded and reviewed by the study team; serious events are reported per institutional requirements.
Data Handling. Data are captured in secure, access-controlled case report forms with predefined range checks. Personally identifiable information is stored separately from analytic datasets. Quality control includes double-entry checks for a subset and automated logic checks.
Statistical Approach (brief). Descriptive statistics summarize baseline characteristics and feasibility metrics (e.g., adherence to the module). The primary endpoint (motion artifact score) is analyzed under intention-to-treat using appropriate ordinal or dichotomous models specified in the statistical analysis plan. Prespecified subgroup analyses examine age bands (5-7 vs 8-10). Multiplicity control procedures are detailed in the analysis plan. Missing data strategies are predefined and documented.
Timeline. Recruitment is planned to commence October 6, 2025. Enrollment and follow-up are expected to conclude within approximately three months, subject to scheduling logistics and scanner availability.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental - Home+Booster VR | Experimental | Behavioral: Virtual Reality Orientation (Home+Booster)Home exposure 24-48 h pre-scan plus a brief on-site booster immediately before positioning. |
| Pre-Scan VR Only | Experimental | Behavioral: Virtual Reality Orientation (Pre-Scan Only)Single on-site VR exposure immediately before positioning. |
| Usual Care | Active comparator | Other: Usual Care (No VR)Standard pediatric MRI preparation without VR. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children 5 to 10 years old (inclusive).
- First-ever MRI for a clinically indicated, non-emergent examination (outpatient or elective inpatient).
- Ability to view the age-appropriate 360° VR module (head-mounted viewer or flat 360° on screen) with basic comprehension of instructions (child and/or caregiver in Turkish).
- Parental/guardian informed consent and child assent per age/competence.
- Standard MRI safety screening passed; institutional rescue sedation policies remain available if clinically required.
Key exclusion criteria (7 listed)
- MRI contraindications (e.g., non-MR-conditional implants, unsafe metallic foreign bodies).
- Pre-planned sedation or general anesthesia irrespective of behavior (clinician decision made prior to randomization).
- Conditions contraindicating VR exposure (e.g., uncontrolled epilepsy, severe motion sickness/vertigo causing intolerance).
- Severe uncorrected visual or hearing impairment precluding module viewing or instruction adherence.
- Emergent/urgent MRI where study procedures could delay care.
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 |
|---|---|---|
| Virtual Reality Orientation (Home+Booster)Age-appropriate 360° VR module (~8-10 min) showing MRI room, sounds, positioning, and the importance of keeping still; viewed at home 24-48 h pre-scan on a smartphone/VR viewer (or flat 360° if no headset), plus a brief booster view on site immediately before positioning (~3-5 min refresher). | Behavioural | Experimental - Home+Booster VR |
| Virtual Reality Orientation (Pre-Scan Only)The same 360° VR module (~8-10 min) viewed once on site in the MRI area immediately before positioning; no home exposure. | Behavioural | Pre-Scan VR Only |
| Usual Care (No VR)Standard institutional pediatric MRI preparation (verbal explanation, hearing protection demo, child-friendly coaching) without VR. | Other | Usual Care |
Primary outcome
Radiologist-Rated MRI Motion Artifact (ordinal score)
Time frame: During MRI session; assessment completed within 24 hours of image acquisition.
Motion artifact rated on a pre-specified 4-point ordinal scale per exam by a board-certified radiologist masked to allocation (0 = none; 1 = mild/not affecting diagnostic utility; 2 = moderate/partially limiting; 3 = severe/non-diagnostic). Inter-rater agreement (if applicable) will be summarized separately. Unit of Measure: score (0-3)
2 secondary outcomes
Diagnostic-Quality MRI Without Repeat or Sedation (yes/no)
Time frame: At completion of MRI session; determination recorded within 24 hours of image acquisition.
Total Scan Room Time
Time frame: During MRI session (room entry to room exit).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Background: PubMed 36692931van Spaendonck Z, Leeuwenburgh KP, Dremmen M, van Schuppen J, Starreveld D, Dierckx B, Legerstee JS. Comparing Smartphone Virtual Reality Exposure Preparation to Care as Usual in Children Aged 6 to 14 Years Undergoing Magnetic Resonance Imaging: Protocol for a Multicenter, Observer-Blinded, Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 24;12:e41080. doi: 10.2196/41080.
- Background: PubMed 11321741Harned RK 2nd, Strain JD. MRI-compatible audio/visual system: impact on pediatric sedation. Pediatr Radiol. 2001 Apr;31(4):247-50. doi: 10.1007/s002470100426.
- Background: PubMed 35700000Le May S, Genest C, Hung N, Francoeur M, Guingo E, Paquette J, Fortin O, Guay S. The Efficacy of Virtual Reality Game Preparation for Children Scheduled for Magnetic Resonance Imaging Procedures (IMAGINE): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Jun 13;11(6):e30616. doi: 10.2196/30616.
- Background: PubMed 34550072Stunden C, Stratton K, Zakani S, Jacob J. Comparing a Virtual Reality-Based Simulation App (VR-MRI) With a Standard Preparatory Manual and Child Life Program for Improving Success and Reducing Anxiety During Pediatric Medical Imaging: Randomized Clinical Trial. J Med Internet Res. 2021 Sep 22;23(9):e22942. doi: 10.2196/22942.
- Background: PubMed 31518319Ashmore J, Di Pietro J, Williams K, Stokes E, Symons A, Smith M, Clegg L, McGrath C. A Free Virtual Reality Experience to Prepare Pediatric Patients for Magnetic Resonance Imaging: Cross-Sectional Questionnaire Study. JMIR Pediatr Parent. 2019 Apr 18;2(1):e11684. doi: 10.2196/11684.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Orientation (Home+Booster) and Virtual Reality Orientation (Pre-Scan Only) in people with Anxiety and Sedation, run by Haseki Training and Research Hospital.
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 7 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: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Radiologist-Rated MRI Motion Artifact (ordinal score) (time frame: During MRI session; assessment completed within 24 hours of image acquisition.). 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 NCT07203716, which also lists 5 linked publications.
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 2 Oct 2025.