BehaviorNCT05089955
Children's MRI Experience
A study testing Ambient Experience in people with Behavior and Psychological Distress, run by Philips Clinical & Medical Affairs Global at 6 sites in 6 countries.
Trial summary
The study aims to investigate the effect of Philips Ambient Experience with specially designed paediatric content on the experience of pediatric patients undergoing an MRI examination, their caregiver, and clinical staff, on workflow and on clinical outcome. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Behavior, Psychological Distress, Anxiety
- What is being tested?
- Ambient Experience
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 24 Jan 2023to 29 May 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients between 6 and 12 years old
- Scheduled for a head-first MRI scan
- Parent/guardian and child speak and read the local language.
- Positive judgement by on-site PI/(co-) investigator for awake scanning
Who cannot join
- General anesthesia
- Clinically diagnosed cognitive, or developmental disorder (e.g. ADHD, ASD) or neurological problems that prevent the ability to lie/hold still for an MRI scan while awake
- Previous MRI examination with Philips Ambient Experience
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Germany1 site
Das Universitätsklinikum Bonn (UKB)
Bonn, North Rhine-Westphalia, 53127
Poland1 site
Polish Mother's Hospital / Institute of Polish Mother's Health Center
Lodz, 93-338
Spain1 site
Hospital de Sant Joan de Déu Barcelona
Esplugues de Llobregat, Barcelona, 08950
About this study
Official title: User Evaluation New Ambient Experience Content
The study aims to investigate the effect of Philips Ambient Experience with specially designed paediatric content on the experience of pediatric patients undergoing an MRI examination, their caregiver, and clinical staff, on workflow and on clinical outcome. The designed paediatric content exists of personal selection of a character, video projection on the wall and/or a screen visible when in the bore, audio, and room ambience lighting.
The study will be conducted in collaboration with six partner hospitals within the EU. At each hospital, 50 pediatric patients between 6 and 12 years old will be included in the study.
- Conditions
- Behavior, Psychological Distress, Anxiety
- Being tested
- Ambient Experience
- Medical subject headings
- Behavior, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambient ExperienceBehavioural
MRI examination with Ambient Experience
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | MRI examination with Ambient Experience with paediatric content Receives: Behavioral: Ambient Experience |
| Control group | No intervention | MRI examination without Ambient Experience (standard of care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child anxiety level
Change of anxiety experienced by the child, measured with questions before and after the scan. A Venham picture preference scale will be used, the range is not applicable as it indicates their state of anxiety.
Measured: The visit on the imaging department; before and after the examination. This is estimated to be 30 up to 60 minutes, depending on the MRI scans that have to be made.
Child anxiety level
Change of anxiety level of child measured with an observational scale by staff or (co-) investigator before and during the scan. By using a modified yale preoperative anxiety scale, with a range from 22.92 to 100; higher values indicating greater anxiety.
Measured: The visit on the imaging department; before and during the examination. This is estimated to be 10 up to 30 minutes, depending on the MRI scans that have to be made.
Secondary outcomes (2)
Immersiveness and engagement with Ambient Experience and content
Measured with likability of the experience and characters. This scale is self-constructed for the purpose of measuring how much the child likes the characters and how much that influenced their experience of the scan.
Measured: After the scan, 5 minutes.
Parent/ Guardian satisfaction
Will be measured with self-constructed 6-point Likert scale, with higher ratings indicating a higher satisfaction.
Measured: After the scan, 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start24 Jan 2023
- Primary completion26 Apr 2024
- Study completion29 May 2024
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 BehaviorStudies 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
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sanae van der Vleuten- Chraibi, Study director, Philips Clinical & Medical Affairs Global
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089955
- Sponsor's protocol ID
- ICBE-S-000195
- Status last verified
- Aug 2024
- First submitted
- 10 Sep 2021
- Last updated
- 15 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van der Vleuten-Chraibi S, Nauts S, Baranska D, Inarejos Clemente EJ, Sterup Bovin J, Najafi N, Luetkens JA, Alison M, Biermann HM, Peckman F, Saini P. Magnetic resonance imaging related anxiety and workflow: impact of a child-friendly audio-visual intervention. Pediatr Radiol. 2025 Aug;55(9):1934-1942. doi: 10.1007/s00247-025-06308-0. Epub 2025 Jul 4.
PubMed 40613840
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- User Evaluation New Ambient Experience Content
- ClinicalTrials.gov ID
- NCT05089955
- Acronym / sponsor ID
- ICBE-S-000195
- Conditions
- Behavior, Psychological Distress, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 22 Oct 2021 (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.
The study aims to investigate the effect of Philips Ambient Experience with specially designed paediatric content on the experience of pediatric patients undergoing an MRI examination, their caregiver, and clinical staff, on workflow and on clinical outcome. The designed paediatric content exists of personal selection of a character, video projection on the wall and/or a screen visible when in the bore, audio, and room ambience lighting.
The study will be conducted in collaboration with six partner hospitals within the EU. At each hospital, 50 pediatric patients between 6 and 12 years old will be included in the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Ambient ExperienceMRI examination with Ambient Experience with paediatric content |
| Control group | No intervention | –MRI examination without Ambient Experience (standard of care) |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients between 6 and 12 years old
- Scheduled for a head-first MRI scan
- Parent/guardian and child speak and read the local language.
- Positive judgement by on-site PI/(co-) investigator for awake scanning
Key exclusion criteria (3 listed)
- General anesthesia
- Clinically diagnosed cognitive, or developmental disorder (e.g. ADHD, ASD) or neurological problems that prevent the ability to lie/hold still for an MRI scan while awake
- Previous MRI examination with Philips Ambient Experience
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 |
|---|---|---|
| Ambient ExperienceMRI examination with Ambient Experience | Behavioural | Intervention group |
Primary outcome
Child anxiety level
Time frame: The visit on the imaging department; before and after the examination. This is estimated to be 30 up to 60 minutes, depending on the MRI scans that have to be made.
Change of anxiety experienced by the child, measured with questions before and after the scan. A Venham picture preference scale will be used, the range is not applicable as it indicates their state of anxiety.
Child anxiety level
Time frame: The visit on the imaging department; before and during the examination. This is estimated to be 10 up to 30 minutes, depending on the MRI scans that have to be made.
Change of anxiety level of child measured with an observational scale by staff or (co-) investigator before and during the scan. By using a modified yale preoperative anxiety scale, with a range from 22.92 to 100; higher values indicating greater anxiety.
2 secondary outcomes
Immersiveness and engagement with Ambient Experience and content
Time frame: After the scan, 5 minutes.
Parent/ Guardian satisfaction
Time frame: After the scan, 5 minutes
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 Aug 2024.
- Derived from this study: PubMed 40613840van der Vleuten-Chraibi S, Nauts S, Baranska D, Inarejos Clemente EJ, Sterup Bovin J, Najafi N, Luetkens JA, Alison M, Biermann HM, Peckman F, Saini P. Magnetic resonance imaging related anxiety and workflow: impact of a child-friendly audio-visual intervention. Pediatr Radiol. 2025 Aug;55(9):1934-1942. doi: 10.1007/s00247-025-06308-0. Epub 2025 Jul 4.
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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.
Sanae van der Vleuten- Chraibi study director
Philips Clinical & Medical Affairs Global
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambient Experience in people with Behavior and Psychological Distress, run by Philips Clinical & Medical Affairs Global at 6 sites in 6 countries.
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 4 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 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Denmark, France, Germany, Poland and 1 more country. 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 level (time frame: The visit on the imaging department; before and after the examination. This is estimated to be 30 up to 60 minutes, depending on the MRI scans that have to be made.). The study lists 2 primary outcomes in all. 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 NCT05089955, 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 15 Aug 2024.