Anxiety Clinical Trial
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | June 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel | Jette | Brussels |
Denmark | Herlev Hospital | Herlev | |
France | Hôpital Robert Debré Paris | Paris | |
Germany | Das Universitätsklinikum Bonn (UKB) | Bonn | Nordrhein-Westfalen |
Poland | Polish Mother's Hospital / Institute of Polish Mother's Health Center | Lódz | |
Spain | Hospital de Sant Joan de Déu Barcelona | Esplugues De Llobregat | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Philips Electronics Nederland B.V. acting through Philips CTO organization |
Belgium, Denmark, France, Germany, Poland, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Staff experience with the ambient experience system and workflow satisfaction | Measured by using self-constructered items, 5 point Likert scales, with higher ratings indicating a better experience and higher satisfaction. | At study start 5 min. and study end 5 min. | |
Other | Observed operational efficiency | Observed cooperation of the patient and duration of preparing the patient for the MRI examination.This will be measured by using 5-point Likert scales, with higher ratings indicating a lower efficiency. | 5 minutes depending on the MRI scans that have to be made | |
Other | Measured operational efficiency | Duration of the MRI examination, number of rescans required, and number of pauzes required. Numerical log data derived from the MRI server. | 30 up to 60 minutes depending on the entire length of the MRI scans that have to be made | |
Other | Clinical patient outcome | Reported image quality by the MRI tech and the ability to perform the planned awake scan successful or not | During MRI scan, ca 30 minutes | |
Primary | 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. | 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. | |
Primary | 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. | 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 | 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. | After the scan, 5 minutes. | |
Secondary | Parent/ Guardian satisfaction | Will be measured with self-constructed 6-point Likert scale, with higher ratings indicating a higher satisfaction. | After the scan, 5 minutes |
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