- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03266523
Influence of Natural Images on Patients' Anxiety in the Waiting Rooms of Imaging Ward (VERTIM)
Pilot Study on the Influence of the Integration of Natural Images, According to Various Esthetic Approaches, in the Waiting Rooms of Imaging on the Anxiety Felt by the Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
Each year, the Medical Imaging Unit of the University Hospital of Bordeaux (CHU Bordeaux) receives 80,500 patients for CT or MRI scans in usual care. The length of waiting, the environment of the waiting room, the reasons for the examination are factors that increase the levels of anxiety during waiting and but also during early examination.
Previous studies have shown that the integration of nature (real as well as artificial) is likely to decrease the level of anxiety. Before implementing a multicentre and randomised trial, a pilot study is necessary to assess the feasibility of the procedure, to test the relevance of the tools, to identify the influence of socio-cultural and socio-demographic characteristics on anxiety's level.
For this, the present study will be conducted over the same period of the year in order to avoid seasonality biases. The study will take place over 8 weeks, during which MRI or scanner patients will be exposed either to the neutral environment (standard environment of the waiting room) or to one of the 3 environments (wall posters representing the nature ("green", "sea", "zen")).
There is no specific intervention assigned to the study participants, i.e. the patients will receive one of the four environments as part of routine medical care, and a researcher studies the effect of this environment on anxiety's level. Every week, one environment will be set up in the MRI or scanner waiting room and the study will be proposed to all eligible patients present in this room. Fifty patients are expected each week so that 100 patients per environment and equally distributed between the MRI and scanner waiting rooms are expected.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bordeaux, France, 33076
- Hopital Pellegrin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patient 18 yrs and older;
- patients in MRI or scanner's waiting room awaiting one of these 2 exams;
- patients not objecting to answer questionnaires;
- patient covered under social security
Exclusion Criteria:
- patient <18yrs old;
- patients with hearing and visual impairments;
- patients unable to answer questionnaires;
- patients awaiting for other exams than MRI or scanner;
- legally protected patient
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control
The CONTROL (neutral) environment corresponds to the standard environment of the imaging waiting rooms
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Zen
The ZEN environment will represent a clean, minimalist nature
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Standard environment for hospital imaging waiting rooms
Other Names:
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Green
The GREEN environment will represent rural landscapes, undergrowth
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Standard environment for hospital imaging waiting rooms
Other Names:
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Sea
The SEA environment will represent lakes, ponds, seaside
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Standard environment for hospital imaging waiting rooms
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average of the scores of anxiety-State (STAI-Y).
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average of the scores of emotional perception for the various esthetic approaches
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Scores of the anxiety-trait in each of the subgroups
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Scores of satisfaction for the various esthetic approaches
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Strength of the interaction between emotional perception *environnement to explain the level of anxiety State
Time Frame: The day the patient waits in the imaging waiting room
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This outcome is measured through the scores of emotional perception (emotional perception), the nature of environment applied (control, zen, green or sea) and the STAI-Y scale score (level of state anxiety)
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The day the patient waits in the imaging waiting room
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Reliability of the tool: coefficient alpha of Cronbach, or coefficient α ≥ 0,7.
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Reason for MRI or scanner's prescription
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Anxiolytic treatment and / or antidepressants (regular intake)
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Anxiolytic treatment (specific prescription for examination)
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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gender
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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age
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Level of education
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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professional category
Time Frame: The day the patient waits in the imaging waiting room
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The day the patient waits in the imaging waiting room
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Type of housing
Time Frame: The day the patient waits in the imaging waiting room
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house or building, floor, elevator, garden, ...
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The day the patient waits in the imaging waiting room
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Lifestyle
Time Frame: The day the patient waits in the imaging waiting room
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urban, rural
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The day the patient waits in the imaging waiting room
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2016/49
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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