Clinical trial NCT03266523: Influence of Natural Images on Patients' Anxiety in the Waiting Rooms of Imaging Ward
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Conditions for Which a CT or MRI Exam Can be Required
Keywords: CT
MRI
Anxiety-state
Anxiety State-Trait
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants are major patients who will be present in the waiting room of the MRI or the scanner in order to carry out one of these two exams

Brief summary: VERTIM study aims to evaluate the influence of different environments of imaging waiting rooms on the anxiety felt by patients before MRI or CT scans. For this, four environments (neutral/standard; and nature "green", "sea", and "zen") will be set up in MRI and CT waiting rooms.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average of the scores of anxiety-State (STAI-Y).
timeFrame: The day the patient waits in the imaging waiting room
Secondary outcomes:
measure: Average of the scores of emotional perception for the various esthetic approaches
timeFrame: The day the patient waits in the imaging waiting room
measure: Scores of the anxiety-trait in each of the subgroups
timeFrame: The day the patient waits in the imaging waiting room
measure: Scores of satisfaction for the various esthetic approaches
timeFrame: The day the patient waits in the imaging waiting room
measure: Strength of the interaction between emotional perception *environnement to explain the level of anxiety State
timeFrame: The day the patient waits in the imaging waiting room
measure: Reliability of the tool: coefficient alpha of Cronbach, or coefficient α ≥ 0,7.
timeFrame: The day the patient waits in the imaging waiting room
measure: Reason for MRI or scanner's prescription
timeFrame: The day the patient waits in the imaging waiting room
measure: Anxiolytic treatment and / or antidepressants (regular intake)
timeFrame: The day the patient waits in the imaging waiting room
measure: Anxiolytic treatment (specific prescription for examination)
timeFrame: The day the patient waits in the imaging waiting room
measure: gender
timeFrame: The day the patient waits in the imaging waiting room
measure: age
timeFrame: The day the patient waits in the imaging waiting room
measure: Level of education
timeFrame: The day the patient waits in the imaging waiting room
measure: professional category
timeFrame: The day the patient waits in the imaging waiting room
measure: Type of housing
timeFrame: The day the patient waits in the imaging waiting room
measure: Lifestyle
timeFrame: The day the patient waits in the imaging waiting room
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Hopital Pellegrin
Study officials:
References: