Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03266523
Other study ID # CHUBX 2016/49
Secondary ID
Status Completed
Phase N/A
First received July 12, 2017
Last updated December 26, 2017
Start date October 3, 2017
Est. completion date December 15, 2017

Study information

Verified date December 2017
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 418
Est. completion date December 15, 2017
Est. primary completion date December 15, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • All Conditions for Which a CT or MRI Exam Can be Required

Intervention

Other:
Natural images in imaging waiting rooms
Standard environment for hospital imaging waiting rooms

Locations

Country Name City State
France Hopital Pellegrin Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average of the scores of anxiety-State (STAI-Y). The day the patient waits in the imaging waiting room
Secondary Average of the scores of emotional perception for the various esthetic approaches The day the patient waits in the imaging waiting room
Secondary Scores of the anxiety-trait in each of the subgroups The day the patient waits in the imaging waiting room
Secondary Scores of satisfaction for the various esthetic approaches The day the patient waits in the imaging waiting room
Secondary Strength of the interaction between emotional perception *environnement to explain the level of anxiety State 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) The day the patient waits in the imaging waiting room
Secondary Reliability of the tool: coefficient alpha of Cronbach, or coefficient a = 0,7. The day the patient waits in the imaging waiting room
Secondary Reason for MRI or scanner's prescription The day the patient waits in the imaging waiting room
Secondary Anxiolytic treatment and / or antidepressants (regular intake) The day the patient waits in the imaging waiting room
Secondary Anxiolytic treatment (specific prescription for examination) The day the patient waits in the imaging waiting room
Secondary gender The day the patient waits in the imaging waiting room
Secondary age The day the patient waits in the imaging waiting room
Secondary Level of education The day the patient waits in the imaging waiting room
Secondary professional category The day the patient waits in the imaging waiting room
Secondary Type of housing house or building, floor, elevator, garden, ... The day the patient waits in the imaging waiting room
Secondary Lifestyle urban, rural The day the patient waits in the imaging waiting room