Influence of Natural Images on Patients' Anxiety in the Waiting Rooms of Imaging Ward (VERTIM)

December 26, 2017 updated by: University Hospital, Bordeaux

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

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.

Study Overview

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

Observational

Enrollment (Actual)

418

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France, 33076
        • Hopital Pellegrin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Zen
The ZEN environment will represent a clean, minimalist nature
Standard environment for hospital imaging waiting rooms
Other Names:
  • Neutral
Green
The GREEN environment will represent rural landscapes, undergrowth
Standard environment for hospital imaging waiting rooms
Other Names:
  • Neutral
Sea
The SEA environment will represent lakes, ponds, seaside
Standard environment for hospital imaging waiting rooms
Other Names:
  • Neutral

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
The day the patient waits in the imaging waiting room

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
The day the patient waits in the imaging waiting room
Scores of the anxiety-trait in each of the subgroups
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
Scores of satisfaction for the various esthetic approaches
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
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
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
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
The day the patient waits in the imaging waiting room
Reason for MRI or scanner's prescription
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
Anxiolytic treatment and / or antidepressants (regular intake)
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
Anxiolytic treatment (specific prescription for examination)
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
gender
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
age
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
Level of education
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
professional category
Time Frame: The day the patient waits in the imaging waiting room
The day the patient waits in the imaging waiting room
Type of housing
Time Frame: The day the patient waits in the imaging waiting room
house or building, floor, elevator, garden, ...
The day the patient waits in the imaging waiting room
Lifestyle
Time Frame: The day the patient waits in the imaging waiting room
urban, rural
The day the patient waits in the imaging waiting room

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Actual)

December 15, 2017

Study Completion (Actual)

December 15, 2017

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

August 25, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 26, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2016/49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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