All Conditions for Which a CT or MRI Exam Can be RequiredVERTIMNCT03266523
Influence of Natural Images on Patients' Anxiety in the Waiting Rooms of Imaging Ward
An observational study of All Conditions for Which a CT or MRI Exam Can be Required, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All Conditions for Which a CT or MRI Exam Can be Required
- What is being tested?
- Natural images in imaging waiting rooms
- How many people
- 418 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2017to 15 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Natural images in imaging waiting rooms
- Keywords
- CT, MRI, Anxiety-state, Anxiety State-Trait
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural images in imaging waiting roomsOther
Also called Neutral
Standard environment for hospital imaging waiting rooms
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Natural images in imaging waiting rooms | |
| Green | The GREEN environment will represent rural landscapes, undergrowth Receives: Other: Natural images in imaging waiting rooms | |
| Sea | The SEA environment will represent lakes, ponds, seaside Receives: Other: Natural images in imaging waiting rooms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of the scores of anxiety-State (STAI-Y).
Measured: The day the patient waits in the imaging waiting room
Secondary outcomes (14)
Average of the scores of emotional perception for the various esthetic approaches
Measured: The day the patient waits in the imaging waiting room
Scores of the anxiety-trait in each of the subgroups
Measured: The day the patient waits in the imaging waiting room
Scores of satisfaction for the various esthetic approaches
Measured: 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
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)
Measured: The day the patient waits in the imaging waiting room
Reliability of the tool: coefficient alpha of Cronbach, or coefficient α ≥ 0,7.
Measured: The day the patient waits in the imaging waiting room
Reason for MRI or scanner's prescription
Measured: The day the patient waits in the imaging waiting room
Anxiolytic treatment and / or antidepressants (regular intake)
Measured: The day the patient waits in the imaging waiting room
Anxiolytic treatment (specific prescription for examination)
Measured: The day the patient waits in the imaging waiting room
gender
Measured: The day the patient waits in the imaging waiting room
age
Measured: The day the patient waits in the imaging waiting room
Level of education
Measured: The day the patient waits in the imaging waiting room
professional category
Measured: The day the patient waits in the imaging waiting room
Type of housing
house or building, floor, elevator, garden, ...
Measured: The day the patient waits in the imaging waiting room
Lifestyle
urban, rural
Measured: The day the patient waits in the imaging waiting room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start3 Oct 2017
- Primary completion15 Dec 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Conditions for Which a CT or MRI Exam Can be RequiredStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03266523
- Sponsor's protocol ID
- CHUBX 2016/49
- Acronym
- VERTIM
- Status last verified
- Dec 2017
- First submitted
- 12 Jul 2017
- Last updated
- 27 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03266523
- Acronym / sponsor ID
- VERTIM / CHUBX 2016/49
- Keywords
- CT, MRI, Anxiety-state, Anxiety State-Trait
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 30 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | –The CONTROL (neutral) environment corresponds to the standard environment of the imaging waiting rooms |
| Zen | – | Other: Natural images in imaging waiting roomsThe ZEN environment will represent a clean, minimalist nature |
| Green | – | Other: Natural images in imaging waiting roomsThe GREEN environment will represent rural landscapes, undergrowth |
| Sea | – | Other: Natural images in imaging waiting roomsThe SEA environment will represent lakes, ponds, seaside |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural images in imaging waiting roomsAlso: NeutralStandard environment for hospital imaging waiting rooms | Other | Green, Sea, Zen |
Primary outcome
Average of the scores of anxiety-State (STAI-Y).
Time frame: The day the patient waits in the imaging waiting room
14 secondary outcomes
Average of the scores of emotional perception for the various esthetic approaches
Time frame: 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
Scores of satisfaction for the various esthetic approaches
Time frame: 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
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
Reason for MRI or scanner's prescription
Time frame: 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
Anxiolytic treatment (specific prescription for examination)
Time frame: The day the patient waits in the imaging waiting room
gender
Time frame: The day the patient waits in the imaging waiting room
age
Time frame: 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
professional category
Time frame: 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
Lifestyle
Time frame: The day the patient waits in the imaging waiting room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of All Conditions for Which a CT or MRI Exam Can be Required, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average of the scores of anxiety-State (STAI-Y). (time frame: The day the patient waits in the imaging waiting room). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2017.