StressSkyceilingNCT01667705
To Examine the Effect of a View of Nature on Patient's Stress and Anxiety
An observational study of Stress and Anxiety, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Recently, research that demonstrates a clear relationship between the built healthcare environment and the health and wellbeing of patients has come available. Patients in a CT scan suite are usually anxious. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- How many people
- 120 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2012to Dec 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120 Out-patients, age 18-85, who are scheduled to undergo a thorax and/or abdomen CT scan with intravenous contrast.
Who may be able to join
- Age 18-85
- Able to read and write Dutch
- Able to observe the visual stimuli applied to the ceiling, i.e. normal vision or corrected to normal vision.
Who cannot join
- Patients who have undergone a CT scan after the SkyCeiling was installed (this is a rare event) are excluded. This because of the fact that these patients might remember the look of the CT unit either with or without the SkyCeiling and could thus become more aware of the intended anxiety-reducing effect of the intervention, or the lack thereof if randomized to the control group.
- Patients who undergo a second scan during the run time of this study (this will be a rare event) will not be included a second time. The data of their first scan remain included.
- Patients who lie with their face down or are otherwise incapable of looking at the ceiling will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Experience in the CT Scan Suite
- Rationale: Recently, research that demonstrates a clear relationship between the built healthcare environment and the health and wellbeing of patients has come available. Patients in a CT scan suite are usually anxious. The environment has been shown to lower stress; a painting or piece of art for example, can capture and hold attention and thereby lower negative thoughts and evoke positive emotions. Sights of nature have demonstrated to be especially effective in recuperating from stress, presumably because the human brain has evolved in a natural environment. The current study will investigate the effects of exposure to nature in the CT scan suite. A SkyCeiling, a large, slightly illuminated, photographic illusion of a real sky view is placed above the CT scan. The main hypothesis of this study is that a sky view will lead to a lower level of anxiety in the CT scan suite.
- Objective: The primary objective of this study is to examine the effect of a view of nature on a patient's stress and anxiety. Secondary objectives are to study the effects of a view of nature on a patient's environmental appraisals of the CT suite, satisfaction with the provided service, and trust in the healthcare provider.
Read the detailed description
- INTRODUCTION AND RATIONALE The importance and the potential benefits of well-designed healthcare facilities have been widely acknowledged and recent research clearly demonstrates the relationship between the built healthcare environment and patients' health and well-being (Dijkstra, 2009). Encounters with healthcare situations are generally characterized by fear, anxiety, stress, and uncertainty (Mitchell, 2003; Pearson, Maddern, \& Fitridge, 2005). Looking at most environments in which these encounters take place, one might rightfully ask how well these healthcare environments satisfy the psychological needs of patients. In order to create more beneficial environments, environmental stimuli can be added to (or removed from) the environment to influence the patient in a positive manner. The environment may elicit positive feelings, hold attention and interest, and block or reduce negative thoughts, for example, by the presence of art or a view from a window (R. S. Ulrich, 1984). The purpose of the present study is to improve patients' well-being by adding positive elements to existing healthcare environments, such as pictures of nature. Stress is an important factor in healthcare situations and stress reactions can be considered a clinical problem since they often result in negative or worsened medical outcomes (Malkin, 2008). Previous studies (Volicer \& Volicer, 1978), for example, found that hospital stress was correlated with changes in heart rate and blood pressure. Other studies showed that psychological stress impairs wound healing in patients (Christian, Graham, Padgett, Glaser, \& Kiecolt-Glaser, 2006; Kiecolt-Glaser, Marucha, Malarkey, Mercado, \& Glaser, 1995). Elbrecht and colleagues (Elbrecht et al., 2004) studied the effects of perceived stress and cortisol levels on wound healing and demonstrated a considerable negative effect of stress. Rabin (2004 in Malkin 2008; personal communication 2008) proposed that pleasant healthcare environments are those that are perceived by the brain as calming, meaning that the stress reactive areas of the brain decrease their activity with a resultant decrease in the concentration of cortisol and norepinephrine in the blood. This results in patients experiencing less pain, having more restful sleep, less anger, less muscle tension, and a lower risk of stroke. Furthermore, Kaplan and Kaplan (R. Kaplan \& Kaplan, 1989) state that "the nervous system seems to be structured in such a way that pleasure and pain tend to inhibit each other". A more pleasant healthcare environment could, therefore, result in less stress and anxiety in patients and this should lead to better health and increased feelings of well-being. When speaking about a more pleasant healthcare environment, a wide variety of environmental characteristics come to mind. Variables such as indoor plants and music could help create environments that generate positive feelings and, as a consequence, reduce negative outcomes. Nonpharmacological anti-anxiety interventions The advantage of using environmental interventions to lower anxiety is that these kind of interventions do not carry any risk and are not time consuming. Several studies have examined various methods of anxiety reduction in healthcare environments. For example, research has demonstrated the beneficial effects of scents on anxiety and mood in dental patients (Lehrner, Eckersberger, Walla, Poetsch, \& Deecke, 2000; Lehrner, Marwinski, Lehr, Johren, \& Deecke, 2005) Furthermore, music therapy has successfully been applied to reduce pain and anxiety in patients undergoing various medical procedures, such as children with cancer undergoing lumbar puncture (Thanh Nhan, Nilsson, Hellström, \& Bengtson, 2010) and women during caesarian delivery (Chang \& Chen, 2005). Sunlight appeared to have beneficial effects on perceived stress (Walch et al., 2005). A recent study (Park \& Mattson, 2009) demonstrated that indoor plants in a hospital room can have therapeutic value and serve as a noninvasive and effective complementary medicine for surgical patients. Esthetic enhancements can thus provide unobtrusive and inexpensive stress and anxiety management methods. In this study we propose nature as an anti-anxiety intervention, which possibly has an even stronger effect on anxiety then scent, daylight or music. Nature interventions Research on restorative environments suggests that certain environments are capable of promoting recovery from stress. Especially natural settings have these restorative effects (Hartig, Book, Garvill, Olsson, \& Garling, 1996). Considering the potential healing properties of nature (Lohr \& Pearson-Mims, 2000; R. S. Ulrich, 1984), exposing patients to natural elements may be an effective way of reducing stress. A recent review concluded that viewing nature scenes may decrease pain perceptions by eliciting positive emotional responses and decreasing stress (Malenbaum, Keefe, Williams, Ulrich, \& Somers, 2008). Ulrich et al. (R. Ulrich et al., 1991) studied the effects of exposure to nature on stress recovery. Participants watched a videotape that induced feelings of stress, and were afterwards exposed to a tape with either a natural or an urban environment. Results demonstrated that individuals recover sooner from stress when exposed to the former (natural) than the latter (urban). Lohr and Pearson-Mims (2000) studied whether the presence of indoor plants would increase pain tolerance. Participants were either placed in a room with plants, a room with non-plant objects (as visually distractive as the plants), or a control room (no objects). Results showed that a significantly larger proportion of respondents in the room with plants were able to keep their hand in the ice water for 5 minutes as compared to the other conditions, suggesting increased pain tolerance by exposure to indoor plants. They also showed that the room with plants was rated more positively (e.g., cheerful, calming, pleasant) than either of the control rooms. The results of these studies support the idea that nature may have beneficial effects on the health and well-being of people. Natural elements in the built environment have clearly shown stress-reducing properties, but it is still unclear which underlying mechanism causes this stress-reduction. A potential explanation lies in the theories by Kaplan (S. Kaplan, 1987) and Ulrich (R. S. Ulrich, 1983), which state that people have a tendency to prefer natural settings to built environments. Although these two theories have some important differences (see Hartig et al. (1996) for a discussion), both are based on the same evolutionary assumptions. The preferences for natural settings are assumed to have an evolutionary base; people are to some extent biologically adapted to natural as opposed to built environments. Secondly, it might be argued that nature may be processed more easily and efficiently because the brain and sensory systems evolved in natural environments (Wohlwill, 1983). As a result, humans have an innate tendency to pay attention and respond positively to natural elements (Ulrich et al., 1991). This predisposition to prefer natural elements to man-made objects may be the explanation of the stress-reducing effects of nature. It might thus be hypothesized that natural elements affect feelings of stress through the perceived attractiveness of an environment. In a laboratory experiment, Dijkstra et al. (Dijkstra, Pieterse, \& Pruyn, 2008) tested this hypothesis and demonstrated the stress-reducing properties of indoor plants in a simulated hospital room. Moreover, this effect was mediated by the perceived attractiveness of the hospital room. The presence of indoor plants in a hospital resulted in participants perceiving the room as more attractive, which in turn resulted in less perceived stress. Considering the potential infection risks of real plants, Dijkstra (Dijkstra, 2009) conducted a second experiment in a figurative painting of a tree was added to a patient room. This second experiment re-confirmed the stress-reducing properties of nature, and replicated the mediating effect of perceived attractiveness on stress. Furthermore, stress is not only reduced by indoor plants, but by a painting of nature as well. An association task revealed that, next to indoor plants, a painting of a tree also activated the concept of nature. This suggests that a mere association with nature could potentially lead to beneficial effects. Taken together, nature interventions have shown to be beneficial in a variety of settings. This includes both real and simulated nature interventions. Applying such nature interventions in the CT scan suite might thus lead to beneficial effects in patients.
- OBJECTIVES
This research project aims to gain insight in how the physical environment of the CT scan suite affects patients' health and well-being. Patients undergoing procedures in a CT scan suite are often anxious and frightened. Stress reactions can be considered a clinical problem since they often result in negative or worsened medical outcomes. Reduction in state anxiety may help to promote relaxation, which in turn is beneficial for a patient's sense of well-being.
Primary Objective: to determine whether a skyceiling lowers stress and anxiety during diagnostic procedures in a CT scan suite.
Secondary Objective(s): to determine whether a skyceiling improves environmental appraisals, mood, satisfaction with the provided service, time perception, and trust in the healthcare provider.
- Keywords
- Stress, Anxiety, Skyceiling, Nature
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SkyCeiling during CT-Suite visit | Patients in the trial group are exposed to the SkyCeiling during their procedure. | |
| No SkyCeiling during CT-Suite visit | Patients in the trial group are not exposed to the SkyCeiling during their procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress and anxiety measured with questionnaires and physiological parameters
Measured: 30 minutes During CT-scan visit
Secondary outcomes (1)
environmental appraisals, mood, satisfaction with the provided service, time perception, and trust in the healthcare provider.
Measured: 30 minutes during CT-scan visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Twente
- Responsible party
- Principal investigator, Trialbureau radiology, Erasmus Medical Center
- Investigators
- Karin Tanja-Dijkstra, docter, Principal investigator, University of TwenteBerend Koudstaal, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01667705
- Sponsor's protocol ID
- EMCSkyceiling01032012
- Acronym
- Skyceiling
- Status last verified
- Nov 2016
- First submitted
- 1 Mar 2012
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Experience in the CT Scan Suite
- ClinicalTrials.gov ID
- NCT01667705
- Acronym / sponsor ID
- Skyceiling / EMCSkyceiling01032012
- Keywords
- Stress, Anxiety, Skyceiling, Nature
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Technical University of Twente
- Study start
- Mar 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Aug 2012 (estimated)
- 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.
- Rationale: Recently, research that demonstrates a clear relationship between the built healthcare environment and the health and wellbeing of patients has come available. Patients in a CT scan suite are usually anxious. The environment has been shown to lower stress; a painting or piece of art for example, can capture and hold attention and thereby lower negative thoughts and evoke positive emotions. Sights of nature have demonstrated to be especially effective in recuperating from stress, presumably because the human brain has evolved in a natural environment. The current study will investigate the effects of exposure to nature in the CT scan suite. A SkyCeiling, a large, slightly illuminated, photographic illusion of a real sky view is placed above the CT scan. The main hypothesis of this study is that a sky view will lead to a lower level of anxiety in the CT scan suite.
- Objective: The primary objective of this study is to examine the effect of a view of nature on a patient's stress and anxiety. Secondary objectives are to study the effects of a view of nature on a patient's environmental appraisals of the CT suite, satisfaction with the provided service, and trust in the healthcare provider.
Detailed description
- INTRODUCTION AND RATIONALE The importance and the potential benefits of well-designed healthcare facilities have been widely acknowledged and recent research clearly demonstrates the relationship between the built healthcare environment and patients' health and well-being (Dijkstra, 2009). Encounters with healthcare situations are generally characterized by fear, anxiety, stress, and uncertainty (Mitchell, 2003; Pearson, Maddern, \& Fitridge, 2005). Looking at most environments in which these encounters take place, one might rightfully ask how well these healthcare environments satisfy the psychological needs of patients. In order to create more beneficial environments, environmental stimuli can be added to (or removed from) the environment to influence the patient in a positive manner. The environment may elicit positive feelings, hold attention and interest, and block or reduce negative thoughts, for example, by the presence of art or a view from a window (R. S. Ulrich, 1984). The purpose of the present study is to improve patients' well-being by adding positive elements to existing healthcare environments, such as pictures of nature. Stress is an important factor in healthcare situations and stress reactions can be considered a clinical problem since they often result in negative or worsened medical outcomes (Malkin, 2008). Previous studies (Volicer \& Volicer, 1978), for example, found that hospital stress was correlated with changes in heart rate and blood pressure. Other studies showed that psychological stress impairs wound healing in patients (Christian, Graham, Padgett, Glaser, \& Kiecolt-Glaser, 2006; Kiecolt-Glaser, Marucha, Malarkey, Mercado, \& Glaser, 1995). Elbrecht and colleagues (Elbrecht et al., 2004) studied the effects of perceived stress and cortisol levels on wound healing and demonstrated a considerable negative effect of stress. Rabin (2004 in Malkin 2008; personal communication 2008) proposed that pleasant healthcare environments are those that are perceived by the brain as calming, meaning that the stress reactive areas of the brain decrease their activity with a resultant decrease in the concentration of cortisol and norepinephrine in the blood. This results in patients experiencing less pain, having more restful sleep, less anger, less muscle tension, and a lower risk of stroke. Furthermore, Kaplan and Kaplan (R. Kaplan \& Kaplan, 1989) state that "the nervous system seems to be structured in such a way that pleasure and pain tend to inhibit each other". A more pleasant healthcare environment could, therefore, result in less stress and anxiety in patients and this should lead to better health and increased feelings of well-being. When speaking about a more pleasant healthcare environment, a wide variety of environmental characteristics come to mind. Variables such as indoor plants and music could help create environments that generate positive feelings and, as a consequence, reduce negative outcomes. Nonpharmacological anti-anxiety interventions The advantage of using environmental interventions to lower anxiety is that these kind of interventions do not carry any risk and are not time consuming. Several studies have examined various methods of anxiety reduction in healthcare environments. For example, research has demonstrated the beneficial effects of scents on anxiety and mood in dental patients (Lehrner, Eckersberger, Walla, Poetsch, \& Deecke, 2000; Lehrner, Marwinski, Lehr, Johren, \& Deecke, 2005) Furthermore, music therapy has successfully been applied to reduce pain and anxiety in patients undergoing various medical procedures, such as children with cancer undergoing lumbar puncture (Thanh Nhan, Nilsson, Hellström, \& Bengtson, 2010) and women during caesarian delivery (Chang \& Chen, 2005). Sunlight appeared to have beneficial effects on perceived stress (Walch et al., 2005). A recent study (Park \& Mattson, 2009) demonstrated that indoor plants in a hospital room can have therapeutic value and serve as a noninvasive and effective complementary medicine for surgical patients. Esthetic enhancements can thus provide unobtrusive and inexpensive stress and anxiety management methods. In this study we propose nature as an anti-anxiety intervention, which possibly has an even stronger effect on anxiety then scent, daylight or music. Nature interventions Research on restorative environments suggests that certain environments are capable of promoting recovery from stress. Especially natural settings have these restorative effects (Hartig, Book, Garvill, Olsson, \& Garling, 1996). Considering the potential healing properties of nature (Lohr \& Pearson-Mims, 2000; R. S. Ulrich, 1984), exposing patients to natural elements may be an effective way of reducing stress. A recent review concluded that viewing nature scenes may decrease pain perceptions by eliciting positive emotional responses and decreasing stress (Malenbaum, Keefe, Williams, Ulrich, \& Somers, 2008). Ulrich et al. (R. Ulrich et al., 1991) studied the effects of exposure to nature on stress recovery. Participants watched a videotape that induced feelings of stress, and were afterwards exposed to a tape with either a natural or an urban environment. Results demonstrated that individuals recover sooner from stress when exposed to the former (natural) than the latter (urban). Lohr and Pearson-Mims (2000) studied whether the presence of indoor plants would increase pain tolerance. Participants were either placed in a room with plants, a room with non-plant objects (as visually distractive as the plants), or a control room (no objects). Results showed that a significantly larger proportion of respondents in the room with plants were able to keep their hand in the ice water for 5 minutes as compared to the other conditions, suggesting increased pain tolerance by exposure to indoor plants. They also showed that the room with plants was rated more positively (e.g., cheerful, calming, pleasant) than either of the control rooms. The results of these studies support the idea that nature may have beneficial effects on the health and well-being of people. Natural elements in the built environment have clearly shown stress-reducing properties, but it is still unclear which underlying mechanism causes this stress-reduction. A potential explanation lies in the theories by Kaplan (S. Kaplan, 1987) and Ulrich (R. S. Ulrich, 1983), which state that people have a tendency to prefer natural settings to built environments. Although these two theories have some important differences (see Hartig et al. (1996) for a discussion), both are based on the same evolutionary assumptions. The preferences for natural settings are assumed to have an evolutionary base; people are to some extent biologically adapted to natural as opposed to built environments. Secondly, it might be argued that nature may be processed more easily and efficiently because the brain and sensory systems evolved in natural environments (Wohlwill, 1983). As a result, humans have an innate tendency to pay attention and respond positively to natural elements (Ulrich et al., 1991). This predisposition to prefer natural elements to man-made objects may be the explanation of the stress-reducing effects of nature. It might thus be hypothesized that natural elements affect feelings of stress through the perceived attractiveness of an environment. In a laboratory experiment, Dijkstra et al. (Dijkstra, Pieterse, \& Pruyn, 2008) tested this hypothesis and demonstrated the stress-reducing properties of indoor plants in a simulated hospital room. Moreover, this effect was mediated by the perceived attractiveness of the hospital room. The presence of indoor plants in a hospital resulted in participants perceiving the room as more attractive, which in turn resulted in less perceived stress. Considering the potential infection risks of real plants, Dijkstra (Dijkstra, 2009) conducted a second experiment in a figurative painting of a tree was added to a patient room. This second experiment re-confirmed the stress-reducing properties of nature, and replicated the mediating effect of perceived attractiveness on stress. Furthermore, stress is not only reduced by indoor plants, but by a painting of nature as well. An association task revealed that, next to indoor plants, a painting of a tree also activated the concept of nature. This suggests that a mere association with nature could potentially lead to beneficial effects. Taken together, nature interventions have shown to be beneficial in a variety of settings. This includes both real and simulated nature interventions. Applying such nature interventions in the CT scan suite might thus lead to beneficial effects in patients.
- OBJECTIVES
This research project aims to gain insight in how the physical environment of the CT scan suite affects patients' health and well-being. Patients undergoing procedures in a CT scan suite are often anxious and frightened. Stress reactions can be considered a clinical problem since they often result in negative or worsened medical outcomes. Reduction in state anxiety may help to promote relaxation, which in turn is beneficial for a patient's sense of well-being.
Primary Objective: to determine whether a skyceiling lowers stress and anxiety during diagnostic procedures in a CT scan suite.
Secondary Objective(s): to determine whether a skyceiling improves environmental appraisals, mood, satisfaction with the provided service, time perception, and trust in the healthcare provider.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SkyCeiling during CT-Suite visit | – | –Patients in the trial group are exposed to the SkyCeiling during their procedure. |
| No SkyCeiling during CT-Suite visit | – | –Patients in the trial group are not exposed to the SkyCeiling during their procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 Out-patients, age 18-85, who are scheduled to undergo a thorax and/or abdomen CT scan with intravenous contrast.
Key inclusion criteria (3 listed)
- Age 18-85
- Able to read and write Dutch
- Able to observe the visual stimuli applied to the ceiling, i.e. normal vision or corrected to normal vision.
Key exclusion criteria (3 listed)
- Patients who have undergone a CT scan after the SkyCeiling was installed (this is a rare event) are excluded. This because of the fact that these patients might remember the look of the CT unit either with or without the SkyCeiling and could thus become more aware of the intended anxiety-reducing effect of the intervention, or the lack thereof if randomized to the control group.
- Patients who undergo a second scan during the run time of this study (this will be a rare event) will not be included a second time. The data of their first scan remain included.
- Patients who lie with their face down or are otherwise incapable of looking at the ceiling will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
stress and anxiety measured with questionnaires and physiological parameters
Time frame: 30 minutes During CT-scan visit
1 secondary outcome
environmental appraisals, mood, satisfaction with the provided service, time perception, and trust in the healthcare provider.
Time frame: 30 minutes during CT-scan visit
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 30 Nov 2016.
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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.
Karin Tanja-Dijkstra, docter principal investigator
University of Twente
Berend Koudstaal study chair
Erasmus Medical Center
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 Stress and Anxiety, run by Erasmus Medical Center at 1 site in Netherlands.
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 3 inclusion and 3 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 30 Nov 2016. 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 Netherlands. 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?
stress and anxiety measured with questionnaires and physiological parameters (time frame: 30 minutes During CT-scan visit). 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 30 Nov 2016.