To Examine the Effect of a View of Nature on Patient's Stress and Anxiety (Skyceiling)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by Erasmus Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Technical University of Twente
Information provided by (Responsible Party):
Trialbureau radiology, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01667705
First received: March 1, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose
  • 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.

Condition
Stress
Anxiety

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Patient Experience in the CT Scan Suite

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • stress and anxiety measured with questionnaires and physiological parameters [ Time Frame: 30 minutes During CT-scan visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • environmental appraisals, mood, satisfaction with the provided service, time perception, and trust in the healthcare provider. [ Time Frame: 30 minutes during CT-scan visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

120 Out-patients, age 18-85, who are scheduled to undergo a thorax and/or abdomen CT scan with intravenous contrast.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01667705

Contacts
Contact: Berend Koudstaal 31 10 7034044 b.koudstaal@erasmusmc.nl

Locations
Netherlands
ErasmusMC Recruiting
Rotterdam, Zuid Holland, Netherlands, 3015CE
Contact: Berend Koudstaal       b.koudstaal@erasmusmc.nl   
Principal Investigator: Berend Koudstaal         
Principal Investigator: Karin Tanja Dijkstra, dr         
Sponsors and Collaborators
Erasmus Medical Center
Technical University of Twente
Investigators
Principal Investigator: Karin Tanja-Dijkstra, docter University of Twente
Study Chair: Berend Koudstaal Erasmus Medical Center
  More Information

No publications provided

Responsible Party: Trialbureau radiology, Coordinating investigator, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01667705     History of Changes
Other Study ID Numbers: EMCSkyceiling01032012
Study First Received: March 1, 2012
Last Updated: August 16, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Erasmus Medical Center:
Stress
Anxiety
Skyceiling
Nature

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 21, 2014