NCT01667705

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

1.8 years

First QC Date

March 1, 2012

Last Update Submit

November 29, 2016

Conditions

Keywords

StressAnxietySkyceilingNature

Outcome Measures

Primary Outcomes (1)

  • stress and anxiety measured with questionnaires and physiological parameters

    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.

    30 minutes during CT-scan visit

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ErasmusMC

Rotterdam, South Holland, 3015CE, Netherlands

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Karin Tanja-Dijkstra, docter

    University of Twente

    PRINCIPAL INVESTIGATOR
  • Berend Koudstaal

    Erasmus Medical Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Coordinating investigator

Study Record Dates

First Submitted

March 1, 2012

First Posted

August 17, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations