An Evaluation of the Effect of 'Open Window' on Psychological Well-being and Experience of Stem Cell Transplantation
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|ClinicalTrials.gov Identifier: NCT00348959|
Recruitment Status : Completed
First Posted : July 6, 2006
Last Update Posted : June 13, 2012
The 'Open Window' Study is a prospective longitudinal study using a 4 group randomised control trial design to evaluate the psychological effect of 'Open Window' on the consequences of long term isolation on patients undergoing stem cell transplantation treatment of haematological malignancies. This study uses a randomised control trial design, which is widely used in healthcare settings to test the effects of interventions and testing cause and effect relationships between variables. A mixed methods approach for data collection and data analysis is being used. This will facilitate measurement of patients' psychological response to 'Open Window' using questionnaires and exploration of subjective feelings in relation to personal experiences of having a stem cell transplant through semi structured interviews.
Hypothesis to be tested
'Open Window' has no effect on patients' levels of anxiety, depression, or distress when undergoing a stem cell transplant.
Of the 199 patients in the study, 96 were randomized to the intervention group and 103 to the control group. Participants in the intervention group had significantly reduced levels of anxiety on the day before transplant (P = 0.001), at day 7 (P = 0.041), and day 60 (P = 0.035). There was a significant reduction in depression before transplant (P= 0.022). Participants in the intervention group reported better experiences (P < 0.005).
|Condition or disease||Intervention/treatment||Phase|
|Hematological Malignancies||Behavioral: 'Open Window' Project||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||An Evaluation of the Effect of 'Open Window', an Art Intervention, on Psychological Well-being and Experience of Stem Cell Transplantation for the Treatment of Haematological Malignancies|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
Behavioral: 'Open Window' Project
Open Window' is an entirely art based intervention comprising a multimedia system that uses a combination of video projectors, audio speakers and bespoke software to make images appear as a 'virtual window' on the wall of the patients' room. Artists use mobile phone cameras and camcorders to record the images that are sent to the unit over the internet and via mobile phone networks. Original music composed for the project may also accompany the images as they appear.
Artists are commissioned to create work for the 'Open Window' project and are aware of the nature of the viewer and the context in which the art will be shown. The art in 'Open Window' encourages the viewer to think about and engage in what they see from their own personal frame of reference.
- The primary outcome measures are Anxiety, Depression and Distress. Measures will be taken on 7 occasions over a six month period. [ Time Frame: Six Months ]
- Patient expectations in relation to the experience of having a stem cell transplant. [ Time Frame: Day + 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348959
|St. James's Hospital|
|Dublin, Ireland, 8|
|Study Director:||Shaun McCann||St. James's Hospital, Ireland|
|Principal Investigator:||Catherine McCabe, BNS, MSc||Trinity College Dublin|