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An Evaluation of the Effect of 'Open Window' on Psychological Well-being and Experience of Stem Cell Transplantation

NCT00348959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2012-06-13

No results posted yet for this study

Summary

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.

Results:

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Irish Cancer Society

    collaborator OTHER

  • St. James's Hospital, Ireland

    lead OTHER

Principal Investigators

  • Shaun McCann · St. James's Hospital, Ireland

  • Catherine McCabe, BNS, MSc · University of Dublin, Trinity College

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2010-01-31
Completion
2010-01-31

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00348959 on ClinicalTrials.gov