- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01184534
Multimedia Patient Education
Increasing Patient Preparedness for the Procedural Experience and Improving Qualitative Outcomes Through Patient Education
Objective:
To compare changes in patient anxiety levels between groups of patients who either were or were not exposed to an informative multimedia patient education tool, in order to determine how the addition of such a multimedia tool will affect this parameter. Specifically, the study will focus on subjective anxiety as measured on pre procedure and post procedure patient surveys as detailed under study components.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
If you agree to take part in this study, you will complete a questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.
After you have completed the questionnaire, you will be randomly assigned (as in the flip of a coin) to Group 1 or Group 2. You will have an equal chance of being in either group.
If you are in Group 1, you will receive routine information before the lung biopsy and you will watch a video on a handheld or laptop machine with headphones. The video is designed to help you understand the biopsy procedure. This video should last about 5 minutes. You will then complete a questionnaire that asks how you feel after watching the video. It will take about 5 minutes to complete.
If you are in Group 2, you will receive routine information before the lung biopsy. You will then complete another questionnaire that asks how you feel before the procedure. It will take about 5 minutes to complete.
After your routine lung biopsy, both groups will complete a questionnaire that asks how you feel after the procedure. It will take about 5 minutes to complete.
For Group 1, the total time to complete the questionnaires and watch the video will be 20 minutes.
For Group 2, the total time to complete the questionnaires will be 15 minutes.
Length of Study:
Your participation in this study will be over once you complete the questionnaire after your lung biopsy.
This is an investigational study.
Up to 100 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- UT MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Scheduled for a computed tomography (CT) guided lung biopsy
- Literate English-speaking
Exclusion Criteria:
- Refusal to participate
- Current diagnosis of psychosis, dementia or other mentally altered state.
- Monitored anesthesia care (MAC) or general endotracheal anesthesia (GETA) during the procedure.
- Patients who are clinically diagnosed as hearing and visually impaired.
- Patients who have had prior image guided biopsies in our department.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Questionnaires + Video
|
5 minute multimedia presentation (video)
|
|
Questionnaires
|
2 questionnaires pre and post procedure taking approximately 15 minutes each to complete.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Response to Subjective Anxiety Surveys
Time Frame: 1 day (pre and post lung biopsy procedure)
|
Subjective anxiety as measured on pre procedure and post procedure patient surveys.
|
1 day (pre and post lung biopsy procedure)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stephen McRae, MD, UT MD Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2010-0397
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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