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Clinical Trials/NCT01184534
NCT01184534CompletedNot Applicable

Increasing Patient Preparedness for the Procedural Experience and Improving Qualitative Outcomes Through Patient Education

M.D. Anderson Cancer Center1 site in 1 country50 target enrollmentStarted: August 2010Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
50
Locations
1
Primary Endpoint
Patient Response to Subjective Anxiety Surveys

Study Overview

Brief Summary

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.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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