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OpenTrials
Completed

NCT Number: NCT01184534

Multimedia 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Video

Behavioral

5 minute multimedia presentation (video)

Questionnaires

Behavioral

2 questionnaires pre and post procedure taking approximately 15 minutes each to complete.

Other names: Survey

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 19, 2010
Registry last updated
Feb 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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