What is the purpose of this research study?
The purpose of this study is to find out if patients who are in the ICU and using a ventilator will benefit from listening to music. Patients on a ventilator in the ICU often experience feelings of confusion which is called delirium. Patients may also experience pain and feelings of anxiety. We will test to see if music will:
- lessen this confusion.
- lessen pain and anxiety.
Who can participate in this study?
You may be eligible to participate if:
- you are age 50 or older.
- you speak English.
- you are using a mechanical ventilator (respirator) to support your breathing.
What will happen if I participate in this study?
You will be assigned by chance (like a coin toss) to one of two groups:
- You listen to music from a library ofmusic provided to you. OR
- You will listen to a “silence track” that blocks out noise from your hospital room.
You will wear headphones for one-hour sessions twice a day for up to 7 days. A member of the study team will visit you up to 4 times a day to ask you simple questions about feelings, thinking, and memory. These visits will occur only while you are in the ICU, for up to 28 days. A blood collection will be completed 3 times, totaling about 2 tablespoons:
1. Upon enrollment and before your first music or silence track session
2. On day 3 of receiving the music or silence track sessions
3. After the last music or silence track session
About 3 months after you leave the hospital, a member of the study team will call you to ask you follow up questions.
Will my information be kept private?
Eskenazi Health and Indiana University Health are committed in keeping your personal information confidential.
Are there any risks involved?
• During the assessments you may experience fatigue, anxiety, stress, or embarrassment.
• The headphones may feel uncomfortable or cause irritation.
• The music may cause an undesired emotion.
• Your confidential information may be seen by those who are not authorized.
Will I get any benefit from being in the study?
While there are no guarantees of a benefit, based on prior research studies, we feel that participation in this project will provide you a new experience and the music may decrease your level of anxiety in the intensive care unit. Future patients of the ICU may benefit from what we learn in this research study.
Do I have to participate in this study?
You do not have to participate. If you decide to join, you can stop at any time. You should only participate if you want to do so. Your care at Eskenazi health or Indiana University Health will not be affected if you choose not to participate.
Who can I contact for more information?
For more information, contact a member of the research study team at 317-274-9427 or email
sikhan@iupui.edu
