Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT03239587 |
| Other study ID # |
2016-0808 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 24, 2017 |
| Est. completion date |
April 24, 2018 |
Study information
| Verified date |
August 2023 |
| Source |
M.D. Anderson Cancer Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this research study is to learn if simulated live piano music can change the
amount of stress felt in patients with cancer before surgery, health care providers caring
for cancer patients, and/or hospital volunteers.
This is an investigational study.
Up to 304 participants (200 patients, 52 volunteers, and 52 healthcare providers) will be
enrolled in this study. All will take part at MD Anderson.
Description:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 study groups. Participants in the first group will wait for 30 minutes in a
standard pre-surgery waiting area without music. Participants in the other group will go to a
waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano
music.
A Steinway Spirio grand piano is a special type of piano that plays music by itself (also
called a player piano). The music will be chosen by the study staff and pre-recorded on the
piano. Although the keys will move on the piano as if someone is playing the piano, you will
be alone in the room.
You will have an equal chance (50/50) of being assigned to either group. Both you and the
person in charge of this study will know to which group you have been assigned. You do not
get to choose which group you are in.
Study Procedures:
Before and about 30 minutes after you either listen to music or stand in the waiting room
without music:
- Blood (about 1½ teaspoons each time) will be drawn to learn how your body is responding
to the music or silence by measuring the amount of cortisol in your body (a type of
hormone related to stress) and for biomarker testing. Biomarkers are found in the blood
and may be related to your reaction to the music or silence. If you are a healthcare
provider or volunteer, you will not have these blood draws.
- You will complete 2 questionnaires about your anxiety and stress levels. It should take
about 20-30 minutes to complete.
Length of Study:
You participation on this study will be over after the last blood draw and questionnaire are
completed.
