Pilot Study on the Effects of a Brief Relaxation Program on Heart Rate Variability in Cancer Patients
Rhythm changes in your heart rate are part of the "autonomic" nervous system. This is the
part of your nervous system that controls the body functions that you do not have to think
about. Researchers want to find out if a "guided relaxation" session will make your heart
rate more variable, with more rhythm changes.
If you are found to be eligible to take part in this study, you will first answer a brief
questionnaire that will measure several symptoms, such as pain and anxiety (worry). This
questionnaire will take less than 5 minutes. You will also be asked questions about your
alcohol and smoking history, and if you have ever used relaxation or meditation techniques
in the past. This will also take less than 5 minutes.
You will then be asked to lay on your back, on a hospital bed or exam table. Electrodes
will be placed along your chest, the same way they are placed for an electrocardiogram
(ECG--a test to measure the electrical activity of the heart). You will be asked to rest
for 15 minutes, and then your heart rhythm will be recorded for 5 minutes. After this first
recording, you will begin the relaxation program by listening to an audio recording for
about 15 minutes, using headphones. After the relaxation program has ended, your heart
rhythm will be recorded for another 5-minute period while you are resting.
You will then be asked to complete the same questionnaire as before.
The entire procedure will take about 45-60 minutes. After this second questionnaire, your
participation on this study will be over.
This is an investigational study. Up to 20 people will take part in this study. All will
be enrolled at M. D. Anderson.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Differences Between Pre/Post ESAS Score
Total symptom burden as measured by Edmonton Symptom Assessment Scale (ESAS) in which there are eight visual analog scales (VAS) of 0 to 10, with 10 being most severe. The differences from ESAS baseline (before) to post (after) a 15 minute, one-time, guided relaxation program for each participant assessed, with the average difference in ESAS scores for all participants reported.
Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)
Ying Guo, MD
U.T. M.D. Anderson Cancer Center Professor
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|