Cancer Clinical Trial - Relaxation & Heart Rate Variability

Status Completed

Clinical Trial Summary

Primary:

- To characterize the physiologic changes of the autonomic nervous system, demonstrated by heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program for cancer patients.

Secondary:

- To assess whether change of HRV correlates with subjective feeling for anxiety, based on visual analog scale scores.

Clinical Trial Description

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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT00735618
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Completed
Phase	N/A
Start date	June 2008
Completion date	September 2008

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Relaxation and Heart Rate Variability

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms