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| Sponsored by: |
M.D. Anderson Cancer Center |
|---|---|
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00735618 |
Purpose
Primary:
Secondary:
| Condition | Intervention |
|---|---|
|
Cancer |
Other: Guided Relaxation Other: HRV HF spectral analysis |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Single Group Assignment |
| Official Title: | Pilot Study on the Effects of a Brief Relaxation Program on Heart Rate Variability in Cancer Patients |
| Estimated Enrollment: | 20 |
| Study Start Date: | June 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Individuals who have cancer now or had cancer in the past
|
Other: Guided Relaxation
Following 5 minute questionnaire, 15 minute rest and 5 minute heart rhythm recording, 15 minute relaxation program (listening via headphone to audio recording) to be completed by second heart rhythm recording and same questionnaire. Entire procedure 45-60 minutes.
Other: HRV HF spectral analysis
Heart Rate Variability (HRV) High frequency (HF) spectral analysis: Following 15 minute rest, 5 minute HRV recording (HF spectral analysis) electrodes placed along chest (same way as electrocardiogram). Procedure repeated after relaxation program for second 5 minute recording. |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| U. T. M.D. Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Ying Guo, MD | U.T. M.D. Anderson Cancer Center Professor |
More Information
| Responsible Party: | U.T. M. D. Anderson Cancer Center ( Ying Guo, MD, MS, Assistant Professor ) |
| Study ID Numbers: | 2008-0028 |
| Study First Received: | August 12, 2008 |
| Last Updated: | October 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00735618 |
| Health Authority: | United States: Institutional Review Board |
|
Advanced Cancer Cancer Patients Relaxation Therapy Relaxation and Heart Rate Variability |
Guided Relaxation HRV Stress, Anxiety, and Panic Disorder |
|
Panic Disorder Stress |
