Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2008-06-30
2008-09-30
Brief Summary
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* 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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Guided Relaxation
Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Normal cognition (per treating physician's assessment)
Exclusion Criteria
2. Psychosis
3. Delirium
4. Not fluent in English
5. Cardiac dysrhythmia
6. Inability to lay supine
7. Pacemaker
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ying Guo, MD
Role: PRINCIPAL_INVESTIGATOR
U.T. M.D. Anderson Cancer Center Professor
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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U.T. M.D. Anderson Cancer Center
Other Identifiers
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2008-0028
Identifier Type: -
Identifier Source: org_study_id