Cancer
Conditions
Keywords
Advanced Cancer, Cancer Patients, Relaxation Therapy, Relaxation and Heart Rate Variability, Guided Relaxation, HRV, Stress, Anxiety, and Panic Disorder
Brief 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.
Detailed 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.
Interventions
OTHERGuided 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.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Written informed consent 2. Normal cognition (per treating physician's assessment)
Exclusion criteria
1. Dementia 2. Psychosis 3. Delirium 4. Not fluent in English 5. Cardiac dysrhythmia 6. Inability to lay supine 7. Pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences Between Pre/Post ESAS Score | Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time) | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: 7/09/2008 through 7/10/2008. All participants recruited at University of Texas MD Anderson Cancer Center.
Pre-assignment details
One of twenty enrolled participants did not meet eligibility criteria and was excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Guided Relaxation Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Guided Relaxation |
|---|---|
| Age Continuous | 57 Years |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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.
Time frame: Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)
Population: Analysis included all study participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Guided Relaxation | Differences Between Pre/Post ESAS Score | -9.1 units on a scale | Standard Deviation 2.4 |