Relaxation and Heart Rate Variability

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.

Completed

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Key information

Conditions

Cancer Anxiety Disorders Mental Disorders Neoplasms Panic Disorder

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Written informed consent
Normal cognition (per treating physician's assessment)

Exclusion criteria

Dementia
Psychosis
Delirium
Not fluent in English
Cardiac dysrhythmia
Inability to lay supine
Pacemaker

Treatment and study plan

Guided Relaxation

Other

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 names: Relaxation Therapy, Guided Relaxation Program

Primary outcomes

Differences Between Pre/Post ESAS Score

Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

Pilot Study on the Effects of a Brief Relaxation Program on Heart Rate Variability in Cancer Patients

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Aug 15, 2008
Registry last updated: Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed