Relaxation and Heart Rate Variability

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00735618
• Other study ID #: 2008-0028
• Status: Completed
• Phase: N/A
• First received: August 12, 2008
• Last updated: November 15, 2011
• Start date: June 2008
• Est. completion date: September 2008

Study information

• Verified date: November 2011
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	UT MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)	No

External Links

•   U.T. M.D. Anderson Cancer Center