Relaxation and Heart Rate Variability

NCT00735618 | Completed Results

• 1 other identifier: 2008-0028
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Advanced Cancer; Cancer Patients; Relaxation Therapy; Relaxation and Heart Rate Variability; Guided Relaxation; HRV; Stress, Anxiety, and Panic Disorder

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Guided Relaxation

EXPERIMENTAL

Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program

Other: Guided Relaxation

Interventions

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.

Also known as: Relaxation Therapy, Guided Relaxation Program

Guided Relaxation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• U.T. M.D. Anderson Cancer Center

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders; Panic Disorder

Interventions

Relaxation Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Ying Guo, MD, MS/Associate Professor
• Organization: UT MD Anderson Cancer Center

jaallo@mdanderson.org

Study Officials

• Ying Guo, MD

  U.T. M.D. Anderson Cancer Center Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 15, 2008
• Study Start: June 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: December 19, 2011
• Results First Posted: December 19, 2011

Record last verified: 2011-11

Locations

US (1)