Trial Outcomes & Findings for Relaxation and Heart Rate Variability (NCT NCT00735618)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)

Results posted on

2011-12-19

Participant Flow

Recruitment Period: 7/09/2008 through 7/10/2008. All participants recruited at University of Texas MD Anderson Cancer Center.

One of twenty enrolled participants did not meet eligibility criteria and was excluded from the study.

Participant milestones

Participant milestones
Measure	Guided Relaxation Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Relaxation and Heart Rate Variability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guided Relaxation n=19 Participants Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
Age Continuous	57 Years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)

Population: Analysis included all study participants.

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.

Outcome measures

Outcome measures
Measure	Guided Relaxation n=19 Participants Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program and summed ESAS scores
Differences Between Pre/Post ESAS Score	-9.1 units on a scale Standard Deviation 2.4

Adverse Events

Guided Relaxation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ying Guo, MD, MS/Associate Professor

UT MD Anderson Cancer Center

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place