N/A
N=19
Relaxation and Heart Rate Variability
Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00735618 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Dec 2011
Primary outcome: Primary: Differences Between Pre/Post ESAS Score — -9.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Guided Relaxation (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Differences Between Pre/Post ESAS Score |
-9.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00735618). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.