Clinical trial · Interventional
Relaxation and Heart Rate Variability
Pilot Study on the Effects of a Brief Relaxation Program on Heart Rate Variability in Cancer Patients
NCT00735618CI-TRIAL-00005955completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Guided Relaxation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Guided Relaxation
- description
- Heart rate variability (HRV) high frequency (HF) spectral analysis, before and after a 15 minute, one-time, guided relaxation program
- interventionNames
- Other: Guided Relaxation
Primary outcomes (1)
- measure
- Differences Between Pre/Post ESAS Score
- timeFrame
- Baseline and following completion of HRV recordings and relaxation program (45 - 60 minutes elapsed time)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.