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Heart rate variability as a measure of pain intensity in patients with cancer-related pain.


- candidate number2008
- NTR NumberNTR656
- ISRCTNIncomplete info for ISRCTN
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-mrt-2006
- Secondary IDsN/A 
- Public TitleHeart rate variability as a measure of pain intensity in patients with cancer-related pain.
- Scientific TitleHeart rate variability as a measure of pain intensity in patients with cancer-related pain.
- ACRONYMN/A
- hypothesisHeart rate variability measures correlate with pain intensity in patients with advanced cancer.
- Healt Condition(s) or Problem(s) studiedMalignancy
- Inclusion criteria1. Patients with known metastatic malignancy;
2. Patients with a pain intensity of at least 5 on a visual analogue pain scale;
3. Patients able to have heart rate measures taken;
4. Patients able to fill in the EORTC QLQ-C30;
5. Patients should have sinus rhythm;
6. Performance score 0, 1 or 2;
7. Informed consent should be given.
- Exclusion criteria1. Patients with neuropathic pain;
2. Patients using medication that interferes with HRV;
3. Patients who have hemodynamically significant cardiac valvular abnormalities, severe chronic heart failure (NYHA III-IV), a history of vagotomy or sympathectomy;
4. Patients with other conditions / illnesses that can influence autonomic function;
5. Patients with brain metastases;
6. Patients who are treated with chemotherapy;
7. Patients who will start with chemotherapy and/or radiotherapy within the week of the study.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate30-apr-2008
- Target number of participants30
- InterventionsHeart rate variability measurements will be performed on day 0 (before start of pain medication), day 2 and day 7.
- Primary outcomeCorrelation between the pain intensity as measured by the visual analogue scale and as measured by heart rate variability.
- Secondary outcome1. Correlation between the response to pain medication using the visual analogue scale and the EORTC QLQ-C30 questionnairel;
2. correlation between the response to pain medication using heart rate variability measures and the EORTC QLQ-C30 questionnaire.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A. Reyners
- CONTACT for SCIENTIFIC QUERIES A. Reyners
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-mrt-2006 - 22-jan-2011


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