No registrations found.
ID
Source
Brief title
Health condition
Patients with malignancy visiting our outpatient clinic who have a pain intensity of at least 5 on a visual analogue scale (ranging from 0-10) can be included.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Correlation between the pain intensity as measured by the visual analogue scale and as measured by heart rate variability.
Secondary outcome
1. 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.
Background summary
N/A
Study objective
Heart rate variability measures correlate with pain intensity in patients with advanced cancer.
Study design
N/A
Intervention
Heart rate variability measurements will be performed on day 0 (before start of pain medication), day 2 and day 7.
[default]
The Netherlands
[default]
The Netherlands
Inclusion criteria
1. 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 criteria
1. 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL600 |
| NTR-old | NTR656 |
| Other | : N/A |
| ISRCTN | Incomplete info for ISRCTN |