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Efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis.

Efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis, multicenter prospective observational study. - Efficacy of heart rate variability in objective evaluation for the pain caused by bone metastasis, multicenter prospective observational study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000044203
Enrollment
100
Registered
2021-07-01
Start date
2021-07-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone metastasis

Interventions

None listed

Sponsors

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with severe pain of NRS4 or more 2. Patients aged 20 years or over when acquiring informed consent 3. No metastatic bone tumors other than in radiation field that could cause severe pain 4. Patients with expected prognosis of 3 months or more 5. Patients with ability to assess pain, anxiety and depression by themselves 6. Patients received sufficient explanation before participating in this study, and obtained written consent by the patient himself / herself with sufficient understanding

Exclusion criteria

Exclusion criteria: 1. Patients whose RR interval cannot be accurately evaluated due to arrhythmia 2. Patients with psychiatric complications such as depression and anxiety disorders 3. Patients with apparently poor cognitive function 4. Metastatic bone tumors with fracture or strong nerve invasion (patients who are difficult to obtain the pain-relieving effect by radiation) 5. Patients with retinopathy, nephropathy or neuropathy caused by diabetes 6. Patients who are not expected to be outpatients at one month after radiation

Design outcomes

Primary

MeasureTime frame
Correlation between autonomic nerve activity (LF/HF, HF and total power) evaluated by heart rate variability and pain assessment

Countries

Japan

Contacts

Public ContactKeiko Murofushi

Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital Radiation Oncology

kmurofushi0918@gmail.com03-3823-2101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026