UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052413 |
|---|---|
| Receipt number | R000059829 |
| Scientific Title | Can measurement of heart rate variability be a quantitative assessment of pain in cognitively impaired pain patients? |
| Date of disclosure of the study information | 2025/03/15 |
| Last modified on | 2023/10/04 21:20:12 |
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Basic information
Public title
Can measurement of heart rate variability be a quantitative assessment of pain in cognitively impaired pain patients?
Acronym
Can measurement of heart rate variability be a quantitative assessment of pain in cognitively impaired pain patients?
Scientific Title
Can measurement of heart rate variability be a quantitative assessment of pain in cognitively impaired pain patients?
Scientific Title:Acronym
Can measurement of heart rate variability be a quantitative assessment of pain in cognitively impaired pain patients?
Region
| Japan |
Condition
Condition
Pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Does daily measurement of heart rate variability lead to changes in autonomic status as well as changes in pain status? In addition, the purpose of this study is to clarify whether the autonomic status of patients with cognitive decline allows for the assessment of pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inpatients in the normal cognitive function group and the cognitively impaired group will be asked to verbally answer the Numerical Rating Scale daily. A heart rate variability measurement device will be placed on the bilateral forearms. Resting sitting position will be performed for 10 minutes, and the ECG will be recorded for the latter 5 minutes. The detected RR waveforms will be analyzed in the time domain and frequency domain. In the time domain analysis, RR intervals , SDNN , NN50 , and pNN50 are used as parameters. In the frequency analysis, the spectral power densities of the different component frequencies of HR are obtained by Fast Fourier Transform. The power spectrum is divided into three frequency bands: VLF 0.001-0.04 Hz, LF 0.040-0.15 Hz, and HF 0.15-0.4 Hz. low frequency , high frequency, and LF/HF ratio are calculated from software. These will be measured for 30 days to see if HRV correlates with pain status.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
20 to 100 years old
Key exclusion criteria
Diabetes mellitus
Depression
Persons taking antidepressants, beta-blockers, Ca antagonists, antiepileptic drugs, etc.
Hypothyroidism, hyperthyroidism
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | RYOTA |
| Middle name | |
| Last name | OSUMI |
Organization
Narahigashi Hospital
Division name
Department of Rehabilitation
Zip code
632-0001
Address
470 Nakanosho-machi, Tenri City, Nara Prefecture
TEL
0743615543
crazy_monkeys_no11@yahoo.co.jp
Public contact
Name of contact person
| 1st name | RYOTA |
| Middle name | |
| Last name | OSUMI |
Organization
Narahigashi Hospital
Division name
Department of Rehabilitation
Zip code
632-0001
Address
470 Nakanosho-machi, Tenri City, Nara Prefecture
TEL
0743615543
Homepage URL
crazy_monkeys_no11@yahoo.co.jp
Sponsor or person
Institute
Narahigashi Hospital
Department of Rehabilitation
Osumi Ryota
Institute
Department
Personal name
Funding Source
Organization
without
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio uniersity
Address
4-2-2, Umaminaka, Kouryo-cho, Kitakaturagi-gun, Nara, Japan
Tel
+819069137737
crazy_monkeys_no11@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
longitudinal study
Management information
Registered date
| 2023 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059829
