UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035465 |
|---|---|
| Receipt number | R000040403 |
| Scientific Title | Relationship between mild pain change and heart rate variability, biofeedback in cancer patients |
| Date of disclosure of the study information | 2019/01/06 |
| Last modified on | 2019/01/06 21:25:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Relationship between mild pain change and heart rate variability, biofeedback in cancer patients
Acronym
Mild pain change and heart rate variability, biofeedback
Scientific Title
Relationship between mild pain change and heart rate variability, biofeedback in cancer patients
Scientific Title:Acronym
Mild pain change and heart rate variability, biofeedback
Region
| Japan |
Condition
Condition
Cancer pain
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the effect of mild pain change on heart rate variability and the effect of HRV biofeedback on mild pain change.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change amount of HRV before and after change in pain NRS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Interventions group:
Heart rate variability biofeedback(5 miniuts)
Interventions/Control_2
Control group:
sham(5 miniuts)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Hospitalized cancer patients with complaints of pain
2.Pain NRS is below personalized pain goal
Key exclusion criteria
1.Patients who changed analgesic and analgescic adjuvant agents within 2 days
2.Patients who used rescue analgesic within 2 days
3.Uncontrolled psychiatric disease
Target sample size
108
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
hasuohid@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
hasuohid@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Katano foundation grant
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2019 | Year | 01 | Month | 06 | 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
| 2019 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 06 | Day |
Last modified on
| 2019 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040403
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
