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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035465
Receipt No. R000040403
Official scientific title of the study 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

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Basic information
Official scientific title of the study Relationship between mild pain change and heart rate variability, biofeedback in cancer patients
Title of the study (Brief title) 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 Hideaki Hasuo
Organization Kansai Medical University
Division name Department of Psychosomatic Medicine
Address Shinmachi 2-5-1, Hirakata, Osaka
TEL 072-804-0101
Email hasuohid@hirakata.kmu.ac.jp

Public contact
Name of contact person Hideaki Hasuo
Organization Kansai Medical University
Division name Department of Psychosomatic Medicine
Address Shinmachi 2-5-1, Hirakata, Osaka
TEL 072-804-0101
Homepage URL
Email hasuohid@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 02 Month 28 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.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


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