UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of self-healing program of caregiver
Title of the study (Brief title)	Development of self-healing program of caregiver
Region	Japan

Condition
Condition	Stress-related disorders
Classification by specialty	Medicine in general Dermatology Psychiatry Nursing Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The effect of long-term practice of self-healing(centering and grounding)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sense of Coherence(SOC) at the start, after 8 weeks, and after 12 weeks
Key secondary outcomes	Chaos(Lyapunov exponent, entropy) at the start, after 8 weeks, and after 12 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	The intervention is to do self-healing once a day for 12 weeks according to the 7 minutes original voice guidance by media player. This voice guidance leads to meditation of centering and grounding.
Interventions/Control_2	The control is to take a relaxed closed eyes resting posture once a day for 12 weeks according to the 7 minutes original voice guidance by media player. This voice guidance leads to a relaxed and comfortable posture.
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	The person engaged in elderly care
Key exclusion criteria	The family caregiver The person who can't work for 3 months
Target sample size	40

Research contact person
Name of lead principal investigator	Asami HONGO
Organization	Yokohama Soei Univeresity
Division name	Faculty of nursing
Address	1 Miho-cho, Midori-ku, Yokohama-city, Kanagawa-pref., Japan
TEL	+81459226061
Email	a.hongo@soei.ac.jp

Public contact
Name of contact person	Asami HONGO
Organization	Yokohama Soei Univeresity
Division name	Faculty of nursing
Address	1 Miho-cho, Midori-ku, Yokohama-city, Kanagawa-pref., Japan
TEL	+81459226061
Homepage URL
Email	a.hongo@soei.ac.jp

Sponsor
Institute	Yokohama Soei University
Institute
Department

Funding Source
Organization	Ministry of education
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 12 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 14 Day
Anticipated trial start date	2016 Year 12 Month 22 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 06 Month 30 Day
Date trial data considered complete	2018 Year 01 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 31 Day
Last modified on	2018 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029336