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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016422
Receipt No. R000019075
Scientific Title Investigation of stress-reducing effect of hearing laughter
Date of disclosure of the study information 2015/02/02
Last modified on 2018/08/10

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Basic information
Public title Investigation of stress-reducing effect of hearing laughter
Acronym Stress-reducing effect of laughter
Scientific Title Investigation of stress-reducing effect of hearing laughter
Scientific Title:Acronym Stress-reducing effect of laughter
Region
Japan

Condition
Condition healthy students
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the stress-reducing effect of hearing laughter both subjectively and objectively
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Phase II,III

Assessment
Primary outcomes inter-beat intervals
Key secondary outcomes blood pressure
psychological stress (VAS)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 hearing laughter
Interventions/Control_2 listening to music
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria healthy students attending a junior college
Key exclusion criteria those who were attending the hospital for treatment and menstruating women
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hitoshi Okamura
Organization Hiroshima University
Division name Institute of Biomedical & Health Sciences
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5450
Email hokamura@hiroshima-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hitoshi Okamura
Organization Hiroshima University
Division name Institute of Biomedical & Health Sciences
Zip code
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5450
Homepage URL http://home.hiroshima-u.ac.jp/psrlab/
Email hokamura@hiroshima-u.ac.jp

Sponsor
Institute Institute of Biomedical & Health Sciences, Hiroshima University
Institute
Department

Funding Source
Organization Hiroshima University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 02 Month 02 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 Completed
Date of protocol fixation
2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 10 Month 01 Day
Last follow-up date
2014 Year 09 Month 30 Day
Date of closure to data entry
2014 Year 10 Month 31 Day
Date trial data considered complete
2015 Year 01 Month 31 Day
Date analysis concluded
2015 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 02 Day
Last modified on
2018 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019075

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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