UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005364
Receipt number R000004022
Scientific Title Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial
Date of disclosure of the study information 2011/04/01
Last modified on 2012/04/02 20:14:41

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Basic information

Public title

Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial

Acronym

Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial

Scientific Title

Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial

Scientific Title:Acronym

Reduction of stress and prevention of metabolic syndrome through music and laugh: randomized-controlled trial

Region

Japan


Condition

Condition

normal to high blood pressure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of music and laughter on blood pressure and reduction of stress.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I


Assessment

Primary outcomes

blood pressure, heart rate, and coltisol

Key secondary outcomes

perceived stress, lifestyle behaviors (diet, exercize, alcohol intake, sleep duration etc.) hours of listening music and laughter at home, Augmentation index, biochemical examination, peripheral blood examination, hemoglobin A1c and immunological test


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

Health Education and Music Intervention
Music Intervention: Conducted mainly by two music therapists. The sessions were
composed of listening to, singing and stretching with music. Participants were also encouraged to listen to music at home.

Interventions/Control_2

Health Ecucation and Laughter Intervention
Laughter Intervention: Conducted by trained laughter yoga leaders.The sessions were composed of breathing exercises with laughter that's stimulated through playful eye contact, and watched Rakugo, Japanese traditional sit-down comedy. Participants were also encouraged to do laughter yoga at home.

Interventions/Control_3

Healhty Education Only

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

40 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

no critical disease and possible to participate intervention.

Key exclusion criteria

have critical disease and impossible to participate in intervention.

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroyasu Iso

Organization

Osaka University Graduate School of Medicine

Division name

Public Health

Zip code


Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3911

Email



Public contact

Name of contact person

1st name
Middle name
Last name Eri Eguchi

Organization

Osaka University Graduate School of Medicine

Division name

Public Health

Zip code


Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3911

Homepage URL


Email



Sponsor or person

Institute

Public Health, Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

2011 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2009 Year 11 Month 24 Day

Date of IRB


Anticipated trial start date

2009 Year 11 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

2011 Year 04 Month 01 Day

Last modified on

2012 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004022


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name