UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000053989
Receipt number R000061632
Scientific Title The impact of dancing on mothers' stress while raising children
Date of disclosure of the study information 2024/03/28
Last modified on 2024/03/28 04:00:46

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Basic information

Public title

The impact of dancing on mothers' stress while raising children

Acronym

The impact of dancing on mothers' stress

Scientific Title

The impact of dancing on mothers' stress while raising children

Scientific Title:Acronym

The impact of dancing on mothers' stress

Region

Japan


Condition

Condition

Childcare stress, childcare anxiety

Classification by specialty

Obstetrics and Gynecology Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Clarifying the impact of dancing together with mother and child on childcare stress faced by mothers.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measure cerebral blood flow once a week for 4 weeks.

Key secondary outcomes

Have them complete the PSI-SF once a week for 4 weeks.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

Dance intervention for mother and child once a week for 4 weeks. Each intervention lasts about 30 minutes and involves easy exercise with an exercise intensity of about 25%.

Interventions/Control_2


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

5 months-old <=

Age-upper limit

49 years-old >=

Gender

Male and Female

Key inclusion criteria

mother raising a child

Key exclusion criteria

Those who have a disease or injury that prevents them from dancing.

Target sample size

140


Research contact person

Name of lead principal investigator

1st name Toshio
Middle name
Last name Murayama

Organization

Niigata University

Division name

Department of Humanities and Social Sciences

Zip code

950-2181

Address

8050 Ikarashi 2nomachi, Nishi-ku, Niigata City

TEL

025-262-7076

Email

murayama@ed.niigata-u.ac.jp


Public contact

Name of contact person

1st name Keiko
Middle name
Last name Ikeda

Organization

Niigata University

Division name

Graduate School of Contemporary Social Culture

Zip code

950-2181

Address

8050 Ikarashi 2nomachi, Nishi-ku, Niigata City

TEL

080-9178-6112

Homepage URL


Email

kk020020@mail.cc.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University

Institute

Department

Personal name



Funding Source

Organization

Niigata University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Niigata University Ethics Review Committee for Research Involving Human Subjects

Address

8050 Igarashi 2nomachi, Nishi-ku, Niigata City

Tel

025-227-2625

Email

ethics@adm.niigata-u.ac.jp


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

2024 Year 03 Month 28 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

2023 Year 10 Month 20 Day

Date of IRB

2023 Year 10 Month 20 Day

Anticipated trial start date

2024 Year 03 Month 31 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2024 Year 03 Month 28 Day

Last modified on

2024 Year 03 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061632


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name