UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021700
Receipt number R000025037
Scientific Title Mixed methods outcome evalute of coaching on stress-cognition in mothers with young children
Date of disclosure of the study information 2016/12/31
Last modified on 2016/03/31 11:13:02

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Basic information

Public title

Mixed methods outcome evalute of coaching on stress-cognition in mothers with young children

Acronym

Mixed methods outcome evalute of coaching

Scientific Title

Mixed methods outcome evalute of coaching on stress-cognition in mothers with young children

Scientific Title:Acronym

Mixed methods outcome evalute of coaching

Region

Japan


Condition

Condition

health

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to evaluate mixed methods outcome of a coaching program on stress-cognition in normal healthy mothers with young children.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

stress-cognition(qualitively)

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom Other

Interventions/Control_1

The intervention comprise five sessions. One session is 120 minutes.

Interventions/Control_2

The intervention comprise five sessions. One session is 120 minutes.

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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

Mothers of young children aged 3 months to 6 years in Japan.

Key exclusion criteria

No applicable

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ohahsi Junko

Organization

Kyoto Prefectural University of Medicine

Division name

Graduate School of Nursing

Zip code


Address

465 Kajii-cho Kawaramachi Agaru Hirokoji Kamigyo-ku Kyoto

TEL

075-212-5440

Email

johashi@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ohahsi Junko

Organization

Kyoto Prefectural University of Medicine

Division name

Graduate School of Nursing

Zip code


Address

465 Kajii-cho Kawaramachi Agaru Hirokoji Kamigyo-ku Kyoto

TEL

075-212-5440

Homepage URL


Email

johashi@koto.kpu-m.ac.jp


Sponsor or person

Institute

Kyoto Prefectural University of Medicine Graduate School of Nursing

Institute

Department

Personal name



Funding Source

Organization

Kyoto Prefectural University of Medicine

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


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

2016 Year 12 Month 31 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

2016 Year 10 Month 30 Day

Date of IRB


Anticipated trial start date

2016 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

2016 Year 03 Month 31 Day

Last modified on

2016 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025037


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name