UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043298
Receipt number R000049416
Scientific Title The effect of brief mindfulness induction to incidence of inattentional blindness and accuracy of inattentional blindness task
Date of disclosure of the study information 2021/02/16
Last modified on 2022/02/16 16:49:32

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Basic information

Public title

The effect of brief mindfulness induction to incidence of inattentional blindness and accuracy of inattentional blindness task

Acronym

Inattentional blindness and mindfulness

Scientific Title

The effect of brief mindfulness induction to incidence of inattentional blindness and accuracy of inattentional blindness task

Scientific Title:Acronym

Inattentional blindness and mindfulness

Region

Japan


Condition

Condition

Healthy subects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we want to explore in depth whether mindfulness practice have the effect of lowering inattenional blindness of athletes, and for the demanding task whether the accuracy will have an impact with the change of it. Then to clarify whether it affects and how different team ball sports athletes have made.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

For athletes, IB is a very important blind spot for sports performance and competition results, and from now on, there is no research had clarified the real mechanism of mindfulness intervention to incidence of IB. We will be the first study to use undirected graphical models to analyze and infer various possibilities of it. The outcome of our study may provide potential factors for further research on the occurrence of IB and intervention methods.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

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

Brief mindfulness

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

20 years-old <=

Age-upper limit

35 years-old >=

Gender

Male and Female

Key inclusion criteria

1) 20 years old and over, 35 years old and under
2) Gender regardless of gender
3) No experience with mindfulness meditation or other types of meditation.
4) Recruitment criteria for 2 groups:
a.Athlete group: Who are major in physical education of a sport university and have regular practice of team sports (Team ball sports that need to track multiple items while competition, basketball, soccer, American football, rugby, floorball). The participants needs to practice the certain sport for at least 8-12 years and participating in inter-school competitions every year.
b.Non-athlete group participants are from the other colleges of the school with no regular sport practice, exercise and no more than 2 years of formal experience in any sport.
5) Those who have agreed in writing to the detailed explanation of the study

Key exclusion criteria

1) People with red or green dysfunction
2) People with a history of neuropathy or cardiovascular disease
3) People with infectious diseases (influenza, etc.)
4) People with audiovisual disabilities
5) People with food allergies (raisins)

Target sample size

147


Research contact person

Name of lead principal investigator

1st name Ryoichi
Middle name
Last name Nagatomi

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code

980-8575

Address

Seiryo-machi 2-1, Aoba-ku, Sendai

TEL

022-717-8586

Email

nagatomi@med.tohoku.ac.jp


Public contact

Name of contact person

1st name Ichen
Middle name
Last name Yu

Organization

Tohoku University Graduate school of medicine

Division name

Medicine and Science in Sports and Exercise

Zip code

980-8575

Address

3F School of Medicine Building 4 2-1 Seiryo-machi, Aoba-ku, Sendai

TEL

070-4013-4220

Homepage URL


Email

yuichen@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku university

Institute

Department

Personal name



Funding Source

Organization

Tohoku 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

Ethics Committee Tohoku University Graduate School of Medicine

Address

Seiryo-machi 2-1, Aoba-ku, Sendai

Tel

022-717-8007

Email

med-kenkyo@grp.tohoku.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

2021 Year 02 Month 16 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

103

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

No longer recruiting

Date of protocol fixation

2021 Year 02 Month 16 Day

Date of IRB

2021 Year 02 Month 15 Day

Anticipated trial start date

2021 Year 02 Month 16 Day

Last follow-up date

2022 Year 03 Month 16 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 02 Month 10 Day

Last modified on

2022 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049416


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name