UMIN-CTR Clinical Trial

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
Institute	Tohoku university
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049416