UMIN-CTR Clinical Trial

Basic information
Public title	Does mindfulness training reduce performance decline in pitchers?
Acronym	Mindfulness reduces performance decline in pitchers.
Scientific Title	The Effects of Mindfulness Training on the Prevention of Performance Decline in Pitchers.
Scientific Title:Acronym	The Effects of Mindfulness Training on the Prevention of Performance Decline in Pitchers
Region	Japan

Condition
Condition	Pitchers on college baseball teams.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine whether implementing a mindfulness meditation program for pitchers can reduce the decline in performance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Degree of variability in control of pitches
Key secondary outcomes	Five Facet Mindfulness Questionnire.

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	Mindfulness training
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	A student who is a member of a university baseball team and is a pitcher.
Key exclusion criteria	Those who have experienced significant psychological distress or extreme trauma in the past or immediately prior to the intervention. Those who have a history of mental illness. Those who are currently hospitalized or taking medication for any disease. Those who are currently participating in an intervention program study similar to this study. Those who belong to a baseball team of a university but are not pitchers.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yoshinori Middle name Last name Ito
Organization	University of the Ryukyus
Division name	Faculty of Humanity and Social Science
Zip code	900
Address	1 Senbaru, Nishihara, Okinawa, 903-0213, Japan
TEL	098-895-8423
Email	gitoku@hs.u-ryukyu.ac.jp

Public contact
Name of contact person	1st name Kazunori Middle name Last name Toyoshima
Organization	University of the Ryukyus
Division name	Faculty of Humanity and Social Science
Zip code	903-0213
Address	1Senbaru, Nishihara, Okinwa, 903-0213, Japan
TEL	098-895-8423
Homepage URL
Email	yidelidao@gmail.com

Sponsor
Institute	University of the Ryukyus
Institute
Department

Funding Source
Organization	University of the Ryukyus
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	University of the Ryukyus
Address	1Senbaru, Nishihara, Okinwa, 903-0213, Japan
Tel	098-895-8423
Email	gitoku@hs.u-ryukyu.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 10 Month 01 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	2021 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2022 Year 03 Month 01 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 09 Month 03 Day
Last modified on	2021 Year 09 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051735