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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046699
Receipt No. R000053276
Scientific Title Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Date of disclosure of the study information 2022/01/24
Last modified on 2022/04/30

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Basic information
Public title Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Acronym Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Scientific Title Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Scientific Title:Acronym Effects of Mindfulness Meditation Intervention on Mindlessness and Interpersonal Attitudes.
Region
Japan

Condition
Condition Adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examine whether mindfulness meditation reduces mindlessness and causes changes in interpersonal attitudes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Mindlessness Scale
Key secondary outcomes 1)Picture Frustration Study
2)The Japanese version of Five Facet Mindfulness Questionnaire
3)Homework Records

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 This study conduct lecture on mindfulness(psycho-education on mindfulness and mindfulness meditation, mindfulness meditation practice) of about one hour each for 8 weeks.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1)People who are at least 20 years old at the time of informed consent.
2)People willing and able to give informed consent.
Key exclusion criteria 1)People who have difficulty in verbal communication with the principle investigator or research member.
2)unable to understand psycho-education on mindfulness and the instruction of mindfulness meditation.
3)unable to reflect on and report changes in thoughts and feelings as a result of the intervention.
4)unable to understand and respond to the content of the measurement scales.
5)practice mindfulness meditation on the daily basis.
6)may cause dissociation or flashbacks when mindfulness meditation is practiced(e.g., Post-Traumatic Stress Disorder;Dissociative Disorder).
7)any condition which in the investigator's opinion, endangered the patient if he or she participated in this intervention.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name masahiko
Middle name
Last name inoue
Organization Tottori University
Division name Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code 683-8503
Address 86 Nishi-cho,Yonago-shi,Tottori Japan
TEL 0859386410
Email masahiko-inoue@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name kengo
Middle name
Last name Yuruki
Organization Tottori University
Division name Department of Clinical Psychology, Graduate School of Medical Sciences
Zip code 683-8503
Address 86 Nishi-cho,Yonago-shi,Tottori Japan
TEL 0859386410
Homepage URL
Email yurukikng.gel157@gmail.com

Sponsor
Institute Tottori University
Institute
Department

Funding Source
Organization Tottori 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 Department of Clinical Psychology, Graduate School of Medical Sciences, Tottori University
Address 86 Nishi-cho,Yonago-shi,Tottori Japan
Tel 0859386410
Email M20M4010A@edu.tottori-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
2022 Year 01 Month 24 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 19
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
2022 Year 01 Month 14 Day
Date of IRB
2022 Year 01 Month 05 Day
Anticipated trial start date
2022 Year 02 Month 07 Day
Last follow-up date
2022 Year 04 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 01 Month 23 Day
Last modified on
2022 Year 04 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053276

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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