UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055744 |
|---|---|
| Receipt number | R000063701 |
| Scientific Title | A randomized controlled trial to explore the effects of connectedness focused loving-kindness meditation on eudaimonic well-being. |
| Date of disclosure of the study information | 2024/10/05 |
| Last modified on | 2025/04/09 18:14:14 |
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Basic information
Public title
Connectedness focused loving-kindness meditation
Acronym
A RCT of Connectedness focused loving-kindness meditation
Scientific Title
A randomized controlled trial to explore the effects of connectedness focused loving-kindness meditation on eudaimonic well-being.
Scientific Title:Acronym
A RCT of Connectedness focused loving-kindness meditation
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a 7-week session of connectedness focused loving-kindness meditation (CF-LKM) that incorporates a heart-beat message using a cushion-type experimental device, and to clarify through a randomized controlled trial that it has a greater effect on connectedness and non-arousal-type positive emotions than the conventional intervention of loving-kindness meditation (LKM) alone. Using connectedness as the primary indicator, we predict that CF-LKM will improve positive emotions (measuring daily emotional states) more than LKM, and that this will in turn increase psychological resources (connectedness, resilience, mindfulness, and self-compassion) and well-being (life satisfaction, subjective well-being, sleep, depression, and anxiety).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total score of the Comprehensive Connectedness Scale-Trait version [ Time Frame: pre, post, one and three month follow-up ]
Key secondary outcomes
1) Wellbeing indices: Subjective happiness scale, Psychological well-being scale, Satisfaction with life scale, DASS-21,and Pittsburgh Sleep Quality Index [ Time Frame: pre, post, one and three month follow-up ]
2) Psychological indices: Mindful Attention Awareness Scale, Self-compassion Scale, ego-resilience scale, and Adolescent Resilience Scale [ Time Frame: pre, post, one and three month follow-up ]
3)Daily affect: Comprehensive connectedness scale state version and Multiple mood scale. [ Time Frame: pre, post, one and three month follow-up ]
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
A seven-week Connectedness focused loving-kindness meditation program (weekly 80-min in-person session, everyday homework)
Interventions/Control_2
A seven-week loving-kindness meditation program (weekly 80-min in-person session, everyday homework)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged from 18 years old at the time of consent.
2) Individuals who use their own PC or smartphone.
3) Individuals who are able to participate in all 7 sessions once a week.
4) Individuals who are able to wake up by 9am during the participation period.
5) Individuals who are able to do homework every day.
Key exclusion criteria
1) Individuals currently receiving medical treatment.
2) Individuals with suicidal thoughts.
3) Individuals wearing a medical device.
4) Individuals with poor health.
5) Individuals who have history of epileptic seizure.
6) Individuals with body temperature dysregulation.
7) Individuals with irregular heartbeat.
8) Individuals with voice, hearing or grip strength disorder.
9) Individuals with communication disorder.
10) Individuals with heart-related illness.
11) Individuals without strenuous exercise, eating, smoking, or the consumption of caffeine or alcohol within one hour of the start of the intervention on the day.
12) Individuals who experienced an intervention with meditation practices.
13) Other persons deemed inappropriate by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kohki |
| Middle name | |
| Last name | Arimitsu |
Organization
Kwansei Gakuin University
Division name
Department of Psychological Science
Zip code
662-8501
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo 662-8501, Japan
TEL
080-1361-9039
arimitsu@kwansei.ac.jp
Public contact
Name of contact person
| 1st name | Kohk |
| Middle name | |
| Last name | Arimitsu |
Organization
Kwansei Gakuin University
Division name
Department of Psychological Science
Zip code
662-8501
Address
1-155 Uegahara Ichiban-cho, Nishinomiya, Hyogo 662-8501, Japan
TEL
080-1361-9039
Homepage URL
arimitsu@kwansei.ac.jp
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Sony Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kwansei Gakuin University
Address
1, Gakuen Uegahara, Sanda, Hyogo, 669-1330, Japan
Tel
079-565-9052
med-ethic@kwansei.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
関西学院大学（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063701
