UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062372 |
|---|---|
| Receipt number | R000071379 |
| Scientific Title | Development and Evaluation of an Arts-Based Verbal and Nonverbal Communication Intervention Program: A Pre-Post Comparative Study Focusing on Self-Isolation Intention, Loneliness, and Mental Health |
| Date of disclosure of the study information | 2026/07/28 |
| Last modified on | 2026/07/28 17:25:51 |
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Basic information
Public title
Development and Evaluation of an Arts-Based Verbal and Nonverbal Communication Intervention Program: A Pre-Post Comparative Study Focusing on Self-Isolation Intention, Loneliness, and Mental Health
Acronym
Development and Pre-Post Evaluation of an Arts-Based Communication Intervention Program
Scientific Title
Development and Evaluation of an Arts-Based Verbal and Nonverbal Communication Intervention Program: A Pre-Post Comparative Study Focusing on Self-Isolation Intention, Loneliness, and Mental Health
Scientific Title:Acronym
Development and Pre-Post Evaluation of an Arts-Based Communication Intervention Program
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop an art-based verbal and nonverbal communication intervention program in a group format and to examine its effects on enhancing perceived connectedness with others and mood state, and reducing self-isolation intention, loneliness, and isolation outside working hours, using a pre-post design among employees.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Self-Isolation Intention (T0: baseline, T1: pre-intervention, T2: post-intervention, T3: 1-month follow-up)
Key secondary outcomes
Perceived connectedness with others (single-item measure) (T0, T1, T2, T3)
Intensity of loneliness (single-item measure) (T0, T1, T2, T3)
Temporary Mood Scale (T1, T2)
Japanese version of the UCLA Loneliness Scale (T0, T3)
Mood State (T0, T3)
Degree of Isolation Outside Working Hours (T0, T3)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
The intervention will be conducted as an in-person workshop. The target sample size for the study is 42 participants, with approximately 8-12 participants per group and a total of 4-6 groups. The intervention will be completed in a single day, with a total duration of approximately 5.5 hours, including a 1-hour break and 30 minutes allocated for questionnaire completion before and after the intervention. The program will consist of two sessions, each lasting 120 minutes. The intervention will include several exercises incorporating simple body movements and art-based activities. Specifically, the activities will include a name introduction game, a stone exchange exercise, rhythm and music activities, paired hand improvisation, awareness drawing, group sharing and dialogue, and free writing. The overall structure of the program will follow the sequence: warm-up -> introduction -> theme-based experiential activities -> sharing of experiences -> cool-down. Participants will first engage in nonverbal experiential activities, followed by reflection and verbal sharing of their feelings and insights gained from the experience. Opportunities for dialogue and interaction among participants will also be provided.
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
Individuals who currently reside in Japan, are aged 20-60 years, and are currently employed by a company or organization.
Individuals of any gender, occupation, or employment status.
Individuals who are able to communicate basically in Japanese to the extent that they can participate in dialogue and workshop activities without difficulty.
Individuals who understand the purpose and procedures of the study and are able to provide written informed consent.
Key exclusion criteria
Individuals who have difficulty participating in the mild physical activities planned in the study due to physical reasons.
Individuals who have been advised by a physician to restrict exercise or physical activity.
Individuals who report that participation in the planned activities (including interpersonal exercises, close physical interactions, and physical contact) may cause significant psychological burden or distress.
Individuals for whom it is apparent at the time of obtaining informed consent that continued participation throughout the study period will be difficult.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yasukazu |
| Middle name | |
| Last name | Ogai |
Organization
University of Tsukuba
Division name
Faculty of Medicine
Zip code
305-8577
Address
Room 743 of Advanced Research Building D, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki Prefecture, Japan
TEL
029-853-3099
ogai.ys@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Yichunzi |
| Middle name | |
| Last name | Li |
Organization
University of Tsukuba, Graduate School of Comprehensive Human Sciences
Division name
Doctoral Program in Human Care Science
Zip code
305-8577
Address
Room 743 of Advanced Research Building D, 1-1-1 Tennodai, Tsukuba, Ibaraki Prefecture, Japan
TEL
029-853-3099
Homepage URL
s2430449@u.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
Medical Ethics Committee, Faculty of Medicine, University of Tsukuba
Address
University of Tsukuba, 1-1-1, Tennodai, Tsukuba, Japan
Tel
029-853-3099
s2430449@u.tsukuba.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
| 2026 | Year | 07 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 28 | Day |
Last modified on
| 2026 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071379
