UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060814 |
|---|---|
| Receipt number | R000069583 |
| Scientific Title | The Effect of a Self-Care Intervention on Posture and Autonomic Stress Responses in University Students: Focusing on Physiological Load During Smartphone Use |
| Date of disclosure of the study information | 2026/03/03 |
| Last modified on | 2026/03/03 23:35:37 |
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Basic information
Public title
The Effect of a Self-Care Intervention on Posture and Autonomic Stress Responses in University Students: Focusing on Physiological Load During Smartphone Use
Acronym
The Effect of a Self-Care Intervention on Posture and Autonomic Stress Responses in University Students: Focusing on Physiological Load During Smartphone Use
Scientific Title
The Effect of a Self-Care Intervention on Posture and Autonomic Stress Responses in University Students: Focusing on Physiological Load During Smartphone Use
Scientific Title:Acronym
The Effect of a Self-Care Intervention on Posture and Autonomic Stress Responses in University Students
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to objectively evaluate physiological stress responses associated with smartphone use and the poor postures adopted during use, using Spinal Mouse and salivary amylase, and to examine the effectiveness of a self-care intervention as an implementation approach to enhance Positive Health, defined as the ability to self-manage and adapt one's health.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Posture assessment: Posture during the stress-inducing task will be recorded using photographs and Spinal Mouse.
Stress response assessment: Saliva samples will be collected before and after the stress-inducing task, and salivary amylase will be measured.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention: Participants will perform an approximately 5-minute exercise session using an instructional video, for 4 weeks. The content will be as follows:
Intervention group: Neck and trunk exercises designed to improve posture.
Interventions/Control_2
Intervention: Participants will perform an approximately 5-minute exercise session using an instructional video, for 4 weeks. The content will be as follows:
Control group: Limb exercises expected to have minimal effects on posture (active control).
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
Key inclusion criteria
Healthy male students enrolled at Gunma University.
Individuals who have experience using a smartphone and currently own a smartphone.
Key exclusion criteria
Individuals with orthopedic conditions that would hinder completion of the intervention or measurements, or those advised by a physician to restrict exercise.
Individuals with a history of orthopedic disorders that could affect the intervention or measurement outcomes, such as deformities or functional impairments of the neck, shoulder girdle, thoracic spine, or thoracic cage.
Individuals unable to view the intervention instructional videos on their smartphone.
Individuals with severe xerostomia (dry mouth) that makes saliva collection difficult.
Female participants.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Daigo |
| Middle name | |
| Last name | Kato |
Organization
Gunma University, Graduate school of health sciences
Division name
Department of Rehabilitation sciences
Zip code
3718514
Address
3-39-22, Showa, Maebashi, GUnma, JAPAN
TEL
027-220-8971
dkato@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Daigo |
| Middle name | |
| Last name | Kato |
Organization
Gunma university, Graduateschool of health sciences
Division name
Department of Rehabilitation sciences
Zip code
3718514
Address
3-39-22, Showa, Maebashi, GUnma, JAPAN
TEL
027-220-8971
Homepage URL
dkato@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
Funding Source
Organization
Foundation for Total Health Promotion
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-15, Showa, Maebashi, Gunma
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
| 2026 | Year | 03 | Month | 03 | 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
| 2026 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 03 | Month | 03 | Day |
Last modified on
| 2026 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069583
