UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054383 |
|---|---|
| Receipt number | R000062072 |
| Scientific Title | An Examination of the Influence of Alexithymia on Bronchial Asthma (Psychosomatic) Tendency and the Mediating Role of Stress Coping Styles |
| Date of disclosure of the study information | 2024/05/14 |
| Last modified on | 2025/02/03 09:33:14 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examining the Influence of Emotional Awareness and Stress Coping Strategies on Asthma-Like Symptoms
Acronym
Examining the Influence of Emotional Awareness and Stress Coping Strategies on Asthma-Like Symptoms
Scientific Title
An Examination of the Influence of Alexithymia on Bronchial Asthma (Psychosomatic) Tendency and the Mediating Role of Stress Coping Styles
Scientific Title:Acronym
An Examination of the Influence of Alexithymia on Bronchial Asthma (Psychosomatic) Tendency and the Mediating Role of Stress Coping Styles
Region
| Japan |
Condition
Condition
Bronchial asthma (psychosomatic disorder)
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to investigate the impact of alexithymia on bronchial asthma (psychosomatic disorder) through the mediation of stress coping
Basic objectives2
Others
Basic objectives -Others
We aim to investigate the influence of the total score of the Japanese version of the Bermond-Vorst Alexithymia Questionnaire (BVAQ-J) on the score of bronchial asthma (psychosomatic disorder), mediated by the scores of the Coping Scale Characteristics Version (GCQ) subscales.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
We aim to investigate the influence of the total score of the Japanese version of the Bermond-Vorst Alexithymia Questionnaire (BVAQ-J) on the score of bronchial asthma (psychosomatic disorder), mediated by the scores of the Coping Scale Characteristics Version (GCQ) subscales. In terms of statistical analysis, we will conduct a mediation analysis with the explanatory variable as the BVAQ-J total score, the mediating variable as the GCQ subscale scores, and the outcome variable as the presence or absence of bronchial asthma (psychosomatic disorder).
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Individuals who understand the purpose of the study and provide written consent to participate (as consent from the participants is required for participation in the study).
2.Individuals aged 18 and above at the time of study participation (as the study targets adults).
Key exclusion criteria
Without any special notes.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo
TEL
0798544517
hisaono@kwansei.ac.jp
Public contact
Name of contact person
| 1st name | Hisae |
| Middle name | |
| Last name | Ono |
Organization
Kwansei Gakuin University
Division name
Department of Integrated Psychological Sciences, School of Humanities
Zip code
662-8501
Address
1-155 Uegahara Ichibancho, Nishinomiya, Hyogo
TEL
0798544517
Homepage URL
hisaono@kwansei.ac.jp
Sponsor or person
Institute
Kwansei Gakuin University
Institute
Department
Personal name
Funding Source
Organization
kwansei Gakuin 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
Ethics Committee for Life Science and Medical Research Involving Human Subjects
Address
Gakuen Uegahara 1 ban Sanda, Hyogo
Tel
0795659052
med-ethic@kwansei.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
23-04
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
| 2024 | Year | 05 | Month | 14 | 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
1025
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
Completed
Date of protocol fixation
| 2024 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A research study by recruiting participants online using a crowdsourcing service (Lancers: https://www.lancers.jp/help/terms)."
Management information
Registered date
| 2024 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062072
