UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062391 |
|---|---|
| Receipt number | R000071322 |
| Scientific Title | Factor structure, reliability, and validity of the Japanese version of the Gagging Problem Assessment-Revised patient section and its association with anesthetic drug dose |
| Date of disclosure of the study information | 2026/08/01 |
| Last modified on | 2026/07/23 23:37:02 |
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Basic information
Public title
A study of the reliability and usefulness of a Japanese questionnaire for assessing problematic gagging during dental treatment
Acronym
Japanese GPA-R-pa Study
Scientific Title
Factor structure, reliability, and validity of the Japanese version of the Gagging Problem Assessment-Revised patient section and its association with anesthetic drug dose
Scientific Title:Acronym
Japanese GPA-R-pa Validation Study
Region
| Japan |
Condition
Condition
Problematic gagging during dental treatment (exaggerated gag reflex)
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a Japanese version of the Gagging Problem Assessment-Revised patient section (GPA-R-pa) and evaluate its factor structure, internal consistency, criterion-related validity, convergent validity, and discriminant validity among adult patients referred or re-referred to the Anxiety-Free Dental Treatment Unit of the Department of Dental Anesthesiology at Hiroshima University Hospital. The study will also explore the association between the Japanese GPA-R-pa score and anesthetic drug dose at the first dental anesthesia session among patients receiving intravenous anesthesia or intravenous sedation.
Basic objectives2
Others
Basic objectives -Others
Psychometric evaluation of a Japanese questionnaire and analysis of its association with anesthetic drug dose
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Factor structure of the Japanese GPA-R-pa based on responses collected at the pre-anesthetic interview. The number of factors, factor loadings, and model fit will be evaluated using exploratory and confirmatory factor analyses.
Key secondary outcomes
Internal consistency of the Japanese GPA-R-pa at the pre-anesthetic interview, assessed using Cronbach's alpha.
Criterion-related validity assessed by comparing Japanese GPA-R-pa scores between patients referred because of problematic gagging and those referred for other reasons.
Convergent validity assessed by correlations of Japanese GPA-R-pa scores with Modified Dental Anxiety Scale (MDAS) and Specific Phobia of Vomiting Inventory (SPOVI) scores.
Discriminant validity assessed by the association between Japanese GPA-R-pa and State-Trait Anxiety Inventory (STAI) scores.
Base
Study type
Observational
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
1. Aged 18 years or older.
2. Referred or re-referred to the Anxiety-Free Dental Treatment Unit of the Department of Dental Anesthesiology at Hiroshima University Hospital for dental anesthesia management (intravenous anesthesia/intravenous sedation, inhalation sedation, or general management).
3. Able to read and write Japanese and independently complete the questionnaires.
4. Provision of consent to participate by checking the consent box in Google Forms after reviewing the study information.
Key exclusion criteria
1. Unable to read or write Japanese.
2. Unable to complete the questionnaires independently.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Oda |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Dental Anesthesiology
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
TEL
082-257-5733
aya-danesth2020@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Oda |
Organization
Graduate School of Biomedical and Health Sciences, Hiroshima University
Division name
Department of Dental Anesthesiology
Zip code
734-8553
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
TEL
082-257-5733
Homepage URL
aya-danesth2020@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
University of Turku
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Epidemiology of Hiroshima University
Address
1-2-3 Kasumi, Minami-ku, Hiroshima 734-8553, Japan
Tel
082-257-5907
iryo-sinsa@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
E2025-0295
Org. issuing International ID_1
Ethical Committee for Epidemiology of Hiroshima University
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 | 08 | Month | 01 | 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 | 02 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective, single-center observational study for questionnaire validation. Adults aged 18 years or older who are referred or re-referred to the Anxiety-Free Dental Treatment Unit of the Department of Dental Anesthesiology at Hiroshima University Hospital for dental anesthesia management, meet the eligibility criteria, and provide consent will be enrolled during the recruitment period [sampling method to be confirmed]. A single self-administered survey will be conducted using Google Forms at the pre-anesthetic interview to collect the Japanese GPA-R-pa, MDAS, SPOVI, STAI, and patient background information. Observed factors include questionnaire scores, patient characteristics, and reason for referral. The main outcomes are the factor structure, internal consistency, criterion-related validity, convergent validity, and discriminant validity of the Japanese GPA-R-pa. For patients receiving intravenous anesthesia or intravenous sedation, anesthetic drug dose at the first dental anesthesia session will be extracted from medical records and its association with the Japanese GPA-R-pa score will be evaluated. Recruitment will continue from the date of institutional permission through June 30, 2027, with a target sample size of 200.
Management information
Registered date
| 2026 | Year | 07 | Month | 29 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071322
