UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049556 |
|---|---|
| Receipt number | R000056433 |
| Scientific Title | Effects of relaxation on the oral-facial region during dental treatment on the autonomic nervous system |
| Date of disclosure of the study information | 2022/11/18 |
| Last modified on | 2025/05/21 19:18:53 |
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Basic information
Public title
Effects of relaxation on the oral-facial region during dental treatment on the autonomic nervous system
Acronym
Effects of relaxation on the oral-facial region during dental treatment on the autonomic nervous system
Scientific Title
Effects of relaxation on the oral-facial region during dental treatment on the autonomic nervous system
Scientific Title:Acronym
Effects of relaxation on the oral-facial region during dental treatment on the autonomic nervous system
Region
| Japan |
Condition
Condition
dental phobia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify that relaxation to the oral-facial region during dental treatment has a relaxing effect and affects the activity of the autonomic nervous system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change in autonomic nervous system function
Key secondary outcomes
the changes in skin conductance and respiratory rate during dental treatment
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
hot eye mask with a heat- and steam-generating (HSG) sheet
Interventions/Control_2
inactivated HSG sheet
Interventions/Control_3
Headphones with music
Interventions/Control_4
noise-cancelling headphones
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Age 20 to 40
2) The Japanese version of the Dental Fear Survey (DFS) score is 21 or higher
3) Healthy volunteers who have never been diagnosed with a mental disorder or physical disability.
Key exclusion criteria
1) Persons who are unsuitable for applying electrode gel due to skin diseases, etc.
2) Persons who are judged to be inappropriate as research subjects by the investigators, etc.
3) Persons with psychiatric disorders or physical disabilities other than dental phobia
4) Persons who have hypersensitivity and moving on mandible tooth
5) Persons who are research subjects, but actually feel discomfort after wearing either HSG sheet, control sheet, or the headphones, and who give up during the session.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Hanako |
| Middle name | |
| Last name | Kawasaki |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Developmental and Nurturing Dentistry
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
0958197674
h.kawasaki@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hanako |
| Middle name | |
| Last name | Kawasaki |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Developmental and Nurturing Dentistry
Zip code
8528501
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
TEL
0958197674
Homepage URL
h.kawasaki@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
Nagasaki university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki City, Nagasaki, Japan
Tel
0958197674
h.kawasaki@nagasaki-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
| 2022 | Year | 11 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
30
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
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 11 | Month | 18 | Day |
Last modified on
| 2025 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056433
