UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056370 |
|---|---|
| Receipt number | R000064409 |
| Scientific Title | The effect of wearing noise-canceling headphones during dental treatment on dental noise and autonomic nervous activity |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2024/12/05 14:32:48 |
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Basic information
Public title
The effect of wearing noise-canceling headphones during dental treatment on dental noise and autonomic nervous activity
Acronym
The effect of wearing noise-canceling headphones during dental treatment on dental noise and autonomic nervous activity
Scientific Title
The effect of wearing noise-canceling headphones during dental treatment on dental noise and autonomic nervous activity
Scientific Title:Acronym
The effect of wearing noise-canceling headphones during dental treatment on dental noise and autonomic nervous activity
Region
| Japan |
Condition
Condition
Calculus on the crown of the tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a treatment environment that reduces the impact of dental noise on the body, and to investigate the effect of wearing noise-canceling headphones during dental treatment on dental noise and autonomic nervous activity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LF/HF
Key secondary outcomes
Parasympathetic nervous activity index (HF) heart rate, blood pressure, loudness, frequency, psychological state
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Noise Cancellation
Interventions/Control_2
No noise cancelling
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Among the 40 women aged 20 to 40 who applied after seeing the poster, the dentist judged that scaling (removal of tartar from the crown of the tooth using an ultrasonic scaler that generates ultrasonic waves from the tip of the instrument) was necessary.
3.1. Eligibility criteria
1. Cases that the dentist judged to be necessary
2. Women aged 20-40
3. Cases that can be examined in the outpatient clinic
Key exclusion criteria
1.Patients with arrhythmia
2.Patients with a disease that affects the autonomic nervous system
3.Patients with allergies to medications
4.Patients taking oral benzodiazepines
5.Women who are pregnant, may be pregnant, have given birth within 28 days, or are breastfeeding
6.Other cases that a dentist determines are unsuitable
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Dental Anesthesiology
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
TEL
0992756288
kaorun@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Dental Anesthesiology
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan
TEL
0992756288
Homepage URL
kaorun@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical and Dental Sciences, Kagoshima 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
Graduate School of Medical and Dental Sciences, Kagoshima University
Address
8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
Tel
0992756624
crmc@m2.kufm.kagoshima-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
| 2024 | Year | 12 | Month | 05 | 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
| 2024 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 16 | 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
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064409
