UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054970 |
|---|---|
| Receipt number | R000050018 |
| Scientific Title | Effect of listening to music during dental treatment under intravenous sedation on autonomic nervous system, electro-encephalogram, and psychological state |
| Date of disclosure of the study information | 2024/07/16 |
| Last modified on | 2024/10/27 23:22:17 |
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Basic information
Public title
Effect of listening to music during dental treatment under intravenous sedation on autonomic nervous system, electro-encephalogram, and psychological state
Acronym
Effect of listening to music during dental treatment under intravenous sedation on autonomic nervous system, electro-encephalogram, and psychological state
Scientific Title
Effect of listening to music during dental treatment under intravenous sedation on autonomic nervous system, electro-encephalogram, and psychological state
Scientific Title:Acronym
Effect of listening to music during dental treatment under intravenous sedation on autonomic nervous system, electro-encephalogram, and psychological state
Region
| Japan |
Condition
Condition
impacted mandibular third molar
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Intravenous sedation and listening to music during dental treatment are widely accepted as methods of providing safe dental treatment. However, it is not clear how listening to music during intravenous sedation dental treatment affects the human body and psychology.
Therefore, the purpose of this study is to see how listening to music during dental treatment under intravenous sedation affects autonomic nervous system, electro-encephalogram and psychological state.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LF/HF,HF,HR,SBP
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Listening to music (under experiment)
Interventions/Control_2
No listening to music (under experiment)
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
Cases where the dentist determines that tooth extraction under intravenous sedation is necessary
Key exclusion criteria
Cases with diseases that affect autonomic nerves and brain waves
Cases with a history of smoking in the past
Cases of taking medicine on a regular basis
Any woman who is pregnant, may become pregnant, within 28 days after giving birth, or breastfeeding
Subjects who are judged to be difficult to participate in the test due to mental illness or psychiatric symptoms
Other cases that the doctor judged to be maladaptated
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
Department of Dental Anesthesiology, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
TEL
099-275-6288
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, Kagoshima, Japan
Division name
Department of Dental Anesthesiology
Zip code
890-8544
Address
Department of Dental Anesthesiology, Graduate School of Medical and Dental Sciences, Kagoshima Unive
TEL
099-275-6288
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
This work was supported by JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
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, Kagoshima, Japan
Address
Department of Dental Anesthesiology, Graduate School of Medical and Dental Sciences, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
Tel
099-275-6288
kaorun@dent.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 | 07 | Month | 16 | Day |
Related information
URL releasing protocol
I will enter the information as soon as possible after the paper is published.
Publication of results
Unpublished
Result
URL related to results and publications
I will enter the information as soon as possible after the paper is published.
Number of participants that the trial has enrolled
40
Results
I will enter the information as soon as possible after the paper is published.
Results date posted
| 2024 | Year | 07 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
I will enter the information as soon as possible after the paper is published.
Participant flow
I will enter the information as soon as possible after the paper is published.
Adverse events
None
Outcome measures
LF/HF,HF,HR.SBP
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2023 | 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 | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050018
