UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017088 |
|---|---|
| Receipt number | R000019822 |
| Scientific Title | Effect of music sedation on psychological stress due to less invasive conservative dental treatment in patients with dental anxiety: Evaluation by autonomic nervous activity using heart rate variability |
| Date of disclosure of the study information | 2015/04/15 |
| Last modified on | 2015/04/09 22:00:07 |
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Basic information
Public title
Effect of music sedation on psychological stress due to less invasive conservative dental treatment in patients with dental anxiety: Evaluation by autonomic nervous activity using heart rate variability
Acronym
Effect of music sedation on psychological stress due to conservative dental treatment in patients with dental anxiety
Scientific Title
Effect of music sedation on psychological stress due to less invasive conservative dental treatment in patients with dental anxiety: Evaluation by autonomic nervous activity using heart rate variability
Scientific Title:Acronym
Effect of music sedation on psychological stress due to conservative dental treatment in patients with dental anxiety
Region
| Japan |
Condition
Condition
Periodontal disease, Endodontic disease
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of music sedation on psychological stress due to conservative dental treatment in patients with dental anxiety
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
LF/HF value during conservative dental treatment in patients with dental anxiety
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) 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
Dental treatment with music sedation in interventions.
Interventions/Control_2
Dental treatment without music sedation in control.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients without arrhythmic and psychiatric disease and hearing disorder
Key exclusion criteria
Minor
Patients with arrhythmic or psychiatric disease or hearing disorder
Target sample size
84
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masamitsu Kawanami |
Organization
Hokkaido University
Division name
Periodontology and Endodontology
Zip code
Address
N13 W7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-4266
kawanami@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Shimoji |
Organization
Hokkaido University
Division name
Periodontology and Endodontology
Zip code
Address
N13 W7, Kita-ku, Sapporo, Hokkaido
TEL
011-706-4266
Homepage URL
shinji@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido 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
Address
Tel
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
| 2015 | Year | 04 | Month | 15 | 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
| 2013 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 09 | Day |
Last modified on
| 2015 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019822
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
