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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017088
Receipt No. 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

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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
Last 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
Email kawanami@den.hokudai.ac.jp

Public contact
1st 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
Email shinji@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019822

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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