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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024830
Receipt No. R000028578
Scientific Title A single blind RCT of relieving effect of music intervention on pre-treatment anxiety at dental treatment room in outpatient setting of dental anesthesia -from the perspective of autonomic nervous activity-
Date of disclosure of the study information 2017/01/04
Last modified on 2017/05/30

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Basic information
Public title A single blind RCT of relieving effect of music intervention on pre-treatment anxiety at dental treatment room in outpatient setting of dental anesthesia -from the perspective of autonomic nervous activity-
Acronym A RCT of relieving effect of music intervention on pre-treatment anxiety at dental treatment room in outpatient setting of dental anesthesia
Scientific Title A single blind RCT of relieving effect of music intervention on pre-treatment anxiety at dental treatment room in outpatient setting of dental anesthesia -from the perspective of autonomic nervous activity-
Scientific Title:Acronym A RCT of relieving effect of music intervention on pre-treatment anxiety at dental treatment room in outpatient setting of dental anesthesia
Region
Japan

Condition
Condition dental and oral diseases including impacted tooth, cyst or benign tumor in jawbone
Classification by specialty
Anesthesiology Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the effectiveness of music intervention on pre-treatment anxiety at dental treatment room in outpatient setting of dental anesthesia in using heart rate variability analysis from the perspective of autonomic nervous activity.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The low-frequency component divided by the high-frequency component (LF/HF) is analyzed as the primary outcome indicator of sympathetic nervous activity from entering dental treatment room in outpatient setting of dental anesthesia until immediately before starting intravenous sedation.
Key secondary outcomes HF for parasympathetic nervous activity, the coefficient of variance of R-R intervals (CVRR), visual analog scale as indicator of subjective anxiety, and heart rate are secondary outcomes.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Music intervention as relieving effect of anxiety (about ten minutes)
Interventions/Control_2 No music
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Sixty patients with dental fear, whose age are 18 years old or greater, scheduled to undergo intravenous sedation for dental treatment with local anesthesia are enrolled in this study.
Key exclusion criteria The exclusion criteria are the patients less than 18 years old, and those who have been diagnosed with hearing impairment or arrhythmia or psychiatric diseases.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiaki Fujisawa
Organization Hokkaido University Hospital
Division name Department of Dental Anesthesiology
Zip code
Address Kita-14, Noshi-5, Kita-ku, Sapporo 060-8648 Japan
TEL 011-706-4397
Email fujitosi@den.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshiaki Fujisawa
Organization Hokkaido University Hospital
Division name Department of Dental Anesthesiology
Zip code
Address Kita-14, Noshi-5, Kita-ku, Sapporo 060-8648 Japan
TEL 011-706-4397
Homepage URL
Email fujitosi@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University Hospital
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
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
2017 Year 01 Month 04 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 Enrolling by invitation
Date of protocol fixation
2017 Year 04 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 08 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
2016 Year 11 Month 14 Day
Last modified on
2017 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028578

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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