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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016882
Receipt No. R000019598
Scientific Title A RCT study of relieving effect of music sedation on psychological stress before entering dental outpatient operating room -Investigation with heart rate variability analysis-
Date of disclosure of the study information 2015/03/23
Last modified on 2015/03/23

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Basic information
Public title A RCT study of relieving effect of music sedation on psychological stress before entering dental outpatient operating room -Investigation with heart rate variability analysis-
Acronym A RCT study of relieving effect of music sedation on psychological stress before entering dental outpatient operating room
Scientific Title A RCT study of relieving effect of music sedation on psychological stress before entering dental outpatient operating room -Investigation with heart rate variability analysis-
Scientific Title:Acronym A RCT study of relieving effect of music sedation on psychological stress before entering dental outpatient operating room
Region
Japan

Condition
Condition impacted teeth
Classification by specialty
Anesthesiology Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate the effectiveness of music sedation from entering the hospital to just before entering the operating room 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 Heart rate variability was analyzed as the primary outcome indicator of autonomic nervous activity (the high-frequency component (HF) for parasympathetic nervous activity, the low-frequency component divided by HF (LF/HF) for sympathetic nervous activity)
Key secondary outcomes Coefficient of Variation of R-R intervals(CVRR), visual analog scale (VAS) as the indicator of subjective degree of stress and heart rate(HR) are secondary outcomes.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver Other
Interventions/Control_1 music sedation (relieving effect of anxiety)
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
60 years-old >=
Gender Male and Female
Key inclusion criteria Eighty-four patients whose age were between 18 and 60 scheduled to undergo intravenous sedation for the extraction of impacted teeth with local anesthesia were enrolled in this study.
Key exclusion criteria The exclusion criteria were that the patients less than 18 years old or more than 61 years old, and those who had been diagnosed with hearing impairment or arrhythmias or psychiatric diseases.
Target sample size 84

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, Nishi-5, Kita-ku, Sapporo 060-8648 Japan
TEL 011-706-8648
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, Nishi-5, Kita-ku, Sapporo 060-8648 Japan
TEL 011-706-4345
Homepage URL
Email fujitosi@den.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Grant - in - Aid for Scientific Research (c) (2), No. 26463179
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 北海道大学病院(北海道)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 23 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
Among patients in the dental anxiety block, LF/HF and VAS were significantly decreased in the music group after listening to music compared to the non-music group (Mann-Whitney U test P<0.05, respectively), while there were no significant changes in HF, CVRR and heart rate between the two groups. Among patients without dental anxiety, no significant differences were seen between music and non-music groups.
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 Completed
Date of protocol fixation
2013 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 22 Day
Last follow-up date
2014 Year 08 Month 11 Day
Date of closure to data entry
2015 Year 03 Month 23 Day
Date trial data considered complete
2015 Year 03 Month 23 Day
Date analysis concluded
2015 Year 03 Month 23 Day

Other
Other related information This registration was done after collecting data because we had forgotten to register in advance.

Management information
Registered date
2015 Year 03 Month 23 Day
Last modified on
2015 Year 03 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019598

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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