UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016882 |
|---|---|
| Receipt number | 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 19:20:51 |
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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
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
fujitosi@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019598
| 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 |
