UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024830 |
|---|---|
| Receipt number | 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 | 2019/11/29 18:34:05 |
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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
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
fujitosi@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 08 | Day |
Last follow-up date
| 2018 | Year | 11 | Month | 19 | Day |
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
| 2019 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028578
