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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name