UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009729
Receipt number R000011402
Scientific Title Effects of listening to music and essential oil inhalation on screening CT colonography: A prospective randomized controlled trial.
Date of disclosure of the study information 2013/01/08
Last modified on 2014/10/12 14:58:29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of listening to music and essential oil inhalation on screening CT colonography: A prospective randomized controlled trial.

Acronym

Effects of listening to music and essential oil inhalation on screening CT colonography

Scientific Title

Effects of listening to music and essential oil inhalation on screening CT colonography: A prospective randomized controlled trial.

Scientific Title:Acronym

Effects of listening to music and essential oil inhalation on screening CT colonography

Region

Japan


Condition

Condition

Healthy individual

Classification by specialty

Gastroenterology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of effecacy of listening to soft music or inhaling Citrus bergamia aroma on screening CT colonography

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Objective data on burden of CT colonography were collected using blood pressure and heart rate before and after procedures.

Key secondary outcomes

Subjective data on perceived burden of CT colonography were collected using visual analogue scale (VAS) and a questionnaire.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

combined music and aroma group

Interventions/Control_2

music group

Interventions/Control_3

aroma group

Interventions/Control_4

control group

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Healthy individual.
2) Major functions of organs of the subjects are in a good condition.
3) Aged 20 years or older.
4) Signed informed consent forms are obtained by the patients.

Key exclusion criteria

1) Previous colorectal surgery.
2) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
3) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
4) Possibility of pregnancy.
5) Patients with psychological conditions that contraindicate colonoscopy or make them irrelevant to participate in the trial.
6) Claustrophobia.
7) Deafness.
8) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.

Target sample size

224


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichi Nagata M.D PhD

Organization

Kameda Medical Center Makuhari

Division name

Department of Gastroenterology

Zip code


Address

1-3 CD2, Nakase, Mihama-ku, Chiba, 261-8501, Japan

TEL

043-296-2711

Email

nagata_mgh@live.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koichi Nagata M.D PhD

Organization

Kameda Medical Center Makuhari

Division name

Department of Gastroenterology

Zip code


Address

1-3 CD2, Nakase, Mihama-ku, Chiba, 261-8501, Japan

TEL

043-296-2711

Homepage URL


Email

nagata_mgh@live.jp


Sponsor or person

Institute

Kameda Medical Center Makuhari

Institute

Department

Personal name



Funding Source

Organization

Kameda Medical Center Makuhari

Organization

Division

Category of Funding Organization

Self funding

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

亀田メディカルセンター幕張(千葉県)


Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ejradiology.com/article/S0720-048X(14)00459-8/abstract

Number of participants that the trial has enrolled


Results

Music does not decrease patients' perceived pain or acceptance during CTC.
Aromatherapy does not affect patients' perceived pain or experience during CTC.
Music and aroma had little effect on vital signs during CTC.
More participants who listened to music requested music during the next CTC.
More participants who inhaled aroma requested aroma during the next CTC.

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

Main results already published

Date of protocol fixation

2012 Year 04 Month 15 Day

Date of IRB


Anticipated trial start date

2012 Year 06 Month 15 Day

Last follow-up date

2013 Year 05 Month 31 Day

Date of closure to data entry

2013 Year 06 Month 15 Day

Date trial data considered complete

2013 Year 06 Month 30 Day

Date analysis concluded

2013 Year 07 Month 10 Day


Other

Other related information



Management information

Registered date

2013 Year 01 Month 08 Day

Last modified on

2014 Year 10 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011402


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name