UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009729
Receipt No. 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

* 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
Institute Kameda Medical Center Makuhari
Institute
Department

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
URL(English) https://upload.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


Contact us.