UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024124 |
|---|---|
| Receipt number | R000027778 |
| Scientific Title | The randomized controlled trial about the effect of aromatherapy on gastrointestinal movement during gastrointestinal endoscopy |
| Date of disclosure of the study information | 2016/09/30 |
| Last modified on | 2018/03/26 21:51:21 |
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Basic information
Public title
The randomized controlled trial about the effect of aromatherapy on gastrointestinal movement during gastrointestinal endoscopy
Acronym
The randomized controlled trial about the effect of aromatherapy on gastrointestinal movement during gastrointestinal endoscopy
Scientific Title
The randomized controlled trial about the effect of aromatherapy on gastrointestinal movement during gastrointestinal endoscopy
Scientific Title:Acronym
The randomized controlled trial about the effect of aromatherapy on gastrointestinal movement during gastrointestinal endoscopy
Region
| Japan |
Condition
Condition
Gastrointestinal endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effect of aromatherapy on gastrointestinal movement during gastrointestinal endoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Niwa classification
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Control group: no aromatherapy
Interventions/Control_2
Vehicle group: essential-oil-less vapor
Interventions/Control_3
Peppermint group: peppermint oil
Interventions/Control_4
Grapefruit group: grapefruit oil
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
Key inclusion criteria
Patient who take gastrointestinal endoscopy in Self Defense Force Sendai Hospital
Key exclusion criteria
Patient who could not complete their gastrointestinal endoscopy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideaki Hozumi |
Organization
Self Defense Force Sendai Hospital
Division name
Internal medicine
Zip code
Address
1-1 Minami-no-Medate Miyagino-ku, Sendai, Miyagi, 983-8580, Japan
TEL
022-231-1111
sd37667hozu1334@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Hozumi |
Organization
Self Defense Force Sendai Hospital
Division name
Internal medicine
Zip code
Address
1-1 Minami-no-Medate Miyagino-ku, Sendai, Miyagi, 983-8580, Japan
TEL
022-231-1111
Homepage URL
sd37667hozu1334@yahoo.co.jp
Sponsor or person
Institute
Self Defense Force Sendai Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
自衛隊仙台病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 30 | 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
The odor of grapefruit oil did not attenuate the gastrointestinal movement during gastrointestinal endoscopy.
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
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 08 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 08 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 21 | Day |
Last modified on
| 2018 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027778
| 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 |
