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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024123
Receipt No. R000027777
Scientific Title The randomized controlled trial about the effects of aromatherapy on anxiety and abdominal discomfort during colonoscopy
Date of disclosure of the study information 2016/09/30
Last modified on 2017/09/07

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Basic information
Public title The randomized controlled trial about the effects of aromatherapy on anxiety and abdominal discomfort during colonoscopy
Acronym The randomized controlled trial about the effects of aromatherapy on colonoscopy
Scientific Title The randomized controlled trial about the effects of aromatherapy on anxiety and abdominal discomfort during colonoscopy
Scientific Title:Acronym The randomized controlled trial about the effects of aromatherapy on colonoscopy
Region
Japan

Condition
Condition Colonoscopy
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the effects of aromatherapy on anxiety and abdominal discomfort during colonoscopy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Abdominal discomfort during colonoscopy
Key secondary outcomes Anxiety during colonoscopy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration Institution is considered as a block.
Blocking
Concealment Numbered container method

Intervention
No. of arms 5
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 Lavender group: lavender oil
Interventions/Control_4 Grapefruit group: grapefruit oil
Interventions/Control_5 Osmanthus fragrans group: Osmanthus fragrans oil
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 Patients who take total colonoscopy in Self Defense Force Sendai Hospital
Key exclusion criteria 1 Patient who has contraindication diseases to antispastic (glaucoma, severe heart disease and prostatomegaly) or asthma
2 Patient who has allergy to foods or plants
3 Patient who could not complete their total colonoscopy
Target sample size 350

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
Email 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
Email sd37667hozu1334@yahoo.co.jp

Sponsor
Institute Self Defense Force Sendai Hospital
Institute
Department

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
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
2016 Year 09 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In the Osmanthus fragrans group, anxiety was significantly attenuated. The abdominal discomfort of patients who reported strong anxiety during colonoscopy was significantly attenuated in the grapefruit group and the Osmanthus fragrans group. 
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
2016 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 01 Month 10 Day
Date trial data considered complete
2017 Year 01 Month 18 Day
Date analysis concluded
2017 Year 01 Month 18 Day

Other
Other related information

Management information
Registered date
2016 Year 09 Month 21 Day
Last modified on
2017 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027777

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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