UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized controlled trial about the effects of aromatherapy on anxiety and abdominal discomfort during colonoscopy
Title of the study (Brief title)	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	Hideaki Hozumi
Organization	Self Defense Force Sendai Hospital
Division name	Internal Medicine
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	Hideaki Hozumi
Organization	Self Defense Force Sendai Hospital
Division name	Internal Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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