UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024123 |
|---|---|
| Receipt number | 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 18:16:20 |
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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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027777
