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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003826
Receipt No. R000004367
Scientific Title Randomized control trial of effect of aromatherapy on face-down related pain after vitreoretinal surgery.
Date of disclosure of the study information 2010/06/25
Last modified on 2010/12/27

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Basic information
Public title Randomized control trial of effect of aromatherapy on face-down related pain after vitreoretinal surgery.
Acronym Effect of aromatherapy on face-down related pain after vitreoretinal surgery.
Scientific Title Randomized control trial of effect of aromatherapy on face-down related pain after vitreoretinal surgery.
Scientific Title:Acronym Effect of aromatherapy on face-down related pain after vitreoretinal surgery.
Region
Japan

Condition
Condition Macular hole
Retinal detachment
Diabetic retinopathy
Classification by specialty
Ophthalmology Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to investigate the effect of aromatherapy on face-down related pain in after vitreoretinal surgery with gas injection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes pain in back, lumbar, shoulder, upper arm.
Key secondary outcomes sleep, satisfaction.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Aroma-treatment using essential oil with carrier oil.
Interventions/Control_2 Oil-treatment using only carrier oil.
Interventions/Control_3 control
Interventions/Control_4
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 Patient who was treated with vitreoretinal surgery with gas injection.
Key exclusion criteria Patients would be excluded if they had chronic pain due to other illness.
Patients who shows allergy to essential oil would also be excluded.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masakazu Nishigaki
Organization Graduate School of Medicine
The University of Tokyo
Division name Department of Adult Nursing, School of Health Sciences and Nursing
Zip code
Address 7-3-1 hongo, bunkyo-ku, Tokyo
TEL 03-5841-3609
Email

Public contact
Name of contact person
1st name
Middle name
Last name Minako Munesada
Organization Graduate School of Medicine, The University of Tokyo
Division name School of Health Sciences and Nursing
Zip code
Address 7-3-1 hongo, bunkyo-ku, Tokyo
TEL 03-5841-3609
Homepage URL
Email

Sponsor
Institute Graduate school of medicine, The University of Tokyo
Institute
Department

Funding Source
Organization none
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 東京大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 25 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
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
2010 Year 05 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 06 Month 25 Day
Last modified on
2010 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004367

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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