UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003826
Receipt number 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 11:55:19

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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 or person

Institute

Graduate school of medicine, The University of Tokyo

Institute

Department

Personal name



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

Value
https://center6.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