UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006596
Receipt number R000007804
Scientific Title The Effects of Hand and Lower Arm Massage Using Lavender Essential Oil on Autonomic Nervous Activity
Date of disclosure of the study information 2011/10/23
Last modified on 2017/04/23 12:39:13

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Basic information

Public title

The Effects of Hand and Lower Arm Massage Using Lavender Essential Oil on Autonomic Nervous Activity

Acronym

The Effects of Hand and Lower Arm Massage Using Lavender Essential Oil on Autonomic Nervous Activity

Scientific Title

The Effects of Hand and Lower Arm Massage Using Lavender Essential Oil on Autonomic Nervous Activity

Scientific Title:Acronym

The Effects of Hand and Lower Arm Massage Using Lavender Essential Oil on Autonomic Nervous Activity

Region

Japan


Condition

Condition

healthy male adults

Classification by specialty

Nursing Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to clarify the effects of hand and lower arm massage using lavender essential oil on autonomic nervous activity and surface skin temperature.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

heart rate variability (HF, LF/HF)
skin conductance response
surface skin temperature
subjective evaluation in an interview

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

massage with lavender essential oil group:
15-minute massage with essential oil

Interventions/Control_2

massage without lavender essential oil group:
15-minute massage without essential oil

Interventions/Control_3

control group:
15-minute rest

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

39 years-old >=

Gender

Male

Key inclusion criteria

1. subjects without heart disease
2. subjects without taking medicines
3. subjects who can understand the questionnaire
4. male subjects aged between 20 and 39 years old

Key exclusion criteria

subjects who cannot meet the above condition

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Michiko Hishinuma

Organization

St. Luke's International University, College of Nursing

Division name

Fundamentals of Nursing

Zip code


Address

10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan

TEL

03-3543-6391

Email

michiko-hishinuma@slcn.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ayaka Suzuki

Organization

St. Luke's International University, College of Nursing

Division name

Fundamentals of Nursing

Zip code


Address

10-1, Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan

TEL

03-3543-6391

Homepage URL


Email

ayaka-suzuki@slcn.ac.jp


Sponsor or person

Institute

St. Luke's International University

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


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

聖路加看護大学(現 聖路加国際大学)


Other administrative information

Date of disclosure of the study information

2011 Year 10 Month 23 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

2011 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 06 Month 01 Day

Last follow-up date

2011 Year 09 Month 01 Day

Date of closure to data entry

2011 Year 10 Month 01 Day

Date trial data considered complete

2011 Year 11 Month 01 Day

Date analysis concluded

2011 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 10 Month 23 Day

Last modified on

2017 Year 04 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007804


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name