UMIN-CTR Clinical Trial

Basic information
Public title	Effect of aroma massage on quality of sleep in the palliative care ward: a randomized trial
Acronym	Effect of aroma massage on quality of sleep in the palliative care ward
Scientific Title	Effect of aroma massage on quality of sleep in the palliative care ward: a randomized trial
Scientific Title:Acronym	Effect of aroma massage on quality of sleep in the palliative care ward
Region	Japan

Condition
Condition	palliative care
Classification by specialty	Not applicable
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Effect of aroma massage on quality of sleep
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	quality of sleep evaluated by Richards Campbell Sleep Questionnaire on the day of aroma massage
Key secondary outcomes

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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	30-minute aroma massage on the limbs before bedtime
Interventions/Control_2	nontreatment
Interventions/Control_3
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who are hospitalized in the palliative care ward Subjects who have been in the ward for 3 days or more
Key exclusion criteria	Subjects who are not able to answer questionnaires Subjects who change sleep medications on the procedure day Subjects who had changed steroids < 7 days prior to study treatment Subjects with any known mass, inflammation, pain and open wound on the massage regions Prior treatment with aroma massage Subjects with prior hypersensitivity to aroma essential oil Subjects who are discharged within four days
Target sample size	74

Research contact person
Name of lead principal investigator	1st name Noriyuki Middle name Last name Kawabata
Organization	National Hospital Organization Kyoto medical center
Division name	Palliative care
Zip code	6128555
Address	1-1 Fukakusamukaihata-cho Fushimi-ku Kyoto city, Kyoto
TEL	075-641-9161
Email	off.kawabata@gmail.com

Public contact
Name of contact person	1st name Noriyuki Middle name Last name Kawabata
Organization	National Hospital Organization Kyoto Medical Center
Division name	Palliative care
Zip code	6128555
Address	1-1 Fukakusamukaihata-cho Fushimi-ku Kyoto city, Kyoto
TEL	075-641-9161
Homepage URL
Email	off.kawabata@gmail.com

Sponsor
Institute	National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization Kyoto Medical Center
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	National Hospital Organization Kyoto Medical Center
Address	1-1 Fukakusamukaihata-cho Fushimi-ku Kyoto city, Kyoto
Tel	075-641-9161
Email	off.kawabata@gmail.com

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	2018 Year 02 Month 01 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	74
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	2018 Year 01 Month 15 Day
Date of IRB	2018 Year 01 Month 15 Day
Anticipated trial start date	2018 Year 01 Month 15 Day
Last follow-up date	2019 Year 03 Month 25 Day
Date of closure to data entry	2019 Year 03 Month 25 Day
Date trial data considered complete	2019 Year 03 Month 25 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 02 Month 01 Day
Last modified on	2019 Year 08 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035518