UMIN-CTR Clinical Trial

Basic information
Public title	The offect of Aromatherapy massage for the patients with Schizophrenia
Acronym	The offect of Aromatherapy massage for the patients with Schizophrenia
Scientific Title	The offect of Aromatherapy massage for the patients with Schizophrenia
Scientific Title:Acronym	The offect of Aromatherapy massage for the patients with Schizophrenia
Region	Japan

Condition
Condition	Schizophrenia
Classification by specialty	Psychiatry Nursing
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To reveal the Aromatherapy massage for the patients with Schizophrenia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Scale of feeling of relaxation Salivary amylase
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Aromatherapy massage
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients with Schizophrenia during hospitalization
Key exclusion criteria	The people with Allergic reaction by patch test
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Taeko Middle name Last name Kumazawa
Organization	National Hospital Organization Simofusa Psychiatric hospital
Division name	Nursing division
Zip code	266-0007
Address	578 , Hetacho , Midori-ku , Chiba-si , Chiba
TEL	043-291-1221
Email	kumazawa.taeko.mg@mail.hosp.go.jp

Public contact
Name of contact person	1st name Taeko Middle name Last name Kumazawa
Organization	National Hospital Organization Simofusa Psychiatric hospital
Division name	Nursing division
Zip code	266-0007
Address	578 , Hetacho , Midori-ku , Chiba-si , Chiba
TEL	043-291-1221
Homepage URL
Email	kumazawa.taeko.mg@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization Simofusa Psychiatric hospital
Institute
Department

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	National Hospital Organization Simofusa Psychiatric hospital
Address	578 , Hetacho , Midori-ku , Chiba-si , Chiba
Tel	043-291-1221
Email	kumazawa.taeko.mg@mail.hosp.go.jp

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	独立行政法人国立病院機構下総精神医療センター（千葉県）

Other administrative information
Date of disclosure of the study information	2019 Year 08 Month 18 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	2020 Year 03 Month 31 Day
Baseline Characteristics	Schizophrenia
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2019 Year 08 Month 13 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 13 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 08 Month 17 Day
Last modified on	2019 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042960