UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037709 |
|---|---|
| Receipt number | R000042960 |
| Scientific Title | The offect of Aromatherapy massage for the patients with Schizophrenia |
| Date of disclosure of the study information | 2019/08/18 |
| Last modified on | 2019/08/17 02:36:27 |
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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
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
kumazawa.taeko.mg@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Simofusa Psychiatric hospital
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
National Hospital Organization Simofusa Psychiatric hospital
Address
578 , Hetacho , Midori-ku , Chiba-si , Chiba
Tel
043-291-1221
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042960
