UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053791 |
|---|---|
| Receipt number | R000061394 |
| Scientific Title | Pilot study to create a comfortable treatment space using an airflow system with a simulated window |
| Date of disclosure of the study information | 2024/03/06 |
| Last modified on | 2024/03/06 15:49:34 |
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Basic information
Public title
Pilot study to create a comfortable treatment space using an airflow system with a simulated window
Acronym
Pilot study to create a comfortable treatment space using an airflow system with a simulated window
Scientific Title
Pilot study to create a comfortable treatment space using an airflow system with a simulated window
Scientific Title:Acronym
Pilot study to create a comfortable treatment space using an airflow system with a simulated window
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to provide exploratory insights into the impact of a comfortable treatment and recuperation space on patient symptoms and emotions and the factors that contribute to optimal personalization of the space.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of ESAS-J score change before and after 1 day of installation of air blowing system with pseudo window
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The intensity of symptoms will be evaluated by the Edmonton Symptom Assessment System Japanese version (ESAS-r-J) at any given time on the day before the installation of the air blowing system with pseudo windows (Day 1). In addition, "sense of release, healing, enjoyment, and satisfaction" will be evaluated by Numerical Rating Scale (NRS). In addition, autonomic nervous system function will be measured by having subjects wear a smartwatch on their wrists and a Sleep Scan (Paramount Bed, Japan) will be placed under their bedding. Twenty-four hours after the initial evaluation (Day 2), a ventilation system with a pseudo-window will be installed. The patients will be evaluated by ESAS-r-J and NRS at the time of installation of the system (Day 2) and 24 hours after installation (Day 3), and their autonomic nervous system function will be measured by TAS9 view. The smartwatch and sleep scan will be worn or installed continuously from any time on the day before the installation of the airflow system with a pseudo-window (Day 1) to the end of the intervention (Day 3). The airflow from the ventilation system will be directed to the subject's face, and the air volume will be set to moderate in principle, but the subject can adjust it according to his/her own preferences. In principle, the video images will be played in accordance with the time of day using the application equipped with the pseudo-window, but if desired and with the cooperation of family members, etc., the video images can be played at home or any other desired location.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients over 18 years old
Cancer patients who are hospitalized for more than 7 days
Those who are hospitalized in an environment that does not allow them to enjoy the view from the window.
Those who are able to answer the questionnaire in writing or orally.
Key exclusion criteria
Patients under the age of 18
Non-cancer patients
Those who are hospitalized for less than 7 days
Those who are hospitalized in an environment where they can enjoy the scenery from the window.
Those with cognitive decline to the extent that they are unable to respond to the questionnaire.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Okamoto |
Organization
Ashiya Municipal Hospital
Division name
Department of Pharmacy
Zip code
659-8502
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
TEL
0797-31-2156
okamoysh@phs.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Niki |
Organization
Ashiya Municipal Hospital
Division name
Department of Pharmacy
Zip code
659-8502
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
TEL
0797-31-2156
Homepage URL
k-niki@phs.osaka-u.ac.jp
Sponsor or person
Institute
Ashiya Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ashiya Municipal Hospital Ethics Review Committee
Address
39-1, Asahigaoka-cho, Ashiya, Hyogo
Tel
0797-31-2156
k-niki@phs.osaka-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 03 | Month | 06 | Day |
Last modified on
| 2024 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061394
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
