UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048717 |
|---|---|
| Receipt number | R000055445 |
| Scientific Title | The effects of environment in facilities for the elderly on the mental state of elderly residents: The effects of a colorful and soothing environment |
| Date of disclosure of the study information | 2022/08/22 |
| Last modified on | 2025/02/26 13:46:01 |
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Basic information
Public title
The effects of environment in facilities for the elderly on the mental state of elderly residents: The effects of a colorful and soothing environment
Acronym
The effects of environment in facilities for the elderly on the mental state of elderly residents: The effects of a colorful and soothing environment
Scientific Title
The effects of environment in facilities for the elderly on the mental state of elderly residents: The effects of a colorful and soothing environment
Scientific Title:Acronym
The effects of environment in facilities for the elderly on the mental state of elderly residents: The effects of a colorful and soothing environment
Region
| Japan |
Condition
Condition
healthy adult and dementia adult
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to show the effects produced by environment on people living in facilities for the elderly, after four spaces were set up with artwork, flowers, background music (BGM), and aromatherapy fragrances.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1)POMS2(Profile of Mood States Second Edition)
Key secondary outcomes
(2)WHO-QOL26 (3)GDS15(Geriatric depression scale15) (4)SD(Sematic Differential) method (5)free descriptions of four spaces.
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
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Environments with artwork, flowers, BGM, and aromatherapy were set up within these facilities for the elderly for 6 months. Surveys of the elderly people living in these facilities were conducted before the start of the study and 2 weeks, 3 months, 6 months, and 9 months after the start of the study.
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
People who had no to mild cognitive impairment, the ability to hold a conversation, who received a full explanation of the study and were able to understand its content, and who gave their own written consent.
Key exclusion criteria
People with visual hallucinations, severe hearing loss, severe visual impairment, moderate to severe cognitive dysfunction, unstable physical condition, or adverse reactions to scents or smells.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Etsuko |
| Middle name | |
| Last name | Kawakubo |
Organization
Josai international University
Division name
Faculty of Nursing
Zip code
283-8555
Address
1 Gumyo,Togane-shi,Chiba
TEL
0475-55-7041
kawakubo@jiu.ac.jp
Public contact
Name of contact person
| 1st name | Etsuko |
| Middle name | |
| Last name | Kawakubo |
Organization
Josai international University
Division name
Faculty of Nursing
Zip code
283-8555
Address
1 Gumyo,Togane-shi,Chiba
TEL
0475-55-7041
Homepage URL
kawakubo@jiu.ac.jp
Sponsor or person
Institute
Josai international University
Institute
Department
Personal name
Funding Source
Organization
SOYOKAZE CO., Ltd former Unimat Retirement Community Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Gunma University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committees of Josai International Unversity
Address
1 Gumyo,Togane-shi,Chiba
Tel
0475557832
research-c@jiu.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
株式会社ユニマット リタイアメント・コミュニティの高齢者施設（シニアマンションおよび有料老人ホーム）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 22 | 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
105
Results
QOL: No significant difference. GDS: No significant difference. POMS: With valid responses from 60 people, the CB (confusion-bewilderment) subscale was significantly different between the second week and third month (P<0.05). Although there were no significant differences in AH (anger-hostility), CB (confusion-bewilderment), DD (depression-dejection), FI (fatigue-inertia), TA (tension-anxiety), or TMD (total mood disturbance), there was a W shape.
Results date posted
| 2025 | Year | 02 | Month | 26 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
In the works
Date of the first journal publication of results
Baseline Characteristics
Of 105 people who consented to the study, 82 were involved after excluding those who withdrew (mean age 85.7 plus or minus 6.2 years). They included 41 people (50%) without dementia, 25 (30%) with dementia independence level I, 3 (4%) with IIa, 11 (13%) with IIb, and 2 (2%) with IIIa. Comparison of interventions.
Participant flow
Four environments were set up simultaneously in the homes: (1) modern artworks displayed, (2) flowers displayed, (3) selected music (BGM) played in the lobby and dining room, and (4) aromatherapy fragrance diffusion.
Adverse events
no
Outcome measures
WHO-QOL 26, GDS-15, POMS, and an environmental image scale (SD method). Questionnaire
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 18 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 04 | Day |
Date trial data considered complete
| 2023 | Year | 09 | Month | 09 | Day |
Date analysis concluded
| 2023 | Year | 09 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055445
