UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056359 |
|---|---|
| Receipt number | R000062591 |
| Scientific Title | The Effect of Fan Therapy on Dyspnea in ICU Patients: A Crossover Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2024/12/04 17:12:18 |
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Basic information
Public title
The effect of Fan therapy in ICU
Acronym
The effect of Fan therapy in ICU
Scientific Title
The Effect of Fan Therapy on Dyspnea in ICU Patients: A Crossover Randomized Controlled Trial
Scientific Title:Acronym
The effect of Fan therapy in ICU
Region
| Japan |
Condition
Condition
Adult patients admitted to the Intensive Care Unit
Classification by specialty
| Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of fan therapy on symptoms of dyspnea, anxiety, and pain, as well as on sensations of comfort and discomfort in ICU patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference in changes measured using VAS before and after each intervention for dyspnea
Key secondary outcomes
The difference in changes measured using VAS before and after each intervention for anxiety, pain, and sensations of comfort and discomfort
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Expose FT to trigeminal region for 5 minutes.
Washout period should be at least 1 hour.
Interventions/Control_2
Control
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
Adult patients aged 18 and over admitted to the ICU
Patients capable of communicating in Japanese
Patients able to measure symptoms using VAS through writing or gestures
Key exclusion criteria
Patients admitted to the ICU due to diseases associated with consciousness disorders
Patients with a history of dementia
Patients with delirium
Patients with a history of mental illness
Patients in urgent and obvious life-threatening situations
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Mukoyama |
Organization
Fukuoka Red Cross Hospital
Division name
Intensive Care Unit
Zip code
8158555
Address
3-1-1,Okusu, Minami-ku, Fukuoka City, Japan
TEL
0570-03-1211
22351013@jrckicn.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Mukoyama |
Organization
Japanese Red Cross Kyushu International College of Nursing
Division name
Nursing Science Research Department,Graduate School of Nursing
Zip code
8114157
Address
1-1 Asti, Munakata-city,Fukuoka,Japan
TEL
0940-35-7001
Homepage URL
22351013@jrckicn.ac.jp
Sponsor or person
Institute
Japanese Red Cross Kyushu International College of Nursing
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Kyushu International College of Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Red Cross Kyushu International College of Nursing
Address
1-1 Asti, Munakata-city,Fukuoka,Japan
Tel
0940357001
22351013@jrckicn.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
福岡赤十字病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 05 | 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
25
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
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 20 | 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 | 12 | Month | 04 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062591
