UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057038 |
|---|---|
| Receipt number | R000065191 |
| Scientific Title | Efficacy of Colored Bandages for Preventing Intravenous Line Self-Removal: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/02/15 |
| Last modified on | 2025/02/24 20:16:16 |
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Basic information
Public title
Efficacy of a Colored Bandage Intervention in Preventing Intravenous Line Self-Removal: A Randomized Controlled Trial
Acronym
Colored Bandage RCT for IV Line Removal Prevention
Scientific Title
Efficacy of Colored Bandages for Preventing Intravenous Line Self-Removal: A Randomized Controlled Trial
Scientific Title:Acronym
Colored Bandage for IV Self-Removal Prevention RCT (CB-IVSR RCT)
Region
| Japan |
Condition
Condition
Heart Failure Ischemic Heart Disease Angina Myocardial Infarction Arrhythmia eg Atrial Fibrillation Hypertensive Heart Disease Valvular Heart Disease Dementia Delirium Other Disorders with Cognitive Impairment
Classification by specialty
| Cardiology | Vascular surgery | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of protecting intravenous insertion sites with colored bandages on the prevention of intravenous line self-removal in hospitalized patients with cognitive impairment in a cardiology ward using a randomized controlled trial (RCT).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the frequency and severity of intravenous line self-removal using a 4-point Likert scale.
Key secondary outcomes
Evaluation of behavioral and psychological symptoms of dementia (BPSD) (Change in Neuropsychiatric Inventory Questionnaire: NPI-Q scores)
Assessment of delirium (Change in Intensive Care Delirium Screening Checklist: ICDSC scores)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
| Device,equipment |
Interventions/Control_1
Intervention group: The intravenous insertion site is protected using a colored bandage. Patients choose one preferred color from 12 available options, and the intravenous site is secured with the selected bandage.
Interventions/Control_2
Standard care is provided (no colored bandage is used). The intravenous insertion site is secured using a standard transparent film dressing.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
- Hospitalized patients aged 65 years or older.
- Patients who have been prescribed intravenous therapy.
- Patients with confirmed cognitive decline (Clinical Dementia Rating (CDR) score of 0.5 or higher).
Key exclusion criteria
- Patients whose primary diagnosis is a psychiatric disorder.
- Patients with a Japan Coma Scale (JCS) score of 10 or higher at the time of admission.
- Patients with bilateral upper limb paralysis.
- Patients under physical restraint at the time of admission.
- Patients with visual impairments (complete blindness or color blindness).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Uchida |
Organization
Graduate School of Health Sciences, Gunma University
Division name
Department of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, 371-8514, Japan
TEL
027-220-8931
yuchida@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Uchida |
Organization
Graduate School of Health Sciences, Gunma University
Division name
Department of Health Sciences
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, 371-8514, Japan
TEL
027-220-8931
Homepage URL
yuchida@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS) Grants-in-Aid for Scientific Research (KAKENHI), Category C
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Ethics Review Committee for Medical Research Involving Human Subjects
Address
3-39-22 Showa-machi, Maebashi, Gunma, 371-8511, Japan
Tel
027-220-7111
yuchida@gunma-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
| 2025 | Year | 02 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2027 | 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
| 2025 | Year | 02 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065191
