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Efficacy of a Colored Bandage Intervention in Preventing Intravenous Line Self-Removal: A Randomized Controlled Trial

Efficacy of Colored Bandages for Preventing Intravenous Line Self-Removal: A Randomized Controlled Trial - Colored Bandage for IV Self-Removal Prevention RCT (CB-IVSR RCT)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000057038
Enrollment
100
Registered
2025-02-15
Start date
2025-02-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 sel

Sponsors

Gunma University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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).

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
Evaluation of the frequency and severity of intravenous line self-removal using a 4-point Likert scale.

Secondary

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactYoko Uchida

Graduate School of Health Sciences, Gunma University Department of Health Sciences

yuchida@gunma-u.ac.jp027-220-8931

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026