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

UMIN ID: UMIN000057038

Registered date:15/02/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: 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
• Date of first enrollment: 2025/02/15
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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.
Standard care is provided (no colored bandage is used). The intravenous insertion site is secured using a standard transparent film dressing.

Outcome(s)

• Primary Outcome: Evaluation of the frequency and severity of intravenous line self-removal using a 4-point Likert scale.
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 65years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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).

Related Information

• Primary Sponsor: Gunma University
• Source(s) of Monetary Support: Japan Society for the Promotion of Science (JSPS) Grants-in-Aid for Scientific Research (KAKENHI), Category C