Evaluation of the Effect of Music During Nursing Care on the Confort of Patient Hospitalized in Intensive Care Unit During the Acute Phase of a Stroke (MELODHYA)

Nurses in Stroke Units and Neurovascular Intensive Care Units (USINV) provide care for patients who have experienced a stroke, a sudden and often devastating event that can result in motor, sensory, visual, cognitive, language, or swallowing impairments. Despite advances in stroke management, it remains the leading cause of acquired disability and the second leading cause of death in France, with 122,422 hospitalizations in 2022 and 773 at our institution in 2023. Acute stroke care guidelines recommend hospitalization in specialized neurovascular intensive care units (USINV), as this setting improves survival and recovery through specialized nursing care, close monitoring, and prevention of complications. However, the sudden onset of disability and the unfamiliar, often stressful hospital environment can lead to anxiety, fear, and a sense of helplessness among patients.

Providing comfort is a key nursing objective in this context. Kolcaba defines comfort as the experience of having fundamental needs for relief, well-being, and transcendence met in physical, psycho-spiritual, environmental, and sociocultural dimensions. Hygiene care, in particular, can contribute to comfort by ensuring cleanliness, minimizing pain, and improving self-image. The use of music during care has been proposed as a means to enhance comfort by positively influencing both physical and psychological states, as well as the care environment. Music can stimulate the senses, redirect attention, evoke pleasant memories, reduce stress, and provide a sense of control and identity for patients.

While music therapy-a specialized practice requiring trained professionals-has been studied in various fields, the use of music during routine care is distinct and has shown benefits in psychiatry, palliative care, and geriatrics, as well as during stressful procedures. In stroke rehabilitation, music has been explored for its effects on mood and recovery, but its use during the acute phase of stroke in USINV has not been systematically studied. An informal survey at our institution revealed that 78% of nurses and nursing assistants use music during care, particularly during hygiene procedures.

Our hypothesis is that incorporating music into hygiene care can improve patient comfort by addressing physical, psychological, and environmental needs. To assess comfort in a population that may have communication difficulties, we developed a visual comfort scale (0-5) using artificial intelligence-generated facial expressions. This scale was tested on 30 USINV patients and found to be accessible and easy to use, except for those with cognitive impairments or language barriers, who will be excluded from further study.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Other: SOC (Standard of care); Other: Use of music during nursing care

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stella BANNURA; Phone Number: +333144127963; Email: sbannura@ghpsj.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hôpital Paris Saint Joseph
    • Contact: Juliette COURTIADE MAHLER; Phone Number: +33144127963; Email: jcourtiade@ghpsj.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• French-speaking patient
• Aged 18 years or older
• Diagnosed with a stroke
• Hospitalized in a Neurovascular Intensive Care Unit (USINV)
• Requiring a complete bed bath by a nurse or nursing assistant
• Affiliated with a health insurance scheme
• Having provided free, informed, and explicit consent

Exclusion Criteria:

• Patient hospitalized for a reason other than stroke
• Patient with comprehension disorders (aphasia with impaired comprehension, cognitive disorders predating the stroke, confusion, non-French-speaking)
• Blind patient
• Patient under guardianship or curatorship
• Patient deprived of liberty or under legal protection (sauvegarde de justice)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of care	Other: SOC (Standard of care); Nursing care during hospitalization for stroke will be performed as the usual
Experimental: Music	Other: Use of music during nursing care; during hospitalization for stroke, nursing care will be performed while listening to music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Auto _ Evaluation of patient confort during nursing care	After the nursing care, Patient will evaluate their confort using a visual confort scale with 5 faces showing extreme discomfort (coded 1) to full confort (coded 5)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hetero evaluation of patient pain	nurses will evaluate patient pain after nursing care using the algoplus scale (0 indicating no pain at all, 30 maximum pain )	day 1

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: stroke; music; nursing care
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 778_MELODHYA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No