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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07313163
Acronym
MELODHYA
Enrollment
102
Registered
2025-12-31
Start date
2026-02-11
Completion date
2027-07-01
Last updated
2026-02-27

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

Conditions

Stroke

Keywords

stroke, nursing care, music

Brief summary

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.

Interventions

OTHERUse of music during nursing care

during hospitalization for stroke, nursing care will be performed while listening to music

Nursing care during hospitalization for stroke will be performed as the usual

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Auto _ Evaluation of patient confort during nursing careDay 1After 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)

Secondary

MeasureTime frameDescription
Hetero evaluation of patient painday 1nurses will evaluate patient pain after nursing care using the algoplus scale (0 indicating no pain at all, 30 maximum pain )

Countries

France

Contacts

CONTACTStella BANNURA
sbannura@ghpsj.fr+333144127963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026