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

NCT ID: NCT07313163

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Keywords

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stroke nursing care music

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of care

Group Type ACTIVE_COMPARATOR

SOC (Standard of care)

Intervention Type OTHER

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

Music

Group Type EXPERIMENTAL

Use of music during nursing care

Intervention Type OTHER

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

Interventions

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Use of music during nursing care

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

Intervention Type OTHER

SOC (Standard of care)

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Hôpital Saint-Joseph

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Paris Saint Joseph

Paris, , France

Site Status

Countries

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France

Central Contacts

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Stella BANNURA

Role: CONTACT

Phone: +333144127963

Email: [email protected]

Other Identifiers

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778_MELODHYA

Identifier Type: -

Identifier Source: org_study_id