StrokeMELODHYANCT07313163
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
A study testing Use of music during nursing care in people with Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Use of music during nursing care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 11 Feb 2026to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Paris Saint Joseph
Paris
Juliette COURTIADE MAHLER, +33144127963, jcourtiade@ghpsj.fr
About this study
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.
Read more
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.
- Conditions
- Stroke
- Being tested
- Use of music during nursing care, SOC (Standard of care)
- Keywords
- stroke, nursing care, music
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of music during nursing careOther
during hospitalization for stroke, nursing care will be performed while listening to music
SOC (Standard of care)Other
Nursing care during hospitalization for stroke will be performed as the usual
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Not described Receives: Other: SOC (Standard of care) |
| Music | Experimental | Not described Receives: Other: Use of music during nursing care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Secondary outcomes (1)
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 )
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start11 Feb 2026
- Primary completionFeb 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313163
- Sponsor's protocol ID
- 778_MELODHYA
- Acronym
- MELODHYA
- Status last verified
- Feb 2026
- First submitted
- 17 Dec 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07313163
- Acronym / sponsor ID
- MELODHYA / 778_MELODHYA
- Conditions
- Stroke
- Keywords
- stroke, nursing care, music
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 31 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Other: SOC (Standard of care) |
| Music | Experimental | Other: Use of music during nursing care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of music during nursing careduring hospitalization for stroke, nursing care will be performed while listening to music | Other | Music |
| SOC (Standard of care)Nursing care during hospitalization for stroke will be performed as the usual | Other | Standard of care |
Primary outcome
Auto _ Evaluation of patient confort during nursing care
Time frame: Day 1
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)
1 secondary outcome
Hetero evaluation of patient pain
Time frame: day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of music during nursing care in people with Stroke, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stella BANNURA (+333144127963, sbannura@ghpsj.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auto _ Evaluation of patient confort during nursing care (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.