An interventional study of Music therapy in CVA (Cerebrovascular Accident), Ictus and Stroke Acute, sponsored by Universidad de Granada. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Universidad de Granada · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to learn if music therapy works to optimizate sleep quality in patients who have suffered a stroke. The main questions it aims to answer are:
Researchers will compare an intervention group consisting of patients who will undergo music therapy with a control group of participants receiving standard care without music therapy sessions.
Participants will:
1. Background Stroke is a major cause of mortality and disability worldwide. Post-stroke patients frequently experience sleep disturbances, which are exacerbated during hospitalization and may negatively affect recovery. Anxiety and depression are also common after stroke.
Music therapy is a promising non-pharmacological intervention, although evidence of its effects on sleep quality in post-stroke patients remains limited. Therefore, this clinical trial aims to assess the effects of music therapy on sleep quality in patients with recent stroke at the Hospital Universitario Clínico San Cecilio (HUCSC) in Granada.
Intervention Phases:
7,448 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 84 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Universidad de Granada is the lead sponsor of 245 studies on the registry; 42 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other: Music therapy
Intervention Characteristics: * Duration: each music therapy session will last 60 minutes * Setting: the sessions will be administered during at night shift in the Neurology Department of the Hospital Universitario Clínico San Cecilio (HUCSC). * Frequency: daily sessions will be administered during the participant's hospitalization, whenever the participant's clinical condition allows. * Type of music: the selected music will consist of slow rhythms (60-80 bpm) and soft sounds, avoiding abrupt changes. Pieces in lower pitches and with flowing melodies have been shown to facilitate the transition to sleep, while avoiding elements that may stimulate the listener, such as lyrics or pronounced rythms. * Method of delivery: low-intensity speakers will be used in dimly lit environments to expose participants to the music therapy intervention.
Pittsburgh Sleep Quality Index (PSQI)
This is a validated, self-administered instrument consisting of 19 questions distributed across seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. The total score ranges from 0 to 21, with scores greater than 5 indicating poor sleep quality. The PSQI has previously been used in studies involving patients diagnosed with stroke.
Time frame: At study baseline and at the end of the study.
Insomnia Severity Index (ISI)
This validated scale allows the assessment of insomnia severity and its functional impact. It consists of 7 items assessing difficulties in falling sleep and maintaining sleep, satisfaction with sleep, the impact on daily activities, and the degree of concern associated with sleep difficulties. Each item is scored on a scale from 0 to 4, with a total score ranging from 0 to 28. Based on the total score, the following severity levels are established: * From 0 to 7: absence of clincally significant insomnia. * From 8 to 14: subclinical insomnia. * From 15 to 21: moderate insomnia. * From 22 to 28: severe insomnia.
Time frame: At study baseline and at the end of the study.
Hospital Anxiety and Depression Scale (HADS)
This scale consist of 14 items, organized in two subscales: * Anxiety subscale (HADS-A): identifies symptoms associated with anxiety. * Depression subscale (HADS-D): assesses symptoms associated with depression. Each item is scored on a scale from 0 to 3 points, where 0 represents the absence of symptoms and 3 represents the greatest symptom severity. Thus, each subescale can achieve a total score ranging from 0 to 21 points. * From 0 to 7: normal emotional state. * From 8 to 10: mild anxiety or depression. * From 11 to 14: moderate anxiety or depression. * From 15 to 21: severe anxiety or depression.
Time frame: At study baseline and at the end of the study.
Glasgow Coma Scale (GCS)
This scale is used to measure the level of consciousness and brain injury. It consists of three components: * Eye opening: scored on a scale of 1 to 4 points, where 1 corresponds to no eye opening anda 4 to spontaneous eye opening. * Verbal response: scored from 1 to 5, with 1 indicating no verbal response and 5 indicatin an oriented and appropiate response. * Motor response: scored from 1 to 6, where 1 indicates no motor response and 6 indicates the ability to follow commands. The sum of the three components yields a total score ranging from 3 to 15 points. Scores of 8 or lower indicate a severe coma and require immediate intervention.
Time frame: At study baseline
Canadian Neurological Scale (CNS)
Neurological status in patients with stroke is assessed using this scale. It is structured into three domains, although only two of them were analyzed in this study: * Mental function: * Level of consciousness: distinguishing between alert and drowsy patients, as well as assessing their level of orientation in time and space. * Language: assessed as normal, with impaired expression, or with impaired comprehension. * Motor functions: * Patients without comprehension impairment: facial function and motor function in the upper limb (proximal and distal) and lower limbs are assessed. * Patients with comprehension impairment: the same motor areas are assessed, with evaluations performed periodically accordign to established protocols, generally every four hours.
Time frame: At study baseline
Patient satisfaction scale
It consists of a five-item questionnaire assessing the perceived benefits of music therapy, the feeling of relaxation experienced during the sessions, the suitability of the setting in which the intervention was delivered, the appropriateness of the number and duration of the sessions, and whether participants wpuld recommend this intervention.
Time frame: Immediately after the intervention
Sociodemographic data and clinical variables
An ad hoc instrument is administered to collect sociodemographic data (age and sex). Clinical variables are obtained from the electronic medical record available throug the Diraya system
Time frame: Baseline, pre-intervention
Plan to share: No — Confidential data
Started Jan 2025 (actual). Primary completion is estimated for Dec 2027, 35 months after the start.
Of 2,859 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 35 months is above that.
Counting every sponsor, half of 2,988 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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