AzTrials
AzTrials

CVA (Cerebrovascular Accident)NCT07899034

Music Therapy in Post-Stroke Patients: A Clinical Trial

A study testing Music therapy in people with CVA (Cerebrovascular Accident) and Ictus, run by Universidad de Granada at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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: What is the effect of music therapy on subjective sleep quality in stroke patients? What is the effect of music therapy on the subjective… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Music therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteSpain
Study dates
15 Jan 2025to Dec 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

  • Diagnosis or suspected diagnosis of stroke.
  • Admission to the Neurology Department of the Hospital Universitario Clínico San Cecilio (HUCSC).
  • Score ≥ 5 on the Canadian Neurological Scale.
  • Preserved cognitive function.
  • Glasgow Coma Scale score ≥ 14.

Who cannot join

  • Language impairment (aphasia).
  • Significant difficulties understanding the language.
  • Cognitive impairments affecting comprehension.
  • Acute psychiatric disorders and/or states of agitation.
  • Severe hearing impairment or profound deafness.
  • Diagnosis of obstructive sleep apnea.
Show all 9Show fewer
  • Restless legs syndrome.
  • Chronic obstructive pulmonary disease.
  • Narcolepsy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Raquel Rodríguez Blanque Associated Proffesor at University of Granada, Nursing contact

+34697958469

rarobladoc@ugr.es

Spain1 site, 1 recruiting
  • Hospital Universitario Clínico San Cecilio

    Granada, Granada, 18007

    Inmaculada Martín Villegas, Enfermería, +34634653484 ext. +34, inmaadra1@gmail.com

    Recruiting

Other trials in Spain

About this study

Official title: Effects of Music Therapy on Sleep Quality in Post-Stroke Patients: A Clinical Trial at the San Cecilio University Hospital

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:

  • What is the effect of music therapy on subjective sleep quality in stroke patients?
  • What is the effect of music therapy on the subjective perception of insomnia in stroke patients?
  • What is the effect of music therapy on levels of hospital anxiety and depression in stroke patients?
  • What is the level of satisfaction with the music therapy intervention?
Read more

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:

  • Complete some questionaries about sleep quality (Pittsburgh Sleep Quality Index), inmsonia (Insomnia Severity Index), anxiety and depression associated with hospitalization (Hospital Anxiety and Depression Scale) before and after de intervention.
  • Intervention group receive daily 60-minute music therapy sessions at night during their hospitalization, whenever possible.
  • Intervention gruop have to report their perceived level of satisfaction with the music therapy.
Read the detailed description
  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.

  • Study Design: A randomized clinical trial has been conducted at the Hospital Universitario Clínico San Cecilio (HUCSC) in Granada to investigate the impact of music therapy on subjective sleep quality, insomnia, and hospital anxiety and depression following stroke.
  • Sample Size: The sample size was calculated to detect a clinically significant difference of two points on the Pittsburgh Sleep Quality Index (PSQI), assuming an expected standard deviation of 3.02. Statistical power was set at 80%, with a significance level of 5% (type I error). A 10% dropout rate was also anticipated, resulting in a required sample size of 56 participants per group, with a 1:1 allocation ratio.
  • Intervention Phases:
  1. Pre-intervention: At the beginning of the study, baseline levels of anxiety and depression, subjective sleep quality, sleep latency, sleep duration and sleep efficiency, as well as the subjective perception of insomnia, were assessed.
  2. Before each session: The patient is prepared to receive the music therapy intervention by dimming the ambient lighting in the room and minimizing interruptions as much as possible.
  3. During each session: Music is played at a constant volume. The staff responsible for delivering the intervention adapts the experience according to the patient's needs. All personnel administering the intervention have received specific training to ensure its proper implementation.
  4. After each session: The following morning, the speakers are collected, and the patient's perception of the quality of their night's sleep is assessed.
  5. Post-intervention: Before hospital discharge, all baseline parameters are reassessed, and patient satisfaction with the intervention is evaluated.
  • Ethical Considerations: The study was approved by the Research Ethics Committee and conducted in accordance with Good Clinical Practice, ISO 14155, the Declaration of Helsinki, and the Oviedo Convention. Written informed consent was obtained from all participants, who were informed of their right to withdraw at any time. Data confidentiality and participant anonymity were ensured in accordance with Regulation (EU) 2016/679 and Spanish Law 41/2002, using restricted-access databases and alphanumeric participant codes.
Being tested
Music therapy
Keywords
Stroke, Music therapy, Sleep quality, Insomnia, Anxiety, Depression
Medical subject headings
Stroke, Sleep Initiation and Maintenance Disorders, Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Music therapyOther

    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.
Study groups in NCT07899034
Study groupRoleWhat they receive
Grupo intervención (receptor de musicoterapia)ExperimentalNot described
Receives: Other: Music therapy
Grupo control (no receptor de musicoterapia)No interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At study baseline and at the end of the study.

Secondary outcomes (6)
  1. 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.

    Measured: At study baseline and at the end of the study.

  2. 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.

    Measured: At study baseline and at the end of the study.

  3. 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.

    Measured: At study baseline

  4. 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.

    Measured: At study baseline

  5. 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.

    Measured: Immediately after the intervention

  6. 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

    Measured: Baseline, pre-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start15 Jan 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07899034
Sponsor's protocol ID
SICEIA-2024-003023
Status last verified
Oct 2026
First submitted
3 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Confidential data

Publications

  • Yang S, Yan X, Zhang Z, Gao W, Zhang T, Zhang W. Effects of music on post-stroke sleep disorders and treatment perspectives: review and narrative synthesis. Front Hum Neurosci. 2026 Jan 14;19:1710535. doi: 10.3389/fnhum.2025.1710535. eCollection 2025.

    PubMed 41613158
  • Serra Vila M, De Luis Molero VJ, Valls I Ballespí J. Evaluación de un programa de musicoterapia en una unidad de cuidados paliativos. La perspectiva de los cuidadores. Medicina Paliativa. 2016 Jul 1;23(3):129-40. doi:10.1016/j.medipa.2014.02.002

  • Alonso Modino D, Perestelo Perez L, Rosa Gonzalez FM, Toledo Chavarri A, Valcarcel Nazco C, Monton Alvarez FI. Quality of life and mental health in young strokes. Neurologia (Engl Ed). 2025 Apr;40(3):229-238. doi: 10.1016/j.nrleng.2025.03.003. Epub 2025 Mar 19.

    PubMed 40118171
  • Rodríguez López, A; Iglesias Mohedano, AM; Vales Montero, M; Gil Núñez, A. Código ictus. Manejo en urgencias del ictus en fase aguda. Medicine - Programa de Formación Médica Continuada Acreditado. 2023 Nov 1;13(90):5297-306. doi:10.1016/j.med.2023.10.019

  • Ding B, Yan J, Shan X, Deng M, Qian J, Du C, Zhang Y, Shen L, Ji F, Pan T. Effect of music intervention on preoperative anxiety, a randomised clinical study. Sci Rep. 2025 Oct 1;15(1):34261. doi: 10.1038/s41598-025-16413-7.

    PubMed 41034371
  • Li G, Yu L, Yang Y, Deng J, Shao L, Zeng C. Effects of Perioperative Music Therapy on Patients with Postoperative Pain and Anxiety: A Systematic Review and Meta-Analysis. J Integr Complement Med. 2024 Jan;30(1):37-46. doi: 10.1089/jicm.2022.0803. Epub 2023 Aug 30.

    PubMed 37646752
  • Dai RS, Wang TH, Chien SY, Tzeng YL. Dose-response analysis of music intervention for improving delirium in intensive care unit patients: A systematic review and meta-analysis. Nurs Crit Care. 2025 Sep;30(5):e13230. doi: 10.1111/nicc.13230. Epub 2025 Jan 24.

    PubMed 39854127
  • Fan LP, Quijano-Ruiz A, Wang C, Zhao HW, Wang DN, Wu HM, Liu L, Zhan YH, Zhou XB. Effects of personalized music listening on post-stroke cognitive impairment: A randomized controlled trial. Complement Ther Clin Pract. 2024 Nov;57:101885. doi: 10.1016/j.ctcp.2024.101885. Epub 2024 Jul 22.

    PubMed 39098085
  • Zhong K, An X, Kong Y. The effectiveness of five-element music therapy for post-stroke depression: A systematic review and meta-analysis. Heliyon. 2024 Feb 17;10(5):e26603. doi: 10.1016/j.heliyon.2024.e26603. eCollection 2024 Mar 15.

    PubMed 38444465
  • Gardener SH, Mukaetova-Ladinska EB, Perera NA. The Effect of Music Therapy on Psychological Outcomes for Neurological Conditions: A Systematic Review. Medicina (Kaunas). 2025 Sep 5;61(9):1611. doi: 10.3390/medicina61091611.

    PubMed 41011002
  • Jespersen KV, Pando-Naude V, Koenig J, Jennum P, Vuust P. Listening to music for insomnia in adults. Cochrane Database Syst Rev. 2022 Aug 24;8(8):CD010459. doi: 10.1002/14651858.CD010459.pub3.

    PubMed 36000763
  • Yang J, Lin A, Tan Q, Dou W, Wu J, Zhang Y, Lin H, Wei B, Huang J, Xie J. Development of insomnia in patients with stroke: A systematic review and meta-analysis. PLoS One. 2024 Apr 10;19(4):e0297941. doi: 10.1371/journal.pone.0297941. eCollection 2024.

    PubMed 38598535
  • Kang J, Cho YS, Lee M, Yun S, Jeong YJ, Won YH, Hong J, Kim S. Effects of nonpharmacological interventions on sleep improvement and delirium prevention in critically ill patients: A systematic review and meta-analysis. Aust Crit Care. 2023 Jul;36(4):640-649. doi: 10.1016/j.aucc.2022.04.006. Epub 2022 Jun 17.

    PubMed 35718628
  • Pan EY, Wang W. Elements of music that work to improve sleep, a narrative review. Front Sleep. 2025 Dec 2;4:1707162. doi: 10.3389/frsle.2025.1707162. eCollection 2025.

    PubMed 41425167
  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

Questions about this trial

What is this clinical trial studying?

A study testing Music therapy in people with CVA (Cerebrovascular Accident) and Ictus, run by Universidad de Granada at 1 site in Spain.

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 5 inclusion and 9 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 Oct 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 Spain. 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 Raquel Rodríguez Blanque Associated Proffesor at University of Granada, Nursing (+34697958469, rarobladoc@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh Sleep Quality Index (PSQI) (time frame: At study baseline and at the end of the study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07899034, which also lists 31 linked publications.

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 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in