Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:36 PM
Study NCT ID:
NCT07405593
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Head Up Position and Murottal Therapy in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This study is conducted as an open-label trial because the non-pharmacological interventions, including 30-degree head-up positioning and murottal therapy, are clearly observable and cannot be feasibly blinded to participants, care providers, or investigators.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants are assigned in parallel to an intervention group receiving 30-degree head-up positioning and murottal therapy or to a control group receiving standard care.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-04', 'studyFirstSubmitDate': '2026-01-26', 'studyFirstSubmitQcDate': '2026-02-04', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Baseline and after completion of the 3-day intervention', 'description': 'Change in systolic and diastolic blood pressure from baseline to after completion of the 3-day intervention.'}, {'measure': 'Pulse Rate', 'timeFrame': 'Baseline and after completion of the 3-day intervention', 'description': 'Change in pulse rate from baseline to after completion of the 3-day intervention.'}, {'measure': 'Respiratory Rate', 'timeFrame': 'Baseline and after completion of the 3-day intervention', 'description': 'Change in respiratory rate from baseline to after completion of the 3-day intervention'}, {'measure': 'Pain Degree', 'timeFrame': 'Baseline and after completion of the 3-day intervention', 'description': 'Change in pain score measured using the Critical-Care Pain Observation Tool (CPOT; range 0-8), where higher scores indicate more severe pain, from baseline to after completion of the 3-day intervention.'}, {'measure': 'Projectile Vomiting', 'timeFrame': 'Baseline and after completion of the 3-day intervention', 'description': 'Change in nausea and vomiting severity measured using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR; range 0-32), where higher scores indicate more severe symptoms, from baseline to after completion of the 3-day intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Head Up', 'Murottal Therapy'], 'conditions': ['Stroke']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://doi.org/10.1007/s12028-023-01752-y', 'label': 'Intracranial Pressure Monitoring and Management in Aneurysmal Subarachnoid Hemorrhage'}, {'url': 'https://doi.org/10.1055/s-0042-1758749', 'label': 'Adherence to Head-of-Bed Elevation in Traumatic Brain Injury: An Audit.'}, {'url': 'https://doi.org/10.1016/j.inat.2023.101886', 'label': 'Interdisciplinary Neurosurgery : Advanced Techniques and Case Management Position-dependent hemodynamic changes in neurosurgery patients : A narrative review.'}, {'url': 'https://doi.org/10.1186/s12884-024-06686-7', 'label': 'Nausea and vomiting in pregnancy ( NVP ) in Chinese pregnant women : a cross-sectional study'}, {'url': 'https://doi.org/10.3389/fneur.2023.1144564', 'label': 'Associations between computed tomography markers of cerebral small vessel disease and hemorrhagic transformation after intravenous thrombolysis in acute ischemic stroke patients.'}, {'url': 'https://doi.org/10.1007/s11910-025-01443-5', 'label': 'Blood Pressure Management Pre- and Post-Reperfusion in Acute Ischemic Stroke: Evidence and Insights from Recent Studies.'}, {'url': 'https://doi.org/10.1186/s12877-024-05127-6', 'label': 'Measuring pain intensity in older patients : a comparison of five scales.'}, {'url': 'https://doi.org/10.3389/ijph.2022.1604998', 'label': 'The Impact of Listening to , Reciting , or Memorizing the Quran on Physical and Mental Health of Muslims : Evidence From Systematic Review'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effects of a combination of a 30-degree head-up position and murottal therapy on physiological and symptom outcomes in stroke patients. The intervention is expected to influence blood pressure, pulse rate, respiratory rate, pain level, and the incidence of projectile vomiting. Stroke patients will receive standard care with the addition of the combined intervention. The results of this study may support non-pharmacological nursing interventions to improve patient comfort and clinical stability.', 'detailedDescription': 'Stroke patients often experience physiological instability and discomfort, including changes in blood pressure, pulse rate, respiratory rate, pain, and nausea or vomiting. Non-pharmacological nursing interventions are needed to support patient comfort and clinical stability during acute care. Head-up positioning and murottal therapy are commonly used supportive interventions in nursing practice, but evidence regarding their combined effects remains limited.\n\nThis study aims to evaluate the effects of a combination of a 30-degree head-up position and murottal therapy on blood pressure, pulse rate, respiratory rate, pain degree, and projectile vomiting in stroke patients. The study involves stroke patients receiving standard medical and nursing care, with the addition of the combined intervention as part of supportive nursing management.\n\nThe head-up position will be applied at a 30-degree angle, while murottal therapy will be delivered through 30-minute audio recitation during for 3 days. Physiological parameters and symptom outcomes will be measured before and after the intervention according to the study protocol. The findings of this study are expected to contribute evidence for the use of simple, non-pharmacological nursing interventions to improve comfort and physiological responses in stroke patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria :\n\n1. Patients with a medical diagnosis of stroke (hemorrhagic and non-hemorrhagic).\n2. Patients with systolic blood pressure above 150 mmHg.\n3. Somnolence (GCS ≥ 9).\n4. Muslim.\n5. Patients without hearing impairment.\n6. Willingness to participate and sign informed consent.\n\nExclusion criteria :\n\n1. Patients who are non-Muslim.\n2. Patients with decreased consciousness (GCS \\< 9).\n3. Patients with heart problems.\n4. Patients with psychiatric disorders.\n5. Patients receiving sedative therapy during the study.'}, 'identificationModule': {'nctId': 'NCT07405593', 'briefTitle': 'Head Up Position and Murottal Therapy in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Muhammadiyah Surakarta'}, 'officialTitle': 'The Combination Model of 30 Degree Head Up and Murottal Therapy on Blood Pressure, Pulse Rate, Respiratory Rate, Pain Degree, and Projectile Vomiting in Stroke Patients', 'orgStudyIdInfo': {'id': 'FDN-HU-MUROTTAL-STROKE-2026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination of 30-Degree Head-Up Positioning and Murottal Therapy', 'description': 'Participants receive a combination of 30-degree head-up positioning and murottal therapy in addition to standard nursing care during the intervention period.', 'interventionNames': ['Other: Combination of 30 Degree Head Up and Murottal Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care', 'description': "Participants receive standard nursing care according to the hospital's clinical protocol without the addition of head-up positioning or murottal therapy.", 'interventionNames': ['Other: Standard Care (in control arm)']}], 'interventions': [{'name': 'Combination of 30 Degree Head Up and Murottal Therapy', 'type': 'OTHER', 'description': 'Participants in this group received a combination of two non-pharmacological interventions during the study period. First, participants were positioned with their heads elevated at a 30-degree angle while lying in bed to support physiological stability, including monitoring of blood pressure, pulse rate, respiratory rate, pain level, and projectile vomiting. Second, participants listened to Quranic recitation (murottal therapy) via audio recording in a quiet environment. Both interventions were administered simultaneously. Intervention sessions lasted 30 minutes for 3 days (a consistent duration and frequency for all participants in this group). Outcomes such as vital signs, pain level, and episodes of severe vomiting were monitored before and after the intervention period.', 'armGroupLabels': ['Combination of 30-Degree Head-Up Positioning and Murottal Therapy']}, {'name': 'Standard Care (in control arm)', 'type': 'OTHER', 'description': 'Participants in this arm receive standard nursing care according to the hospital protocol without additional head-up positioning or murottal therapy. Standard care includes routine monitoring of vital signs, medication administration, and basic supportive nursing interventions.', 'armGroupLabels': ['Standard Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57571', 'city': 'Sukoharjo', 'state': 'Central Java', 'country': 'Indonesia', 'contacts': [{'name': 'Rosalia Dian Arsyta Putri, S.Kep.,Ns, M.Kep', 'role': 'CONTACT', 'email': 'rosalia.dian@ymail.com', 'phone': '02715722000', 'phoneExt': '844'}, {'name': 'Kristanti Indah Saraswati, S.Kep.,Ns, M.Kes', 'role': 'CONTACT', 'email': 'kristanti.indah@yahoo.com', 'phone': '02715722000', 'phoneExt': '837'}, {'name': 'Fila Diana Nurhayati, S.Kep.,Ns', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Rumah Sakit Indriati Solo Baru', 'geoPoint': {'lat': -6.7784, 'lon': 111.5334}}], 'centralContacts': [{'name': 'Fila Diana Nurhayati, S.Kep.,Ns', 'role': 'CONTACT', 'email': 'j218250001@student.ums.ac.id', 'phone': '+6281228527848'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Muhammadiyah Surakarta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Researcher', 'investigatorFullName': 'Fila Diana Nurhayati', 'investigatorAffiliation': 'Universitas Muhammadiyah Surakarta'}}}}