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Набор скоро начнётся NCT07454434

The Effect of Music on Anxiety Levels and Sleep Quality in Patients Who Have a Myocardial Infarction

Без фазы С лечением Sleep Quality Anxiety

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Music intervention.
Кому может быть актуально
Состояния в реестре: Sleep Quality, Anxiety. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Music on Anxiety Levels and Sleep Quality During the First Night in the Coronary Care Unit in Patients Who Have a Myocardial Infarction

Обзор

Music therapy is a non-invasive method with no side effects and can be administered independently by a nurse. Nevertheless, it should be noted that music therapy can be discontinued if any adverse effects are experienced by patients during the research process. After completing the music listening session, eye masks and earplugs, which are effective in reducing sleep problems in patients, will be applied from 11:00 p.m. to 7:00 a.m. All patients will be asked to complete the DAÖ at 10:00 PM and 10:30 PM. The RCUÖ will be requested to be completed by all patients between 8:00 AM and 9:00 AM the following morning.

Подробное описание

Control Group: Patients in the control group will receive routine treatment and care in the coronary care unit (CCU). Patients presenting with MI are admitted to the coronary care unit from the emergency department and the cardiology outpatient clinic. In patients admitted to the CCU, preparations are made for percutaneous coronary intervention (PCI) and admission procedures by evaluating electrocardiography (ECG), blood parameters (CK-MB and troponin), and pain symptoms. These preparations include obtaining the patient's medical history and necessary consent, establishing an intravenous line, measuring and monitoring vital signs, and recording the ECG and adding it to the file. In patients undergoing PCI, the femoral sheath is not removed for four hours due to the heparin infusion administered. After the femoral sheath is removed by the physician, pressure dressing is applied to the procedure site and a sandbag is placed to control bleeding for six hours. During this time, patients are placed in a supine position. Depending on the clinical condition and hematological values of the patients, they are monitored in the coronary care unit for one or two days and then transferred to the cardiology clinic.

In the coronary care unit, in order to control patients' anxiety levels or improve their sleep quality, after care, treatment, and daily blood sampling procedures are completed, lighting is reduced after midnight, except in emergencies, to facilitate patients' transition to sleep. However, eye masks or earplugs are not routinely used for patients.

Study Group: In addition to the clinic's routine treatment and care practices, patients in the study group will listen to music for 30 minutes at 10:00 p.m. on their first night in the coronary care unit using wireless Bluetooth headphones (JBL TUNE 520BT, Harman International Industries, USA) provided by the researcher (MY). The volume of the music will be adjusted according to the patient's preference. Patients in the study will listen to the CD "Music and Health Series: Tümata-Receptive \& Meditative Uşşak Mode" prepared by the Turkish Music Research and Promotion Association (TÜMATA), which is said to provide calmness and relaxation and has previously been shown to be effective in reducing preoperative anxiety. The Uşşak mode has a tempo of 60-80 beats per minute and provides relaxation by calming the heart. The CD used contains an instrumental piece without lyrics in the Uşşak mode, which fits the definition of "sedative music". The piece features improvisation based on rhythm and the sound of water, performed with the ney, rebab, çeng, ud, dombra, and rubab. In addition to evoking a sense of peace and tranquility, the Uşşak mode supports feelings of self-confidence and determination thanks to its hidden pentatonic structure . The Uşşak mode is reported to give individuals a desire to laugh, a feeling of relaxation, joy, strength, and heroism; it is also reported to be beneficial for sleep and rest processes. Its effect is said to be particularly pronounced from dawn to noon, at sunset, and on Thursdays; it is also said to be beneficial in alleviating pain associated with heart and foot disorders and gout. Furthermore, it is known as one of the oldest modes used to express deep love and mystical feelings .

Вмешательства

  • Другое Music intervention
    Music therapy is a non-invasive method with no side effects and can be administered independently by a nurse. However, it should be noted that music therapy may be discontinued if any adverse effects are observed in patients during the research process. After completing the music therapy, eye masks and earplugs , which are effective in reducing sleep problems in patients, will be applied from 11:00 p.m. to 7:00 a.m.

Первичные конечные точки

  • Participants' anxiety levels [Срок оценки: Within the State Anxiety Scale framework, the study group will receive 30 minutes of music at 22:00 on their first night in the Coronary Intensive Care Unit, alongside routine care, via wireless Bluetooth headphones under researcher supervision.]
Вторичные конечные точки (1)
  • Sleep Quality [Срок оценки: The Richard-Campbell Sleep Questionnaire will be administered to all patients between 08:00 and 09:00 on the morning following their first night of hospitalization.]

Критерии участия

Критерии включения

  • Admitted to the coronary care unit with a diagnosis of MI,
  • Aged 18 years or older,
  • Conscious, oriented, and cooperative,
  • Able to read and understand Turkish,
  • Agreeing to participate in the study,
  • Having no physical condition that would prevent listening to music,
  • Having no diagnosis of hearing loss,
  • Not using a hearing aid,
  • Having no diagnosis of anxiety disorder,
  • Not diagnosed with a sleep disorder,
  • Not taking medication for anxiety or sleep disorders,
  • Without mental illness,
  • With a State Anxiety Scale (SAS) total score of 60 or below,
  • Who agree to participate in the study (by signing the Informed Consent Form) will be included.

Критерии исключения

  • Admitted to the coronary care unit (CCU) for reasons other than MI diagnosis,
  • Under 18 years of age,
  • Unconscious, disoriented, and uncooperative,
  • Unable to read and understand Turkish,
  • Refusing to participate in the study,
  • Having a physical condition that prevents listening to music,
  • Diagnosed with hearing loss,
  • Using a hearing aid,
  • Diagnosed with an anxiety disorder or taking medication for anxiety,
  • Diagnosed with a sleep disorder or taking medication for a sleep disorder,
  • With a mental disorder,
  • With a State Anxiety Scale (SAS) total score of 60 or above,
  • Patients who do not agree to participate in the study (who do not sign the Informed Consent Form) will not be included in the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07454434 · MersinUniversit · Gülay Altun Ugras

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗