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Набор скоро начнётся NCT07476820

Anxiety and Physiological Responses in Ambulatory Surgery

Без фазы С лечением Anxiety Heart Rate Variability (HRV) Heart Rate Blood Pressure

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: Self-selected Music intervention, Fixed-music Music intervention.
Кому может быть актуально
Состояния в реестре: Anxiety, Heart Rate Variability (HRV), Heart Rate, Blood Pressure. 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 →

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Официальное название

Subjective Anxiety and Physiological Parameters in First-Time Ambulatory Surgery Patients

Обзор

This study aims to investigate the effects of music intervention on subjective anxiety and physiological indicators, including heart rate, blood pressure, and heart rate variability, in first-time ambulatory surgery patients, and to compare the differential effects between self-selected and standardized music interventions.

Подробное описание

This study aims to investigate the effects of music intervention on subjective anxiety and physiological parameters in first-time ambulatory surgery patients. The physiological parameters include heart rate, blood pressure, and heart rate variability (HRV), while subjective anxiety will be assessed using standardized measurement scales. The study also compares the differential effects of two types of music interventions-self-selected music and standardized classical music-on patients' anxiety and physiological parameters. During the intervention, all music playback conditions, including timing, environment, and use of headphones, will be kept consistent to ensure comparability between groups. The results of this study will provide evidence on the clinical applicability of music as a non-pharmacological strategy for anxiety management.

Вмешательства

  • Поведенческое Self-selected Music intervention
    This study adopted a randomized controlled trial (RCT) design. Eligible outpatients undergoing surgery for the first time were recruited and randomly assigned, using block randomization, into three groups: a self-selected music group, a fixed-music group, and a control group. During the intervention period, participants in the music groups listened to music (self-selected or fixed) for 10 minutes in the preoperative nursing waiting area, while the control group received routine care. Data were c
  • Поведенческое Fixed-music Music intervention
    Participants assigned to the standardized music group will listen to pre-selected classical music provided by the research team, aimed at promoting relaxation and focused attention. The selected music maintains a stable tempo of 60-70 beats per minute and is delivered at a sound level below 60 dB to ensure comfort and safety. Music will be administered via headphones under standardized conditions. The timing, duration, listening environment, and outcome measurement procedures will be identical t

Первичные конечные точки

  • Subjective Anxiety: Visual Analog Scale for Anxiety (VAS-A) [Срок оценки: Baseline (T0, pre-intervention); during the 10-minute intervention (T1); immediately after surgery in the postoperative recovery period (T2)]]
  • Subjective Anxiety: State Anxiety Inventory (STAI-S) [Срок оценки: Baseline (T0, pre-intervention); immediately after surgery in the postoperative recovery period (T2)]]
  • Subjective Anxiety: Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Срок оценки: Baseline (T0, pre-intervention)]
Вторичные конечные точки (4)
  • Heart Rate Variability (HRV) [Срок оценки: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)]
  • Systolic Blood Pressure [Срок оценки: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)]
  • Diastolic Blood Pressure [Срок оценки: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)]
  • Heart Rate [Срок оценки: Baseline (T0, pre-intervention) and during the 10-minute intervention (T1)]

Критерии участия

Критерии включения

  • Be at least 18 years old.
  • Undergo outpatient surgery for the first time.
  • Be mentally clear and able to communicate in Chinese and complete the questionnaire.
  • Agree to wear physiological monitoring devices and sign the consent form.

Критерии исключения

  • Hearing impairment or the need to use a hearing aid.
  • Currently using sleeping pills/sedatives or having a mental illness.
  • Severe cardiovascular disease or having an implanted pacemaker.
  • Diseases that affect autonomic nervous system function.

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
Двойное слепое
Основная цель
Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07476820 · 115011

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗