Therapy on Perioperative Anxiety and Pain in Patients
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: eoperative Education + Intraoperative Music Therapy Arm, Preoperative Education Alone Arm.
- Кому может быть актуально
- Состояния в реестре: Music Therapy, Anxiety, Health Education. Базовые параметры: 18 лет — 40 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- 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
Effects of Preoperative Education Combined With Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients
Обзор
This study aims to explore the effects of preoperative education combined with intraoperative music therapy on perioperative anxiety and pain in patients undergoing elective cesarean section. The study subjects were patients scheduled for cesarean section under combined spinal - epidural anesthesia. A prospective study design with random grouping was adopted. Through systematic preoperative education and intraoperative music intervention, multi - dimensional evaluations were carried out to analyze the effects of preoperative education combined with intraoperative music therapy on the relief of perioperative anxiety, pain and shivering in patients, as well as its impact on postoperative recovery and nursing satisfaction.
Подробное описание
I. Research Methods A prospective randomized controlled trial design will be used. Eligible elective cesarean patients will be randomly assigned to an experimental group (preoperative education + intraoperative music therapy) or a control group (routine preoperative education only).
1. Preoperative Health Education Conducted by dedicated nurses 1 day before surgery, covering surgical procedures, precautions, anesthesia, and postoperative recovery. 2. Intraoperative Music Therapy Experimental group: Headphones fitted 1 hour preoperatively at 45-55 decibels, playing personalized or pre-screened music continuously during surgery and for 30 minutes postoperatively.
Intervention timing: Headphone adaptation and volume adjustment 1 hour preoperatively; continuous playback during surgery; 30-minute playback postoperatively to reduce anxiety and discomfort.
Executors: Preoperative education by specialized nurses; music therapy by trained operating room nurses to ensure equipment and volume stability. 3. Data Collection
Assessments at specified time points using standardized tools:
Anxiety: GAD-7 scale (preoperative, 6h, 12h, 24h postoperatively). Pain: VAS scale (preoperative, 6h, 12h, 24h postoperatively). Shivering index: Cold Shivering Index Scale (preoperative, before headphone use, at discharge from the operating room).
Postoperative complications: Wound infection, urinary retention, hemorrhage, heart failure, or pulmonary embolism.
Recovery indicators: Ambulation time, anal exhaust time, lactation time, hospital stay.
Satisfaction surveys: Nursing and anesthesia satisfaction via questionnaires 24h postoperatively. 4. Study Population
Inclusion criteria:
18-40 years old, singleton pregnancy, eligible for elective cesarean section. No severe pregnancy complications (e.g., preeclampsia, gestational diabetes). Able to provide informed consent and complete follow-ups.
Exclusion criteria:
Complications or diseases affecting study outcomes. Severe mental illness preventing protocol understanding. Refusal to participate or incomplete follow-ups. Allergy to music/headphones. II. Technical Route Literature review \& protocol design: Develop the study plan and obtain ethical approval.
Patient recruitment \& randomization: Enroll patients per criteria; use random number tables for grouping.
Intervention \& data recording: Standardized interventions by the research team; regular data verification.
Data analysis \& reporting: Statistical analysis to compare group differences; summarize findings and draft reports.
III. Feasibility Analysis Sample size: Estimated 64 patients per group (140 total, including 10% dropout rate) based on anxiety score differences and literature.
Ethical feasibility: Informed consent obtained; complies with ethical review requirements.
Technical feasibility: Hospital equipped with nursing tools (headphones, assessment scales) and a skilled team.
Resource feasibility: Reasonable budget and 10-month timeline ensure timely data collection, analysis, and reporting.
Вмешательства
- Другое eoperative Education + Intraoperative Music Therapy Arm
The experimental group implemented standardized preoperative education one day before the operation (covering knowledge such as the surgical procedure), headphone fitting one hour before the operation (with a volume of 45-55 decibels), and music therapy throughout the operation and for 30 minutes after the operation (parturients can choose personalized music). Full-time nurses were responsible for the preoperative education, and trained operating room nurses implemented the music therapy. Meanwh - Другое Preoperative Education Alone Arm
The control group received the same standardized preoperative education by full-time nurses one day before the operation, covering surgical procedures, precautions, anesthesia, and postoperative recovery. Data were collected at multiple time points using standardized tools, including anxiety scores (before and 6, 12, 24 h after surgery via GAD-7), pain scores (before and 6, 12, 24 h after via VAS), shivering index (before surgery, before wearing headphones, when leaving OR), postoperative compl
Первичные конечные точки
- anxiety score [Срок оценки: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively]
- pain score [Срок оценки: Baseline, up to 12 hours postoperatively, up to 24 hours postoperatively]
Вторичные конечные точки (2)
- shivering index [Срок оценки: baseline (before any intervention is initiated), Immediately After Birth,Perioperative]
- Record of postoperative complications [Срок оценки: Complications during hospitalization(assessed up to 5 days)]
Критерии участия
Inclusion Criteria： ASA grade I or II, aged 18-40 years female must be singleton pregnancy eligible
Критерии исключения
History of pregnancy-related complications severe pregnancy complications (e.g., preeclampsia, gestational diabetes mellitus) Severe mental illness
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
- Тройное слепое
- Основная цель
- Лечение
Центры проведения
Китай · 1 центр
- Na Li , MD — Ухань
Идентификаторы
NCT: NCT06970431 · MCHH_012