Effect of Music on Pain, Anxiety, and Satisfaction During Outpatient Hysteroscopy in Postmenopausal Women: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
This randomized controlled trial evaluated whether calming instrumental music reduces pain and anxiety and improves satisfaction during outpatient hysteroscopy in postmenopausal women.
详细描述
This randomized controlled trial included postmenopausal women undergoing diagnostic outpatient hysteroscopy for postmenopausal bleeding or abnormal transvaginal ultrasound findings suggestive of intrauterine pathology. Participants were randomized 1:1 to receive calming instrumental music during the procedure or standard care without background music. The study assessed procedural pain, postprocedural pain, anxiety, patient satisfaction, operator-rated ease of hysteroscope insertion, procedure duration, intrauterine pathology detection, and adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal women undergoing diagnostic outpatient hysteroscopy for postmenopausal bleeding and/or abnormal transvaginal ultrasound findings suggestive of intrauterine pathology.
排除标准
- •Cervical pathology; previous cervical surgery that could interfere with hysteroscope passage; retroverted uterus; severe vaginal bleeding; known hearing impairment; psychiatric illness.
结局指标
主要结局
Intensity of pain
时间窗: 5 minutes
Pain intensity will be assessed by visual analog scale during the procedure. visual analog scale ranging from 0 to 10
次要结局
- anxiety during procedure(5 minutes)
研究者
Ahmed Samy aly ashour
professor
Cairo University