NCT06783920尚未招募不适用
EFFECT of MUSIC in Reducing Pain and Anxiety During Copper T380A Intrauterine Device Insertion in Nulliparous Women.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- pain during IUD insertion
研究概览
简要总结
The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women
详细描述
The aim is to evaluate the role of music in reducing pain and anxiety during copper IUD insertion in nulliparous women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous women aged over 18 years of age requesting a copper IUD for contraception who had a negative pregnancy test.
排除标准
- •a prior pregnancy greater than 20 weeks of duration
- •currently pregnant or were pregnant within 6 weeks of study entry
- •had a prior attempted or successful IUD insertion
- •had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD active vaginitis or cervicitis
- •undiagnosed abnormal uterine bleeding
- •pelvic inflammatory disease within the last 3 months
- •fibroids or other uterine abnormalities distorting the uterine cavity
研究组 & 干预措施
music group
Experimental
干预措施: music (Procedure)
no-music group
Placebo Comparator
干预措施: no music (Procedure)
结局指标
主要结局
pain during IUD insertion
时间窗: 5 minutes
pain will be measured by the 10 cm visual analog scale where 0 denotes no pain, and 10 denotes worst pain felt
次要结局
- anxiety during IUD insertion(5 minutes)
研究者
Ahmed Samy aly ashour
professor
Cairo University
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