Tuning Out: The Effectiveness of Music on Pain and Anxiety in Intrauterine Device Insertion
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in self-reported anxiety (in the moment)
研究概览
简要总结
Although intrauterine devices (IUDs) are a highly effective contraceptive method, fear of pain during insertion is one barrier to use. A review of literature reveals little investigation of interventions for anxiety management during the procedure. Furthermore, evidence of non-pharmacological interventions for both anxiety and pain management is limited. Music has been shown to be effective at reducing anxiety and pain in a variety of contexts, however to the investigators' knowledge, its effectiveness for anxiety and pain relief during the IUD insertion procedure has not been formally examined. This study will therefore examine the effectiveness of listening to music on anxiety and pain during IUD insertion.
详细描述
The study is a randomized controlled trial of patients at least 16 years of age undergoing an IUD insertion. The experimental group will receive music, self-selected, with a music-playing device prior and during the procedure and the control group will receive standard care. Data for pain and anxiety will be collected prior to the procedure, and during, and after IUD insertion. In addition, a post-procedure questionnaire will be given to patients and providers to ask about satisfaction and acceptability of the intervention.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigators and statisticians performing final data analysis will be blinded to the group allocations
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Sufficient understanding of English to complete questionnaires
- •Women who will attend the clinic for an IUD insertion and accept to participate in the study
排除标准
- •Women with chronic pain
结局指标
主要结局
Change in self-reported anxiety (in the moment)
时间窗: Baseline, immediately after the procedure, immediately after uterine sounding
100 mm visual analog scale (VAS) measures anxiety reported by patients; values range 0-100 with higher values representing higher anxiety.
次要结局
- Change in anxiety(Baseline, immediately after the procedure)
- Complications related to IUD insertion procedure(Immediately after the procedure)
- Change in self-reported pain (in the moment)(Baseline, immediately after uterine sounding, immediately after insertion, immediately after the procedure)
研究者
Robin Lennox
Assistant Professor and Family Physician
McMaster University