Music as a Nonpharmacologic Approach to Pain Control With Intrauterine Device Placement
The intervention of this study is the addition of patient-selected music during IUD insertion procedure. Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure. Both control and music groups will otherwise undergo the same standard protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes.
Subjects in both control and intervention groups will undergo the same assessment of pain during IUD insertion using the 100-mm visual analog scale (VAS). This will be administered at 8 points during the procedure. All subjects will also answer the same 5-question satisfaction survey following IUD insertion. Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study.
研究概览
详细说明
This is a prospective, two-center, randomized controlled trial evaluating whether music reduces pain and improves satisfaction during IUD insertion. Computer-generated randomization assignments will allocate subjects to either music or standard protocol groups. 40 music and 40 control designations will be allocated to both sites, and all designations will be block-stratified into 10 blocks, each containing 4 controls and 4 intervention (music) subjects. This will ensure there are close to equal numbers of subjects in both groups if recruitment is halted before the minimum of 80 patients are enrolled. Assignments are available in a read-only document accessible by all co-investigators at the time of enrollment and randomization.
Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal. Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Both control and music groups will otherwise undergo the same standard anticipatory guidance and protocol for IUD insertion in an outpatient clinic setting. Total participation is predicted to last approximately 30 minutes, as is standard for an appointment for IUD insertion. Study subjects will not interact with other participants.
Patients in both control and intervention groups will undergo intrauterine device (IUD) insertion. Pain will be assessed using a 100-mm visual analog scale (VAS) at 8 points during the procedure, including: (1) anticipated pain, (2) baseline pain prior to IUD insertion, (3) after speculum placement, (4) on tenaculum application, (5) on uterine sounding, (6) at IUD insertion, (7) after speculum removal, and (8) 5 minutes following the procedure. Patients will also answer a brief 5-question satisfaction survey following IUD insertion. Pain scores will be measured and compared between music and control groups to assess the primary and secondary outcomes of this study.
VAS scores will be recorded by the attending physician or co-investigator, as they will reliably note when each step of the procedure occurs and pain should be assessed. They will present the 100mm visual analog scale (VAS) to the patient at each of the 8 points of the procedure, and the patient will mark their pain score. Scores will be measured and documented by a single co-investigator to eliminate bias or differences in measurement.
VAS scores will be analyzed separately for each of the 8 distinct points described during the IUD insertion procedure. Differences between the intervention (music) and control groups will be assessed using a 0.05 level Wilcoxon ranksum test. A significant difference in pain will be noted if at least a 20 mm difference in VAS pain score exists between the two groups at any point of the procedure when VAS score is collected.
The aim of this study is to determine if music, chosen by the patient and played during IUD insertion, leads to lower pain scores and improved patient satisfaction with the procedure.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10019
- Mount Sinai West
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New York、New York、美国、10003
- Mount Sinai Beth Israel
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Nulliparous adult females age 18 years or older (nulliparous is defined as no prior pregnancies greater than or equal to 20 weeks of gestation)
- English-speaking patients
- Undergoing insertion of a copper or levonorgestrel intrauterine device
- Willing to comply with all study procedures
Exclusion Criteria:
- Non-English speaking patients
- Patients with a support person in the room during IUD insertion
- Patients desiring a paracervical block for analgesia
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Music Intervention group
Subjects randomized to the music group will choose 10 songs, which will be played during the procedure, from the time of positioning through completion of IUD insertion and speculum removal.
Participants will otherwise undergo standard protocol for IUD insertion in an outpatient clinic setting.
Total participation is predicted to last approximately 30 minutes.
|
Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred.
Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure.
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无干预:Control group
Participants to undergo same standard protocol for IUD insertion in an outpatient clinic setting.
No music will be played during the procedure.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
100-mm visual analog scale (VAS)
大体时间:Day 1, at time of IUD insertion
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100-mm VAS total scale from 1-100 with higher score indicating more pain
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Day 1, at time of IUD insertion
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
100-mm visual analog scale (VAS)
大体时间:Day 1, baseline prior to IUD insertion
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100-mm VAS total scale from 1-100 with higher score indicating more pain
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Day 1, baseline prior to IUD insertion
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100-mm visual analog scale (VAS)
大体时间:Day 1, after speculum placement
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100-mm VAS total scale from 1-100 with higher score indicating more pain
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Day 1, after speculum placement
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100-mm visual analog scale (VAS)
大体时间:Day 1, on tenaculum application
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100-mm VAS total scale from 1-100 with higher score indicating more pain
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Day 1, on tenaculum application
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100-mm visual analog scale (VAS)
大体时间:Day 1, on uterine sounding
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100-mm VAS total scale from 1-100 with higher score indicating more pain
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Day 1, on uterine sounding
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100-mm visual analog scale (VAS)
大体时间:Day 1, after speculum removal
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100-mm VAS total scale from 1-100 with higher score indicating more pain
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Day 1, after speculum removal
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100-mm visual analog scale (VAS)
大体时间:Day 1, 5 minutes following the procedure
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100-mm VAS total scale from 1-100 with higher score indicating more pain
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Day 1, 5 minutes following the procedure
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Patient Satisfaction Survey
大体时间:Day 1, post procedure at 30 minutes
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Patient Satisfaction Survey consists of 5-question administered post-procedure.
Full scale from 1 to 5, with higher score indicating higher satisfaction.
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Day 1, post procedure at 30 minutes
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合作者和调查者
调查人员
- 首席研究员:Neha R Bhardwaj, MD、Icahn School of Medicine at Mount Sinai
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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