针对有剖腹产史的妇女,在铜T380A宫内节育器置入期间采用语言镇痛与标准技术进行疼痛控制的对比
2026年6月8日 更新者:Ahmed Samy aly ashour、Cairo University
既往剖宫产女性铜T380A宫内节育器置入期间语言镇痛与标准技术疼痛控制的比较:一项开放标签随机对照试验
铜质宫内节育器的置入通常伴有中度疼痛,这可能降低接受度和持续使用率。
已知未产妇和无阴道分娩史等因素会增加疼痛感知。
仅通过剖腹产分娩的女性构成一个特殊亚组,因为她们的宫颈未经历阴道扩张和宫颈重塑,使得置入在技术上更为困难且通常更疼痛。
该群体在既往镇痛试验中代表性不足,突显了一个重要的证据缺口。
研究概览
地位
完全的
条件
详细说明
铜质宫内节育器的置入常伴有中度疼痛,这可能降低其接受度和持续使用率。 已知未生育和无阴道分娩史等因素会增加疼痛感知。 仅通过剖宫产分娩的女性构成一个特殊亚群,因为她们的宫颈未经阴道扩张和宫颈重塑,使得置入在技术上更为困难且通常更疼痛。 该群体在既往镇痛试验中代表性不足,突显了一个重要的证据空白。
药物干预(非甾体抗炎药、阿片类药物、局部麻醉剂)的效果并不一致。 一项随机对照试验表明,在未生育女性中,使用平静声音、安抚和持续沟通的语言镇痛法,与曲马多对宫内节育器置入的镇痛效果相当。 迄今为止,尚无随机研究专门针对仅通过剖宫产分娩的女性。
研究类型
介入性
注册 (实际的)
88
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
-
Giza、埃及
- Algezeera Hospital
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
纳入标准:
年龄在18-45岁的女性。
- 希望使用铜T380A宫内节育器。
- 分娩史仅限于剖腹产,无阴道分娩史。
排除标准:
当前存在盆腔感染、宫颈炎或阴道炎。
- 子宫异常或肌瘤导致宫腔变形。
- 存在铜质宫内节育器植入禁忌症,且在植入前6-8小时内使用过任何镇痛药物。
- 怀孕或疑似怀孕。
- 严重痛经需要麻醉药物治疗。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 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:Verbal Analgesia
Participants randomized to the structured verbal analgesia group received a standardized supportive communication protocol throughout Copper T380A IUD insertion.
The provider used a calm, low-volume voice, steady pitch, slow rate of speech, guided breathing, and continuous reassurance.
The script was delivered at defined procedural steps, including before speculum insertion, during tenaculum application, during uterine sounding, during IUD insertion, and after completion of the procedure.
The technical insertion procedure was otherwise identical to the control group.
|
Structured verbal analgesia consisted of a scripted supportive communication protocol delivered by the provider throughout IUD insertion.
The protocol used calm tone, slow speech, guided breathing, reassurance, and positive procedural framing at predefined steps.
No additional pharmacologic analgesic intervention was given beyond the standard pre-procedure ibuprofen used in both groups.
|
|
有源比较器:Control - Standard Technique
Participants randomized to the standardized neutral communication group received brief procedural statements only during Copper T380A IUD insertion, such as "I am now placing the speculum," "I am sounding the uterus," "The IUD is being inserted," and "The procedure is complete."
The provider did not use additional reassurance, analgesic suggestion, guided breathing, or structured supportive phrasing.
The technical insertion procedure was otherwise identical to the verbal analgesia group.
|
Participants randomized to the standardized neutral communication group received brief procedural statements only during Copper T380A IUD insertion, such as "I am now placing the speculum," "I am sounding the uterus," "The IUD is being inserted," and "The procedure is complete."
The provider did not use additional reassurance, analgesic suggestion, guided breathing, or structured supportive phrasing.
The technical insertion procedure was otherwise identical to the verbal analgesia group.
|
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 |
|---|---|---|
|
Pain intensity at IUD release
大体时间:Immediately after IUD release in the uterine cavity, or immediately after the final attempted insertion step in failed cases.
|
Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.
Pain was recorded immediately after release of the Copper T380A IUD into the uterine cavity.
In failed insertion cases, pain at the final attempted insertion step was used as the prespecified primary-outcome substitute.
|
Immediately after IUD release in the uterine cavity, or immediately after the final attempted insertion step in failed cases.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
患者满意度
大体时间:在程序结束时,出院前
|
将在就诊结束时使用0-10分数字评定量表进行测量,其中0分代表完全不满意,10分代表完全满意
|
在程序结束时,出院前
|
|
Clinician-rated insertion difficulty
大体时间:Immediately after completion or termination of the IUD insertion procedure.
|
Insertion difficulty rated by the clinician using a 0-10 scale, where 0 indicates very easy insertion and 10 indicates the most difficult insertion.
|
Immediately after completion or termination of the IUD insertion procedure.
|
|
Pain after speculum insertion
大体时间:Immediately after speculum insertion.
|
Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.
|
Immediately after speculum insertion.
|
|
Pain after tenaculum application
大体时间:Immediately after tenaculum application.
|
Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.
|
Immediately after tenaculum application.
|
|
Pain after uterine sounding
大体时间:Immediately after uterine sounding.
|
Pain intensity measured using a 0-10 numerical rating scale, where 0 indicates no pain and 10 indicates the worst pain imaginable.
|
Immediately after uterine sounding.
|
|
Procedure time
大体时间:During the IUD insertion procedure.
|
Procedure time measured in minutes from speculum insertion to IUD placement and string trimming, or to termination of the final insertion attempt in failed cases.
|
During the IUD insertion procedure.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年10月10日
初级完成 (实际的)
2026年4月10日
研究完成 (实际的)
2026年5月10日
研究注册日期
首次提交
2025年9月24日
首先提交符合 QC 标准的
2026年1月3日
首次发布 (实际的)
2026年1月8日
研究记录更新
最后更新发布 (实际的)
2026年6月10日
上次提交的符合 QC 标准的更新
2026年6月8日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- verbal analgesia IUD
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
未定
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.