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临床试验/NCT04232930
NCT04232930已完成不适用

The Use of Music in Reducing Pain During Outpatient Hysteroscopy: Prospective Randomized Trial

Pamela Youde Nethersole Eastern Hospital1 个研究点 分布在 1 个国家目标入组 107 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
107
试验地点
1
主要终点
Intensity of pain

研究概览

简要总结

The aim of this study is to demonstrate the value of music in outpatient hysteroscopy on patients' level of pain and satisfaction. This may have a role in our daily practice in providing a better patient care in outpatient hysteroscopy.

详细描述

Outpatient hysteroscopy is nowadays a commonly used procedure in Gynaecology in order to evaluate the uterine cavity and to diagnose different intrauterine diseases. It is a safe, convenient and cost-effective procedure in aiding the management of abnormal uterine bleeding. However, outpatient hysteroscopy can be associated with significant pain which would have impact on the woman's satisfaction and pain is one of the most common reasons for failure of the procedure.

Listening to music could be an easy and non-invasive way to reduce pain. A meta-analysis conducted on the effects of music on pain revealed that music interventions had statistically significant effects in decreasing pain on 0-10 pain scales. Researches on this topic in gynaecological office procedures, however, showed variation in the results. Some showed no positive effect of music on patient's level of pain, anxiety or satisfaction of patient or doctor for office hysteroscopy and colposcopy. On the other hand, some studies showed a positive effect of the use of music with a reduction of pain and anxiety during office hysteroscopy.

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

盲法说明

This is not a blinded study as both the participant and the care provider will be able to listen to the music if the subject is assigned into the music group.

入排标准

性别
Female
接受健康志愿者

入选标准

  • indication for hysteroscopy (abnormal uterine bleeding, abnormal findings on ultrasound, and infertility)
  • signed informed consent
  • ability to read Chinese or English.

排除标准

  • hearing impairment
  • known anatomical abnormalities which would make performing the procedure more difficult
  • use of premedication for cervical ripening

结局指标

主要结局

Intensity of pain

时间窗: Actual pain experienced during hysteroscopy

Pain measured using visual analog scale (VAS) on a 0-10 scale, with 0 indicating "no pain" and 10 indicating "worst pain possible".

次要结局

  • Diastolic blood pressure(Diastolic blood pressure during hysteroscopy)
  • Heart rate(Heart rate during hysteroscopy)
  • Systolic blood pressure(Systolic blood pressure during hysteroscopy)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Law Ho Ying

Resident, Department of Obstetrics and Gynaecology

Pamela Youde Nethersole Eastern Hospital

研究点 (1)

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