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临床试验/CTRI/2022/04/041947
CTRI/2022/04/041947已完成不适用

Effect of Music Therapy on Pain and Anxiety Levels in Women undergoing Office Hysteroscopy

AIIMS New Delhi1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年2月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
1.The effect of background music as a complimentary factor in relieving pain

研究概览

简要总结

Hysteroscopy plays a crucial role in the evaluation of the uterine cavity in women with abnormal uterine bleeding and infertility. Advancements in both the procedure and the instrument has enabled its use in the office context. As an office procedure, it gives comparable results to inpatient hysteroscopy, with the advantages of lower costs and avoidance of anaesthetic risks. The main disadvantage of the use of office hysteroscopy is the pain experienced by the patient, there is still paucity of data on effective technique to reduce pain. Also, any surgical procedure be it diagnostic or operative causes some level of anxiety in the patients. This study aims to evaluate the effect of music therapy during office hysteroscopy in improving pain and anxiety experienced by the patient  during office hysteroscopy. It also aims to study the satisfaction rate among doctors and patients with or without music therapy.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
25.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • •Patients with post-menopausal bleeding
  • •Abnormal uterine bleeding
  • •Patients with primary infertility
  • •Secondary infertility.

排除标准

  • •Patients with hearing impairment
  • •Previous cervical procedures like conization, Manchester Fothergills procedure
  • •Cervical stenosis
  • •Retroverted uterus
  • •Patients with anxiety disorder on medication.

结局指标

主要结局

1.The effect of background music as a complimentary factor in relieving pain

时间窗: 1. At the end of the procedure for each patient | 2. Overall outcome will be assesed at the end of 6 months

2.The effect of background music on relieving anxiety in patients undergoing office hysteroscopy.

时间窗: 1. At the end of the procedure for each patient | 2. Overall outcome will be assesed at the end of 6 months

次要结局

  • Time taken per procedure by the surgeonsin the presence of background music during office hysteroscopy procedures(2 months and 6 months)

研究者

发起方
AIIMS New Delhi
申办方类型
Government medical college

研究点 (1)

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