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临床试验/NCT05514236
NCT05514236已完成不适用

Effect of Virtual Reality and Music Therapy on Pain Relief in Outpatient Hysteroscopy: A Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2022年9月21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
210
试验地点
1
主要终点
The change of the pain score of virtual reality therapy compared to control group (no intervention) in outpatient hysteroscopy.

研究概览

简要总结

Outpatient hysteroscopy is an essential diagnostic procedure for abnormal uterine bleeding, such as menorrhagia or postmenopausal bleeding, to evaluate any intrauterine pathologies. It also serves as a therapeutic procedure such as removal of fibroids, polyps or intrauterine devices.However, the most common reason for procedure failure is pain.

On such occasions, the procedure has to be re-arranged in the operation theatre under regional or general anesthesia. Therefore, improvement in pain management can reduce patients' health care experience, patients' anesthetic and procedural risks, decrease healthcare costs, and reduce inconvenience to patients.

This randomized controlled trial aims at evaluating the effectiveness of non-pharmacological interventions (virtual reality and music therapy) in pain management during hysteroscopy. It can hopefully provide more clinical data to explore the role of non-pharmacological techniques in outpatient hysteroscopy pain control, hence help improve our participants' experience in outpatient hysteroscopy.

详细描述

Introduction:

Outpatient hysteroscopy is an essential diagnostic procedure for abnormal uterine bleeding, such as menorrhagia or postmenopausal bleeding, to evaluate any intrauterine pathologies. It also serves as a therapeutic procedure such as myomectomy, polypectomy and removal of lost intrauterine devices. However, the most common reason for procedure failure is pain. The frequently reported causes of pain include manipulation of the cervix with the tenaculum, uterine distension, application of hysteroscopic instruments, and performance of hysteroscopic procedures such as endometrial sampling. Some factors further enhance the degree of pain experienced, such as nulliparity, post-menopausal status, cervical stenosis and high anxiety level. On such occasions, the procedure has to be re-arranged in the operation theatre under regional or general anesthesia. Therefore, improvement in pain management can reduce patients' health care experience, patients' anesthetic and procedural risks, decrease healthcare costs, and reduce inconvenience to patients.

The major pain relief modalities include pharmacological and non-pharmacological techniques. The common analgesic agents used are non-steroid anti-inflammatory drugs (NSAID) and opioids; use of which is limited by their contraindications and side effects, such as deranged renal function and nausea. Non-pharmacological options are therefore a safer alternative. Some studies show that music and virtual reality are effective pain control for out-patient hysteroscopy. To date, there was only one published randomized controlled trial regarding the effectiveness of virtual reality in pain management. The study was limited by small sample size and conducted in only one center.

This randomized controlled trial aims at evaluating the effectiveness of non-pharmacological interventions (virtual reality and music therapy) in pain management during hysteroscopy. It can hopefully provide more clinical data to explore the role of non-pharmacological techniques in outpatient hysteroscopy pain control, hence help improve our participants' experience in outpatient hysteroscopy.

Objective:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants scheduled for outpatient hysteroscopy in Prince of Wales Hospital
  • Participants who are willing to give written consent to participate in the study

排除标准

  • Participants who have hearing or visual deficits
  • Participants who cannot understand written Chinese
  • Participants refuse to participate in the study

结局指标

主要结局

The change of the pain score of virtual reality therapy compared to control group (no intervention) in outpatient hysteroscopy.

时间窗: Passage of hysteroscope through cervical internal os and during the assessment of uterine cavity of each participant. The study will be up to 1.5 years.

The change of the pain score of virtual reality therapy at different time-point during outpatient hysteroscopy, compared to control group (no intervention). Pain score from 0 to 10, with 0 being no pain and 10 the most severe pain.

The change of the pain score of music therapy compared to control group (no intervention) in outpatient hysteroscopy.

时间窗: Passage of hysteroscope through cervical internal os and during the assessment of uterine cavity of each participant. The study will be up to 1.5 years.

The change of the pain score of music therapy at different time-point during outpatient hysteroscopy, compared to control group (no intervention). Pain score from 0 to 10, with 0 being no pain and 10 the most severe pain.

次要结局

未报告次要终点

研究者

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

YIP Ka Man

Principal Investigator

Chinese University of Hong Kong

研究点 (1)

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