跳至主要内容
临床试验/NCT05751811
NCT05751811招募中不适用

Effect of Virtual Reality and Music Therapy on Pain Relief in Outpatient Hysteroscopic Operations: 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: 2023年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
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 can serve as a diagnostic procedure to evaluate for abnormal uterine bleeding, such as menorrhagia or postmenopausal bleeding. This study focuses on the therapeutic aspect of outpatient hysteroscopy, such as myomectomy, polypectomy, intrauterine adhesiolysis and removal of lost intrauterine devices, etc. Apart from the conventional polyp scissors and biopsy forceps, there are also emerging hysterscopic tissue removal systems, such as Truclear®, that can decrease the operation time and increase success of outpatient hysteroscopic operations.

On such occasions, the outpatient hysteroscopic operation needs to be re-arranged in an inpatient setting in the operation theatre under regional or general anesthesia. Therefore, improvement in pain management can reduce participants' health care experience, participants' anaesthetic and procedural risks, decrease healthcare costs, and reduce inconvenience to participants.

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

详细描述

Outpatient hysteroscopy can serve as a diagnostic procedure to evaluate for abnormal uterine bleeding, such as menorrhagia or postmenopausal bleeding. This study focuses on the therapeutic aspect of outpatient hysteroscopy, such as myomectomy, polypectomy, intrauterine adhesiolysis and removal of lost intrauterine devices, etc. Apart from the conventional polyp scissors and biopsy forceps, there are also emerging hysterscopic tissue removal systems, such as Truclear®, that can decrease the operation time and increase success of outpatient hysteroscopic operations. However, there are still chances of failure; and 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 operations such as hysteroscopic polypectomy. Some factors further enhance the degree of pain experienced, such as nulliparity, post-menopausal status6, cervical stenosis and high anxiety level.

On such occasions, the outpatient hysteroscopic operation needs to be re-arranged in an inpatient setting in the operation theatre under regional or general anesthesia. Therefore, improvement in pain management can reduce participants' health care experience, participants' anaesthetic and procedural risks, decrease healthcare costs, and reduce inconvenience to participants.

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. However, the evidence has been conflicting so far. To date, there was only one published randomized controlled trial regarding the effectiveness of virtual reality in pain management. The study was conducted overseas and limited by small sample size.

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

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 80 Years(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: 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: 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

Wong Tsz Yan, Yanny

Principal Investigator

Chinese University of Hong Kong

研究点 (1)

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