跳至主要内容
临床试验/NCT05438238
NCT05438238招募中不适用

Clinical Efficacy of Virtual Reality for Acute Pain and Anxiety Management During Egg Retrieval for in Vitro Fertility Treatment

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Difference in visual analog scale score for Pain

研究概览

简要总结

This study is a comparison between the current standard practice of performing a transvaginal oocyte retrieval (TVOR) with paracervical block (PCB) and a relatively recently developed technology of virtual reality that is added to the above mentioned standard practice of TVOR + PCB. The aim of the study is to find out whether this newer technology has an advantage for the patient, in terms of anxiety and pain reduction or satisfaction.

详细描述

People who wish to become pregnant sometimes have to resort to in vitro fertilisation (IVF) treatment. IVF treatment consists of the injection of hormones on one hand, and the creation and transfer of embryos on the other, with a view to pregnancy. The first part, the hormonal ovarian stimulation, leads to an egg retrieval through the maturation trigger 36h before. On the one hand, people may be very anxious about the unknown procedure, as they do not know what to expect. Due to the fertility problems and fertility treatments with its disappointments, there is also a psychological burden to be taken into consideration. On the other hand, people may experience this procedure as painful, although this varies greatly. Scientific studies show that 90% of women are comfortable during transvaginal oocyte retrieval under local anaesthetic and do not want additional painkillers.

Virtual reality has emerged in recent years as an alternative non-pharmacological treatment that has proven to be effective in treating burns, postpartum episiotomy suturing or in paediatric care.

The aim of this study is to investigate the alternative treatment (Virtual Reality glasses) for its effectiveness in treating anxiety and pain while undergoing transvaginal oocyte retrieval. The Virtual reality headmounted glasses by Oncomfort, CE certified,is a set of headphones with a smartphone screen that offers image and sound as a treatment, during the transvaginal oocyte retrieval, i.e. about 20-30 minutes.

Questionnaires will be filled out by the patients and the physician to evaluate expectations, fear and pain.

Prior to the TVOR, the patient will fill out the pre-operative questionnaire, which will interview their baseline fear, anxiety and expectations. Each patient is instructed on the use of the standard 100mm linear visual analog scale (VAS) with 0 as no pain and 10.0 as the worst pain imaginable.

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •≥18 and ≤ 40 years of age
  • •undergoing fertility treatments
  • •undergoing egg retrieval as part of in vitro fertilization treatment
  • •only first ≤ 3 IVF cycles.
  • •Bilateral ovarian follicular response (>3 and <30 follicles)

排除标准

  • •Hearing impairments and blindness
  • •Motion sickness
  • •Any known anatomical characteristics that may make performing the office procedure impossible.
  • •Patients undergoing a general anesthesia or conscious sedation
  • •lack of informed consent
  • •Chronic alcohol/drug abusers
  • •Transabdominal approach for retrieval
  • •Patients undergoing oocyte retrieval for fertility preservation before cancer or genotoxic treatment - oncofertility preservation
  • •allergy to medications used

研究组 & 干预措施

investigational group A

Experimental

during TVOR +PCB addition of Oncomfort, commercially available Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform IEC62366-1:2015, EN 62304:2006/Amd1:2015, EN 82304-1:2015, EN 82304-1:2016, ISO 13485:2016, EN ISO 14971:2019, EN 60601-1-2:2015

干预措施: Oncomfort (Device)

reference group

No Intervention

standard of care TVOR + PCB

结局指标

主要结局

Difference in visual analog scale score for Pain

时间窗: 1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR

change in pain experience, assessed using visual analog scale (VAS). VAS is a 100mm linear visual analog scale with 0 as no pain and 10.0 as the worst pain imaginable.

次要结局

  • Difference in visual analog scale score for anxiety(1/ pre-procedure baseline 2/ immediately after the procedure and 3/ 5days after TVOR)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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