Nitrous Oxide During Office Hysteroscopy for Reducing Pain and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Comparison of Pain During Office Hysteroscopy Between Inhaled Nitrous Oxide (Treatment Group) and Ambient Air (Placebo Group)
研究概览
简要总结
The goal of this clinical trial is to assess the use of inhaled nitrous oxide during office hysteroscopy.
The main questions it aims to answer are:
- Does it reduce pain during the procedure?
- Does it increase the success rate?
- Does it improve patient satisfaction?
- Does it reduce anxiety?
- Which populations benefit more (e.g., parity, menopausal status, number of previous surgeries, type and duration of procedure, and type of device)?
Participants will be asked about their pain levels during the procedure, as well as their anxiety levels. All responses will be recorded.
Written informed consent will be obtained prior to initiation.
详细描述
Office hysteroscopy offers a convenient alternative to operating room-based procedures, yet many patients experience pain and anxiety significant enough to interfere with procedural completion. Nitrous oxide is a fast-acting inhaled agent with both analgesic and anxiolytic properties, widely used in outpatient settings across various medical specialties.
This study will investigate the role of nitrous oxide in improving patient tolerability and comfort during office hysteroscopy. Participants will undergo a standardized procedural protocol with either nitrous oxide or ambient air administered via a demand-valve mask system. Comprehensive data on patient responses during the procedure will be collected and analyzed.
The study will also examine variability in patient responses across different subgroups and procedural types. All procedures will adhere to ethical standards, and patient confidentiality will be maintained throughout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged ≥18 years Scheduled to undergo operative office hysteroscopy for clinical indications
排除标准
- •Any contraindications to N₂O, including:
- •Pneumothorax Significant chronic obstructive pulmonary disease (COPD) Upper airway obstruction Bowel obstruction Middle ear pathology (e.g., recent ear surgery or active ear infection) Severe recent intraocular gas injection Severe vitamin B12 deficiency Known hypersensitivity to N₂O
- •Women who will decline randomization or unable to provide informed consent.
研究组 & 干预措施
treatment- inhaled nitrous oxide
Participants in the Nitrous Oxide group will inhale a fixed 50:50 mixture of nitrous oxide (N₂O) and oxygen (O₂), starting one minute prior to the procedure and continuing throughout its duration.
The gas is administered via a self-administered demand-valve face mask connected to the Blendox system (Ambulanc®, Italy).
干预措施: Inhalation of Nitrous Oxide (N₂O) during Office Operative Hysteroscopy (Procedure)
Inhaled ambient air control group
Participants in the control group will inhale ambient air starting one minute prior to the procedure and will continue inhalation throughout its duration.
The ambient air is administered via a self-administered demand-valve face mask connected to the Blendox system (Ambulanc®, Italy).
干预措施: inhalation of ambient air during office hysteroscopy (Procedure)
结局指标
主要结局
Comparison of Pain During Office Hysteroscopy Between Inhaled Nitrous Oxide (Treatment Group) and Ambient Air (Placebo Group)
时间窗: Periprocedural (start to end of the hysteroscopy procedure)
The difference in pain between the two groups will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 represents the worst imaginable pain. Pain scores will be collected at three time points throughout the procedure : uterine entry, during the procedure, and immediately after its completion.
次要结局
- Incidence of side effects related to inhaled substance(Periprocedural (start to end of the hysteroscopy procedure))
- Procedure completion(Periprocedural)
- Patient satisfaction with the procedure(Immediately post-procedure)
研究者
Dr. Tamar Zur
P.I Dr Tamar Tzur. Senior gynecologist at Maaynei Hayesha
Maaynei Hayesha Medical Center