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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
400
Inhaled nitrous oxide
inhalation of ambient air
Mayanei HaYeshua Medical Center
Bnei Brak, Israel
Comparison of Pain During Office Hysteroscopy Between Inhaled Nitrous Oxide (Treatment Group) and Ambient Air (Placebo Group)
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.
Time frame: Periprocedural (start to end of the hysteroscopy procedure)
Incidence of side effects related to inhaled substance
The number and type of side effects reported during the procedure following administration of the inhaled agent (nitrous oxide or ambient air), including nausea, dizziness and presyncope. Adverse events will be recorded and categorized.
Time frame: Periprocedural (start to end of the hysteroscopy procedure)
Procedure completion
Success is defined as the completion of the planned hysteroscopy procedure without the need for an additional intervention - either a repeat hysteroscopy or transfer to the operating room. The outcome will be measured as the percentage of participants for whom the procedure was successfully completed as planned.
Time frame: Periprocedural
Patient satisfaction with the procedure
Assessed after the procedure by a binary question: "Would you be willing to undergo the same procedure again with the same inhaled agent?" (Yes/No)
Time frame: Immediately post-procedure
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