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Environmental Visual Distraction With Nitrous Oxide During Outpatient Hysteroscopy: A Randomized Pilot Study

RecruitingNAAges 25 Years - 60 YearsFemaleOspedale degli Infermi di Biella
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In plain words

What the trial is, and whether it could suit you

This document describes the protocol of a pilot randomized clinical study evaluating the effect of environmental visual distraction combined with nitrous oxide (N₂O) analgesia on the procedural experience of patients undergoing outpatient operative hysteroscopy at the Hysteroscopy Unit of ASL Biella. Office hysteroscopy is widely used for the diagnosis and treatment of intrauterine conditions such as abnormal uterine bleeding, infertility, and endocavitary pathology. Thanks to technological advances and the miniaturization of instruments, many procedures can now be performed in an outpatient setting without general anesthesia. However, pain perception and procedural anxiety may limit patient tolerance and the completion of the examination. Nitrous oxide is commonly used for analgesia in outpatient hysteroscopy due to its rapid onset, reversibility, and favorable safety profile. It allo

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📋 Eligibility rules (as published)
Inclusion Criteria: * Women aged 25 to 60 years Candidates for outpatient hysteroscopy Clinically eligible for nitrous oxide (N₂O) analgesia according to routine clinical practice Able to understand and sign informed consent Exclusion Criteria: * Contraindications to nitrous oxide (N₂O), including: Known or suspected pneumothorax Severe obstructive pulmonary disease Confusional state or altered consciousness Confirmed or suspected pregnancy Previous major cervical surgery (e.g., conization) Refusal or withdrawal of informed consent
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What it tests

  • Environmental Visual Distraction (Virtual Window)
  • The control group receives nitrous oxide (N₂O) analgesia, which is a drug intervention, even though it is part of routine clinical practice.
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Where

1 site
Alessandro Messina
Biella, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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