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New treatment option for Pain During Outpatient Hysteroscopy
Official title Environmental Visual Distraction With Nitrous Oxide During Outpatient Hysteroscopy: A Randomized Pilot Study
ClinicalTrials.gov ID: NCT07473206
What this study is testing
What is The control group receives nitrous oxide (N₂O) analgesia, which is a drug intervention, even though it is part of routine clinical practice.?
The control group receives nitrous oxide (N₂O) analgesia, which is a drug intervention, even though it is part of routine clinical practice. is an investigational medicine, given as an inhaled treatment, being studied as a potential treatment for pain during outpatient hysteroscopy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 60, women only
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Biella, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 25 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Biella, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.