Visual distraction plus nitrous oxide to reduce pain during outpatient hysteroscopy
Preliminary Evaluation of Environmental Visual Distraction Associated With Nitrous Oxide on Procedural Experience During Outpatient Hysteroscopy: A Randomized Pilot Clinical Study
This will test whether adding a virtual-window visual distraction to nitrous oxide pain relief makes outpatient hysteroscopy more comfortable for women aged 25–60.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 25 Years to 60 Years |
| Sex | Female |
| Sponsor | Ospedale degli Infermi di Biella Academic / other |
| Locations | 1 site (Biella) |
| Trial ID | NCT07473206 on ClinicalTrials.gov |
What this trial studies
This is a randomized pilot comparing environmental visual distraction (a 'virtual window') combined with nitrous oxide (N2O) analgesia versus nitrous oxide alone for women undergoing outpatient operative hysteroscopy at ASL Biella. Participants who are clinically eligible for N2O will be randomized to receive the virtual-window visual distraction during the procedure or standard care with N2O only. The trial focuses on procedural experience measures such as pain perception, anxiety, tolerability, and completion of the examination. The intervention is noninvasive and performed in the outpatient hysteroscopy unit with rapid recovery expected after N2O use.
Who should consider this trial
Good fit: Women aged 25 to 60 who are scheduled for outpatient hysteroscopy, are clinically eligible for nitrous oxide analgesia, and can give informed consent are ideal candidates.
Not a fit: Patients with contraindications to nitrous oxide (for example pneumothorax, severe obstructive pulmonary disease, suspected pregnancy, altered consciousness), prior major cervical surgery, or those who decline participation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the combination could make outpatient hysteroscopy less painful and less anxiety-provoking, improving patient comfort and the likelihood of procedure completion without general anesthesia.
How similar studies have performed: Nitrous oxide is an established outpatient analgesic and distraction techniques have reduced procedural distress in other settings, but combining a virtual-window visual distraction with N2O for hysteroscopy is a novel, pilot approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Biella
- Alessandro Messina — Biella, Italy (Recruiting)
Study contacts
- Study coordinator: Alessandro Messina, MD
- Email: alessandro.messina@aslbi.piemonte.it
- Phone: 01515157001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.