Pain During Outpatient HysteroscopyVISION-HYSTNCT07473206
Environmental Visual Distraction With Nitrous Oxide During Outpatient Hysteroscopy: A Randomized Pilot Study
A study testing Environmental Visual Distraction (Virtual Window) in people with Pain During Outpatient Hysteroscopy, run by Ospedale degli Infermi di Biella at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women only
- Conditions the study is for
- Pain During Outpatient Hysteroscopy
- What is being tested?
- Environmental Visual Distraction (Virtual Window)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 9 Mar 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Alessandro Messina
Biella
Alessandro Messina, MD, 01515157001, alessandro.messina@aslbi.piemonte.it
About this study
Official title: Preliminary Evaluation of Environmental Visual Distraction Associated With Nitrous Oxide on Procedural Experience During Outpatient Hysteroscopy: A Randomized Pilot Clinical Study
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.
Read more
Nitrous oxide is commonly used for analgesia in outpatient hysteroscopy due to its rapid onset, reversibility, and favorable safety profile. It allows effective pain control without deep sedation and enables quick patient recovery after the procedure.
In addition to pharmacological approaches, environmental strategies aimed at reducing anxiety and discomfort are increasingly studied. In this protocol, a virtual environmental window-a wall-mounted screen displaying relaxing videos such as natural landscapes or marine scenes-is used as a visual distraction tool to potentially improve the patient's procedural experience.
The primary objective is to evaluate the effect of the environmental setting on the patient's experience during hysteroscopy, measured using the Visual Analogue Scale (VAS) for pain after the procedure. The secondary outcome is the rate of referral to the operating room following outpatient hysteroscopy. Results will also be stratified by parity and hysteroscopic instrument used.
The study will enroll 50 patients aged 25-60 years who are eligible for outpatient hysteroscopy and nitrous oxide analgesia. Participants will be randomized into two groups using sealed envelopes. The intervention group will receive nitrous oxide combined with visual environmental distraction, while the control group will receive nitrous oxide alone according to routine clinical practice.
After the procedure, patients will complete the VAS pain scale (0-10) to assess the pain experienced during the intervention. Clinical and procedural data will be collected and analyzed using descriptive and exploratory statistical methods. Outcome assessors will be blinded to group allocation.
The study follows international ethical standards, including the Declaration of Helsinki, Good Clinical Practice guidelines, and European data protection regulations (GDPR). Nitrous oxide is part of routine care and is not the experimental component of the study.
Overall, this pilot study aims to explore whether a simple non-pharmacological environmental intervention can reduce perceived pain and improve patient tolerance during outpatient hysteroscopy, providing preliminary data for future larger studies.
- Conditions
- Pain During Outpatient Hysteroscopy
- Being tested
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental Visual Distraction (Virtual Window)Procedure or surgery
A wall-mounted screen displaying relaxing visual content (e.g., natural landscapes, ocean scenes, or aquarium environments) is activated during outpatient hysteroscopy to provide environmental visual distraction. The visual stimulus begins approximately 5 minutes before the procedure and continues throughout the intervention. This non-pharmacological environmental support is used in addition to standard analgesia with nitrous oxide (N₂O) to potentially reduce perceived pain and improve patient comfort during the procedure.
The control group receives nitrous oxide (N₂O) analgesia, which is a drug intervention, even though it is part of routine clinical practice.Drug
Patients receive inhaled nitrous oxide (N₂O) administered through a buccal-nasal mask starting approximately 5 minutes before the outpatient hysteroscopy procedure and continuing throughout the intervention. Nitrous oxide is used as routine analgesia according to standard clinical practice to reduce pain and anxiety during the procedure. No environmental visual distraction or additional experimental intervention is applied in this group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A wall-mounted screen displaying relaxing visual content (e.g., natural landscapes, ocean scenes, or aquarium environments) is activated during outpatient hysteroscopy to provide environmental visual distraction. The visual stimulus begins approximately 5 minutes before the procedure and continues throughout the intervention. This non-pharmacological environmental support is used in addition to standard analgesia with nitrous oxide (N₂O) to potentially reduce perceived pain and improve patient comfort during the procedure. Receives: Procedure: Environmental Visual Distraction (Virtual Window) |
| Control | Placebo comparator | Patients receive nitrous oxide (N₂O) analgesia alone according to routine clinical practice during outpatient hysteroscopy. Receives: Drug: The control group receives nitrous oxide (N₂O) analgesia, which is a drug intervention, even though it is part of routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during outpatient hysteroscopy measured by Visual Analogue Scale (VAS)
Pain perceived during the hysteroscopy procedure measured using the Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain), assessed immediately after the procedure.
Measured: Immediately after completion of the hysteroscopy procedure (within 5 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start9 Mar 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain During Outpatient HysteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale degli Infermi di Biella
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bianca Masturzo, Ospedale degli Infermi di Biella
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07473206
- Sponsor's protocol ID
- CE342/2025
- Acronym
- VISION-HYST
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of Environmental Visual Distraction Associated With Nitrous Oxide on Procedural Experience During Outpatient Hysteroscopy: A Randomized Pilot Clinical Study
- ClinicalTrials.gov ID
- NCT07473206
- Acronym / sponsor ID
- VISION-HYST / CE342/2025
- Conditions
- Pain During Outpatient Hysteroscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ospedale degli Infermi di BiellaUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 allows effective pain control without deep sedation and enables quick patient recovery after the procedure.
In addition to pharmacological approaches, environmental strategies aimed at reducing anxiety and discomfort are increasingly studied. In this protocol, a virtual environmental window-a wall-mounted screen displaying relaxing videos such as natural landscapes or marine scenes-is used as a visual distraction tool to potentially improve the patient's procedural experience.
The primary objective is to evaluate the effect of the environmental setting on the patient's experience during hysteroscopy, measured using the Visual Analogue Scale (VAS) for pain after the procedure. The secondary outcome is the rate of referral to the operating room following outpatient hysteroscopy. Results will also be stratified by parity and hysteroscopic instrument used.
The study will enroll 50 patients aged 25-60 years who are eligible for outpatient hysteroscopy and nitrous oxide analgesia. Participants will be randomized into two groups using sealed envelopes. The intervention group will receive nitrous oxide combined with visual environmental distraction, while the control group will receive nitrous oxide alone according to routine clinical practice.
After the procedure, patients will complete the VAS pain scale (0-10) to assess the pain experienced during the intervention. Clinical and procedural data will be collected and analyzed using descriptive and exploratory statistical methods. Outcome assessors will be blinded to group allocation.
The study follows international ethical standards, including the Declaration of Helsinki, Good Clinical Practice guidelines, and European data protection regulations (GDPR). Nitrous oxide is part of routine care and is not the experimental component of the study.
Overall, this pilot study aims to explore whether a simple non-pharmacological environmental intervention can reduce perceived pain and improve patient tolerance during outpatient hysteroscopy, providing preliminary data for future larger studies.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Environmental Visual Distraction (Virtual Window)A wall-mounted screen displaying relaxing visual content (e.g., natural landscapes, ocean scenes, or aquarium environments) is activated during outpatient hysteroscopy to provide environmental visual distraction. The visual stimulus begins approximately 5 minutes before the procedure and continues throughout the intervention. This non-pharmacological environmental support is used in addition to standard analgesia with nitrous oxide (N₂O) to potentially reduce perceived pain and improve patient comfort during the procedure. |
| Control | Placebo comparator | Drug: The control group receives nitrous oxide (N₂O) analgesia, which is a drug intervention, even though it is part of routine clinical practice.Patients receive nitrous oxide (N₂O) analgesia alone according to routine clinical practice during outpatient hysteroscopy. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Contraindications to nitrous oxide (N₂O), including:
- Known or suspected pneumothorax
- Severe obstructive pulmonary disease
- Confusional state or altered consciousness
- Confirmed or suspected pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Environmental Visual Distraction (Virtual Window)A wall-mounted screen displaying relaxing visual content (e.g., natural landscapes, ocean scenes, or aquarium environments) is activated during outpatient hysteroscopy to provide environmental visual distraction. The visual stimulus begins approximately 5 minutes before the procedure and continues throughout the intervention. This non-pharmacological environmental support is used in addition to standard analgesia with nitrous oxide (N₂O) to potentially reduce perceived pain and improve patient comfort during the procedure. | Procedure or surgery | Intervention |
| The control group receives nitrous oxide (N₂O) analgesia, which is a drug intervention, even though it is part of routine clinical practice.Patients receive inhaled nitrous oxide (N₂O) administered through a buccal-nasal mask starting approximately 5 minutes before the outpatient hysteroscopy procedure and continuing throughout the intervention. Nitrous oxide is used as routine analgesia according to standard clinical practice to reduce pain and anxiety during the procedure. No environmental visual distraction or additional experimental intervention is applied in this group. | Drug | Control |
Primary outcome
Pain intensity during outpatient hysteroscopy measured by Visual Analogue Scale (VAS)
Time frame: Immediately after completion of the hysteroscopy procedure (within 5 minutes).
Pain perceived during the hysteroscopy procedure measured using the Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst imaginable pain), assessed immediately after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental Visual Distraction (Virtual Window) in people with Pain During Outpatient Hysteroscopy, run by Ospedale degli Infermi di Biella at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Messina, MD (01515157001, alessandro.messina@aslbi.piemonte.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during outpatient hysteroscopy measured by Visual Analogue Scale (VAS) (time frame: Immediately after completion of the hysteroscopy procedure (within 5 minutes).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.