Ignite Creation Date:
2025-12-24 @ 1:20 PM
Ignite Modification Date:
2025-12-29 @ 5:08 PM
Study NCT ID:
NCT07074795
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-20
First Post:
2025-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of Nitrous Oxide During Office Hysteroscopy
Sponsor:
Maaynei Hayesha Medical Center
Organization:
Study Overview
Official Title:
Nitrous Oxide During Office Hysteroscopy for Reducing Pain and Anxiety
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: