Al Gezeera Hospital
Giza, Egypt
Location status: Recruiting
Location contact
mahmoud Alalfy
CONTACT
NCT Number: NCT07325994
Office hysteroscopy is a cornerstone in the diagnostic evaluation of infertile women, enabling direct visualization of the uterine cavity for identifying intrauterine pathology. The vaginoscopic ("no-touch") approach, which eliminates the use of a speculum and tenaculum, is increasingly adopted due to improved tolerability, higher success rates, and reduced pain compared to conventional methods.
Interested in participating?
Request Info18 year–40 year
Female
Interventional
Not applicable
Giza, Egypt
Location status: Recruiting
mahmoud Alalfy
CONTACT
Office hysteroscopy is a cornerstone in the diagnostic evaluation of infertile women, enabling direct visualization of the uterine cavity for identifying intrauterine pathology. The vaginoscopic ("no-touch") approach, which eliminates the use of a speculum and tenaculum, is increasingly adopted due to improved tolerability, higher success rates, and reduced pain compared to conventional methods.
Despite this, many women still report moderate to severe pain, particularly during cervical passage and uterine distension. High pain scores may result in incomplete examinations, decreased patient satisfaction, and increased need for sedation or analgesia. Various pharmacological interventions have been studied, including NSAIDs, local anesthetics, and misoprostol, with inconsistent or limited benefit.
Verbal analgesia, a structured communication strategy involving calm, supportive, and reassuring verbal cues, has been shown to reduce procedural pain in other gynecologic settings such as IUD insertion. However, no randomized trial has specifically evaluated structured verbal analgesia in women with primary infertility undergoing vaginoscopic office hysteroscopy. This trial aims to address this evidence gap by comparing verbal analgesia with standard neutral communication, with both groups receiving baseline NSAID premedication.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Providers will deliver a standardized verbal analgesia script in a calm, slow-paced, supportive tone, synchronized to procedural steps:
Providers will use neutral, procedural statements without supportive phrasing, e.g., "Starting the camera now," "Passing the cervix," "Entering the uterus," "Inspecting the cavity," "Withdrawing the camera.". All participants will receive ibuprofen 600 mg orally one hour before hysteroscopy as standard analgesia.
Time frame: During the procedure (immediately after insertion of hysteroscope, assessed within 5 minutes
It will be measured by 0-10 numerical rating scale where 0 indicates no pain and 10 worst pain imaginable
Time frame: At the end of the visit (within 30 minutes of procedure completion)
Patient satisfaction on a 0-10 NRS (0 = no satisfaction, 10 = maximum satisfaction).
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Vaginoscopic Office Hysteroscopy: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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