RecruitingNot ApplicableNCT07325994

Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Office Hysteroscopy

Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Vaginoscopic Office Hysteroscopy: A Randomized Controlled Trial


Sponsor

Cairo University

Enrollment

92 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • o Women aged 18-40 years.
  • Diagnosis of primary infertility (failure to conceive after ≥12 months of unprotected intercourse).
  • Indication for diagnostic office hysteroscopy.
  • Regular menstrual cycles.

Exclusion Criteria6

  • o Secondary infertility.
  • Known pelvic infection, cervicitis, or vaginitis.
  • Use of analgesics within 8 hours prior to procedure.
  • Cervical stenosis, prior failed hysteroscopy, or known uterine anomaly.
  • Contraindication to NSAIDs
  • Pregnancy or suspected pregnancy.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALverbal analgesia

Providers will deliver a standardized verbal analgesia script in a calm, slow-paced, supportive tone, synchronized to procedural steps: * Scope introduction (introitus → external os): "You may feel light pressure as the camera enters-keep a slow, steady breath; you are doing well." * Cervical passage (internal os): "A brief pinch or cramp may happen now; it will pass quickly-breathe in slowly, and out." * Uterine entry and distension: "A feeling of fullness is expected; stay with your breath-it eases in moments." * Cavity inspection: "You may notice short waves of cramp; they are normal and brief-you're managing this well." * Withdrawal: "We are nearly finished-slow exhale as we come out. That's it, you did great." Providers will undergo training to ensure fidelity. All participants will receive ibuprofen 600 mg orally one hour before hysteroscopy as standard analgesia.

BEHAVIORALstandard care

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.


Locations(1)

Al Gezeera Hospital

Giza, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07325994


Related Trials