Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Vaginoscopic Office Hysteroscopy: A Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Egypt
Al Gezeera Hospital
RECRUITING
Giza
Contact Information
Primary
Mahmoud alalfy
mahmoudalalfy@ymail.com
+201002611058
Time Frame
Start Date: 2025-10-20
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 92
Treatments
Experimental: Verbal 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.
Sham_comparator: standard 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.
Related Therapeutic Areas
Sponsors
Collaborators: Aljazeera Hospital
Leads: Cairo University