Calm verbal coaching versus usual communication for pain during office hysteroscopy in women with primary infertility
Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Vaginoscopic Office Hysteroscopy: A Randomized Controlled Trial
This compares calm, supportive verbal coaching to usual communication to see if it reduces pain during office hysteroscopy in women with primary infertility.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT07325994 on ClinicalTrials.gov |
What this trial studies
This interventional trial enrolls women aged 18–40 with primary infertility who are scheduled for vaginoscopic (no‑touch) office hysteroscopy. All participants receive baseline NSAID premedication and are then assigned to either a structured verbal analgesia protocol (calm, supportive, reassuring cues during the procedure) or standard neutral communication. The study measures patient‑reported pain scores during key procedure steps, completion rates, and need for additional analgesia or sedation. The aim is to determine whether a simple communication strategy can improve tolerability and reduce procedural pain compared with usual care.
Who should consider this trial
Good fit: Women aged 18–40 with primary infertility, regular cycles, and an indication for diagnostic office hysteroscopy are ideal candidates.
Not a fit: Patients with secondary infertility, cervical stenosis, prior failed hysteroscopy, contraindication to NSAIDs, active pelvic infection, or suspected pregnancy are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could reduce pain and increase the comfort and completion rate of office hysteroscopy without additional drugs or equipment.
How similar studies have performed: Structured verbal analgesia has shown pain reduction in other gynecologic procedures like IUD insertion, but randomized data in vaginoscopic hysteroscopy for primary infertility are lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Giza
- Al Gezeera Hospital — Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Mahmoud alalfy
- Email: mahmoudalalfy@ymail.com
- Phone: +201002611058
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.