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

ConditionHysteroscopy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorCairo University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • verbal analgesia

    Behavioral

    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.

  • standard care

    Behavioral

    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.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: Verbal analgesiaExperimental treatment 1 intervention
Group B: standard careSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

pain during OH

It will be measured by 0-10 numerical rating scale where 0 indicates no pain and 10 worst pain imaginable

Time frame
During the procedure (immediately after insertion of hysteroscope, assessed within 5 minutes

Secondary outcomes

1

Patient satisfaction

Patient satisfaction on a 0-10 NRS (0 = no satisfaction, 10 = maximum satisfaction).

Time frame
At the end of the visit (within 30 minutes of procedure completion)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Aljazeera Hospital

Collaborator