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

NCT07325994 | Recruiting

• 1 other identifier: verbal analgesia Hysteroscopy
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hysteroscopy

Outcome Measures

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

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

Secondary Outcomes (1)

• Patient satisfaction

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

Study Arms (2)

Verbal analgesia

EXPERIMENTAL

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.

Behavioral: verbal analgesia

standard care

SHAM COMPARATOR

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.

Behavioral: standard care

Interventions

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.

Verbal 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.

standard care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead
• Aljazeera Hospital: collaborator

Study Sites (1)

Al Gezeera Hospital

Giza, Egypt

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Mahmoud alalfy

CONTACT

+201002611058; mahmoudalalfy@ymail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: January 8, 2026
• Study Start: October 20, 2025
• Primary Completion: March 10, 2026
• Study Completion: March 15, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

EG (1)