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

NCT ID: NCT07325994

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-20
• Study Completion Date: 2026-03-15

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.

Detailed Description

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.

Despite this, many women still report moderate to severe pain, particularly during cervical passage and uterine distension. High pain scores may result in incomplete examinations, decreased patient satisfaction, and increased need for sedation or analgesia. Various pharmacological interventions have been studied, including NSAIDs, local anesthetics, and misoprostol, with inconsistent or limited benefit.

Verbal analgesia, a structured communication strategy involving calm, supportive, and reassuring verbal cues, has been shown to reduce procedural pain in other gynecologic settings such as IUD insertion. However, no randomized trial has specifically evaluated structured verbal analgesia in women with primary infertility undergoing vaginoscopic office hysteroscopy. This trial aims to address this evidence gap by comparing verbal analgesia with standard neutral communication, with both groups receiving baseline NSAID premedication.

Conditions

Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

verbal analgesia

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

standard care

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Aljazeera Hospital

OTHER

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Samy aly ashour

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al Gezeera Hospital

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mahmoud alalfy

Role: CONTACT

mahmoudalalfy@ymail.com

+201002611058

Facility Contacts

mahmoud Alalfy

Role: primary

Other Identifiers

verbal analgesia Hysteroscopy

Identifier Type: -

Identifier Source: org_study_id