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NCT Number: NCT07325994

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

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Al Gezeera Hospital

Giza, Egypt

Location status: Recruiting

Location contact

mahmoud Alalfy

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. pain during OH

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

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

Secondary outcomes

  1. Patient satisfaction

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud alalfy

CONTACT

[email protected]

+201002611058

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Collaborators

  • Aljazeera Hospital

Registry information

Official study title

Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Vaginoscopic Office Hysteroscopy: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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