Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Office Hysteroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: verbal analgesia, standard care.
- Who it may be relevant to
- Registry conditions: Hysteroscopy. Basic parameters: 18 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Verbal Analgesia Versus Standard Care for Pain Control in Women With Primary Infertility Undergoing Vaginoscopic Office Hysteroscopy: A Randomized Controlled Trial
Overview
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.
Interventions
- Behavioral 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 - 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.
Primary outcome measures
- pain during OH [Time frame: During the procedure (immediately after insertion of hysteroscope, assessed within 5 minutes]
Secondary outcome measures (1)
- Patient satisfaction [Time frame: At the end of the visit (within 30 minutes of procedure completion)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Al Gezeera Hospital — Giza
Identifiers
NCT: NCT07325994 · verbal analgesia Hysteroscopy