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| Name | Class |
|---|---|
| Aljazeera Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verbal analgesia | Experimental | Providers will deliver a standardized verbal analgesia script in a calm, slow-paced, supportive tone, synchronized to procedural steps:
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| verbal analgesia | Behavioral | Providers will deliver a standardized verbal analgesia script in a calm, slow-paced, supportive tone, synchronized to procedural steps:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction | Patient satisfaction on a 0-10 NRS (0 = no satisfaction, 10 = maximum satisfaction). | At the end of the visit (within 30 minutes of procedure completion) |
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Inclusion Criteria:
o Women aged 18-40 years.
Exclusion Criteria:
o Secondary infertility.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud alalfy | Contact | +201002611058 | mahmoudalalfy@ymail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al Gezeera Hospital | Recruiting | Giza | Egypt |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
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