← Back to all trials
Not Yet Recruiting
NCT07773376
Warm Versus Room Temperature Saline as a Uterine Distension Medium for Pain Reduction in Women Undergoing Outpatient Hysteroscopy: Protocol for a Randomized Controlled Trial
Conditions: Pain During Outpatient Hysteroscopy, Pain Reduction in Outpatient Hysteroscopy
Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 60
Sponsor: Reem Mohamed
Location: Ain Shams University Maternity Hospital Cairo
Summary
The goal of this randomized clinical trial is to determine whether using warmed saline at 37°C during outpatient diagnostic hysteroscopy can reduce pain compared with room-temperature saline. The study will include women aged 18 to 70 years who are undergoing outpatient diagnostic hysteroscopy. Participants will be randomly assigned to receive either warmed saline at 37°C or room-temperature saline as the fluid used to expand the uterine cavity during the procedure. Data collected will then be used to compare pain scores between the two groups during hysteroscopy and one hour after the procedure. The study will also assess whether participants require additional pain medication and whether the procedure is stopped because of severe pain. The main hypothesis is that warmed saline at 37°C will result in lower pain scores than room-temperature saline.
Eligibility Criteria
Inclusion Criteria:
* Age 18-70 years.
* Ability to understand and report pain using the Visual Analog Scale.
* Willingness to undergo outpatient hysteroscopy and provide written informed consent.
Exclusion Criteria:
* Congenital genital tract malformations: including these patients could introduce a confounding factor because pain may result from difficult anatomy rather than the temperature of the distension medium.
* Previous hysteroscopic procedures: pain perception may be influenced by prior experience rather than the intervention itself
* Suspected pregnancy: standard gynecologic practice considers pregnancy a contraindication to elective diagnostic hysteroscopy
* Active pelvic infection: instrumentation of an infected genital tract may increase morbidity and facilitate ascending infection. Also, pain scores may reflect infection-related pain rather than procedural pain.
Source: ClinicalTrials.gov (NCT07773376). StuddyBuddy aggregates publicly available trial information.