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NOT YET RECRUITING
NCT07773376
NA

Warm Versus Room Temperature Saline as a Uterine Distension Medium for Pain Reduction in Women Undergoing Outpatient Hysteroscopy: Protocol for a Randomized Controlled Trial

Sponsor: Reem Mohamed

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-09

Completion Date

2026-12

Last Updated

2026-08-19

Healthy Volunteers

Yes

Interventions

OTHER

Warmed Saline at 37 degrees celsius

Normal saline warmed to 37°C and used as the uterine distension medium during outpatient diagnostic hysteroscopy. The temperature of the saline will be monitored using an infrared thermometer before and during the procedure.

OTHER

Room-Temperature Normal Saline

Normal saline at room temperature used as the uterine distension medium during outpatient diagnostic hysteroscopy.

Locations (1)

Ain Shams University Maternity Hospital

Cairo, Egypt