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

NCT07773376 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • Pain During Outpatient Hysteroscopy
  • Pain Reduction in Outpatient Hysteroscopy

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.

Sponsors & Collaborators

  • Ain Shams Maternity Hospital

    collaborator OTHER

  • Ain Shams University

    collaborator OTHER

  • Reem Mohamed

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07773376 on ClinicalTrials.gov