Pain in Diagnostic Hysteroscopy

Not Applicable

Completed

• Conditions: Pain in Diagnostic Hysteroscopy
• Interventions: Procedure: Diagnostic hysteroscopy

• Registration Number: NCT01873391
• Lead Sponsor: Sandro Gerli

Brief Summary

The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-01
• Study First Submitted QC: 2013-06-06
• Study First Posted: 2013-06-10
• Status Verified: 2014-02
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 603

Inclusion Criteria

• female gender
• diagnostic hysteroscopy indication
• italian-speaking patients

Exclusion Criteria

• patients who had previously undergone a diagnostic hysteroscopy
• patients who had been previously undergone to cervical surgery
• ongoing pregnancy
• cervical carcinoma
• pelvic inflammatory disease
• excessive uterine bleeding
• performance of an endometrial biopsy during the procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Diagnostic hysteroscopy	Normal saline is a distension media of uterine cavity in diagnostic hysteroscopy.
Carbon dioxide	Diagnostic hysteroscopy	Carbon dioxide is a distension media of uterine cavity in diagnostic hysteroscopy.

Primary Outcome Measures

Name	Time	Method
Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale.	5 minutes after the procedure.

Trial Locations

Locations (1)

Arbor Vitae Endoscopic Centre; 🇮🇹 Rome, Italy