Pain in Diagnostic Hysteroscopy

Pain in Diagnostic Hysteroscopy Clinical Trial

Official title:

Pain in Diagnostic Hysteroscopy: a Multivariate Analysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873391
• Other study ID #: co2 vs h2o
• Status: Completed
• Phase: N/A
• First received: June 1, 2013
• Last updated: February 5, 2014
• Start date: May 2013
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: Azienda Ospedaliera S. Maria della Misericordia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 603
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Pain in Diagnostic Hysteroscopy

Intervention

Procedure:
• Diagnostic hysteroscopy

Locations

Country	Name	City	State
Italy	Arbor Vitae Endoscopic Centre	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Sandro Gerli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale.		5 minutes after the procedure.	Yes