Pain in Diagnostic Hysteroscopy

February 5, 2014 updated by: Sandro Gerli

Pain in Diagnostic Hysteroscopy: a Multivariate Analysis.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

603

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00191
        • Arbor Vitae Endoscopic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal saline
Normal saline is a distension media of uterine cavity in diagnostic hysteroscopy.
Procedure: Diagnostic hysteroscopy
Active Comparator: Carbon dioxide
Carbon dioxide is a distension media of uterine cavity in diagnostic hysteroscopy.
Procedure: Diagnostic hysteroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale.
Time Frame: 5 minutes after the procedure.
5 minutes after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sandro Gerli

Investigators

  • Study Director: Sandro Gerli, MD, University Of Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 1, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

February 6, 2014

Last Update Submitted That Met QC Criteria

February 5, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • co2 vs h2o

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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