Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pain in Diagnostic Hysteroscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01873391
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Sandro Gerli, Azienda Ospedaliera S. Maria della Misericordia

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

Condition or disease Intervention/treatment Phase
Pain in Diagnostic Hysteroscopy Procedure: Diagnostic hysteroscopy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 603 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Pain in Diagnostic Hysteroscopy: a Multivariate Analysis.
Study Start Date : May 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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



Primary Outcome Measures :
  1. Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale. [ Time Frame: 5 minutes after the procedure. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873391


Locations
Layout table for location information
Italy
Arbor Vitae Endoscopic Centre
Rome, Italy, 00191
Sponsors and Collaborators
Sandro Gerli
Investigators
Layout table for investigator information
Study Director: Sandro Gerli, MD University Of Perugia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sandro Gerli, Assistant Professor, Azienda Ospedaliera S. Maria della Misericordia
ClinicalTrials.gov Identifier: NCT01873391     History of Changes
Other Study ID Numbers: co2 vs h2o
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014

Keywords provided by Sandro Gerli, Azienda Ospedaliera S. Maria della Misericordia:
Diagnostic hysteroscopy
Pain
VAS
Multivariate analysis
Normal saline
Carbon dioxide