Relationship Between Bladder Distention and Hysteroscopy Application
|ClinicalTrials.gov Identifier: NCT01848847|
Recruitment Status : Completed
First Posted : May 8, 2013
Results First Posted : December 16, 2013
Last Update Posted : December 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Menorrhagia||Procedure: Hysteroscopy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||102 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Impact of Bladder Distention on Execution of Diagnostic Hysteroscopy Procedure; a Randomised Controlled Trial.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Experimental: Full Bladder
Hysteroscopy conducted under full bladder.
Experimental: Empty Bladder
Hysteroscopy conducted under empty bladder.
- Ease of Cervical Entry [ Time Frame: 2 months ]Ease of cervical entry which will be assessed by Likert scale.The outcome measures in this study were the ease of cervical entry (judged by the individual surgeons using a 5-point Likert scale: very difficult= 1, difficult= 2, fair = 3, easy= 4, and very easy = 5.
- Pain Scoring(VAS) [ Time Frame: 2 months ]Pain scoring was made by 10 cm visual analog scale. pain score (recorded by the patient on a 10 -point visual analog scale (VAS) which means pain increases with increasing number
- Patient Acceptability and Pain Scoring [ Time Frame: two months ]Patient acceptability and pain scoring will be evaluated by Likert scale and visual analog scale.
- Procedure Duration [ Time Frame: two months ]Procedural time which will be measured in minutes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848847
|Namık Kemal University Faculty of Medicine Department of Obstetric and Gynecology|
|Tekirdag, Turkey, 59100|
|Study Director:||Cem Celik, Assist Prof||Namik Kemal University Faculty of Medicine Department of Obstetrics and Gynecology|