Relationship Between Bladder Distention and Hysteroscopy Application
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|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
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): 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|