The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy

Study Overview
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Brief Summary
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The present study revealed that the TL position is supposed to be more efficient not only for lowering pain score but also reducing the procedural time. Also, performing hysteroscopy in this position may be easier for doctors than in the lithotomy position.

Detailed Description
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VOH is a widely used diagnostic method and seems to be getting more into outpatient clinics. Despite its huge contribution to clinical practice, pain during the procedure is an important limiting factor. We aimed to investigate the effect of the trendelenburg lithotomy position to the pain and procedural time.However, there is a scarcity of research on this subject. Therefore, the rationale of the study was to enlighten the gap in the literature regarding the pain score and procedural time during VOH for diagnostic purposes in TL position. In order to gain scientific evidence, a randomized controlled trial was conducted to compare pain score and duration of procedure between the standard lithotomy position and TL position. Also, the convenience for the physician performing the procedure was assessed. To the best of our knowledge, this is the first study in the literature investigating the effect of the position of the patient during the procedure on both time, pain, and the convenience for the physician simultaneously.

Official Title
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The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy

Conditions
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Uterine Diseases

Intervention / Treatment
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* Procedure: vaginoscopic office hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: uterine disorders abnormal uterine bleeding infertility Exclusion Criteria: pregnancy cervical disorders pelvic infections

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vaginoscopic office hysteroscopy in the trendelenburg position<br> | Procedure: vaginoscopic office hysteroscopy<br>* comparison of procedural time and pain scores of patients in different gynecologycal positions<br>* Other names: positions;|
| Experimental: vaginoscopic office hysteroscopy in lithotomy position<br> | Procedure: vaginoscopic office hysteroscopy<br>* comparison of procedural time and pain scores of patients in different gynecologycal positions<br>* Other names: positions;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Score for pain | The Visual Pain Scale (VPS) was used to evaluate pain levels with 0 represented pain-free, while 10 described the most severe pain (Ekin et al. 2009; Price et al. 1983). Patients were asked to mark the pain expressing point on the VPS immediately after VOH. The severity of pain is determined by the value of the point (cm) marked by the participant | 12 months | 
| procedural times | minutes | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| attitudinal Likert type survey | with a 5-point attitudinal Likert type survey; a psychometric scale commonly used to score responses in a questionnaire. The ease or difficulty of the procedure was categorized as 1-very easy, 2-easy, 3-ineffective, 4-difficult, 5-very difficult, and the physician performing the procedure marked the appropriate section for each VOH procedure in the scale. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginoscopic office hysteroscopy, lithotomy position, trendelenburg lithotomy position, visual pain score, procedural time, Likert scale