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

Uterine Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436354
• Other study ID #: GaziosmanpasaTREHa
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 16, 2019

Study information

• Verified date: June 2020
• Source: Gaziosmanpasa Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: April 16, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• uterine disorders
• abnormal uterine bleeding
• infertility

Exclusion Criteria:

• pregnancy
• cervical disorders
• pelvic infections

Related Conditions & MeSH terms

• Uterine Diseases

Intervention

Procedure:
• vaginoscopic office hysteroscopy
comparison of procedural time and pain scores of patients in different gynecologycal positions

Locations

Country	Name	City	State
Turkey	Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gaziosmanpasa Research and Education Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	procedural times	minutes	12 months
Secondary	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