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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04436354
Enrollment
157
Registered
2020-06-18
Start date
2018-11-01
Completion date
2019-04-16
Last updated
2021-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Diseases

Keywords

vaginoscopic office hysteroscopy, lithotomy position, trendelenburg lithotomy position, visual pain score, procedural time, Likert scale

Brief 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.

Detailed 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.

Interventions

PROCEDUREvaginoscopic office hysteroscopy

comparison of procedural time and pain scores of patients in different gynecologycal positions

Sponsors

Gaziosmanpasa Research and Education Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* uterine disorders * abnormal uterine bleeding * infertility

Exclusion criteria

* pregnancy * cervical disorders * pelvic infections

Design outcomes

Primary

MeasureTime frameDescription
procedural times12 monthsminutes
Visual Analog Score for pain12 monthsThe 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

Secondary

MeasureTime frameDescription
attitudinal Likert type survey12 monthswith 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026