NCT04436354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
Last Updated

September 24, 2021

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 11, 2020

Last Update Submit

September 19, 2021

Conditions

Uterine Diseases

Keywords

vaginoscopic office hysteroscopylithotomy positiontrendelenburg lithotomy positionvisual pain scoreprocedural timeLikert scale

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • attitudinal Likert type survey

    12 months

Study Arms (2)

vaginoscopic office hysteroscopy in the trendelenburg position

EXPERIMENTAL
Procedure: vaginoscopic office hysteroscopy

vaginoscopic office hysteroscopy in lithotomy position

EXPERIMENTAL
Procedure: vaginoscopic office hysteroscopy

Interventions

vaginoscopic office hysteroscopyPROCEDURE

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

Also known as: positions
vaginoscopic office hysteroscopy in lithotomy positionvaginoscopic office hysteroscopy in the trendelenburg position

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • uterine disorders
  • abnormal uterine bleeding
  • infertility

You may not qualify if:

  • pregnancy
  • cervical disorders
  • pelvic infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital

Istanbul, 34255, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Uterine Diseases

Interventions

Patient Positioning

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 18, 2020

Study Start

November 1, 2018

Primary Completion

January 1, 2019

Study Completion

April 16, 2019

Last Updated

September 24, 2021

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

Locations

TU(1)