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

Sponsor
Gaziosmanpasa Research and Education Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04436354
Collaborator
(none)
157
Enrollment
1
Location
2
Arms
5.5
Actual Duration (Months)
28.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: vaginoscopic office hysteroscopy
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
157 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
Actual Study Start Date :
Nov 1, 2018
Actual Primary Completion Date :
Jan 1, 2019
Actual Study Completion Date :
Apr 16, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: vaginoscopic office hysteroscopy in the trendelenburg position

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

    		•
    Experimental: vaginoscopic office hysteroscopy in lithotomy position

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual Analog Score for pain [12 months]

      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

    2. procedural times [12 months]

      minutes

    Secondary Outcome Measures

    1. attitudinal Likert type survey [12 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • uterine disorders

    • abnormal uterine bleeding

    • infertility

    Exclusion Criteria:

    • pregnancy

    • cervical disorders

    • pelvic infections

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital Istanbul Turkey 34255

    Sponsors and Collaborators

    • Gaziosmanpasa Research and Education Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatma ketenci gencer, Principle investigator, Gaziosmanpasa Research and Education Hospital
    ClinicalTrials.gov Identifier:
    NCT04436354
    Other Study ID Numbers:
    • GaziosmanpasaTREHa
    First Posted:
    Jun 18, 2020
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fatma ketenci gencer, Principle investigator, Gaziosmanpasa Research and Education Hospital
    vaginoscopic office hysteroscopy
    lithotomy position
    trendelenburg lithotomy position
    visual pain score
    procedural time
    Likert scale
    Additional relevant MeSH terms:
    Uterine Diseases

    Study Results

    No Results Posted as of Sep 24, 2021