The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
Primary Purpose
Uterine Diseases
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
vaginoscopic office hysteroscopy
Sponsored by
About this trial
This is an interventional other trial for Uterine Diseases focused on measuring vaginoscopic office hysteroscopy, lithotomy position, trendelenburg lithotomy position, visual pain score, procedural time, Likert scale
Eligibility Criteria
Inclusion Criteria:
- uterine disorders
- abnormal uterine bleeding
- infertility
Exclusion Criteria:
- pregnancy
- cervical disorders
- pelvic infections
Sites / Locations
- Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
vaginoscopic office hysteroscopy in the trendelenburg position
vaginoscopic office hysteroscopy in lithotomy position
Arm Description
Outcomes
Primary Outcome Measures
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
procedural times
minutes
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04436354
First Posted
June 11, 2020
Last Updated
September 19, 2021
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04436354
Brief Title
The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
Official Title
The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
April 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Diseases
Keywords
vaginoscopic office hysteroscopy, lithotomy position, trendelenburg lithotomy position, visual pain score, procedural time, Likert scale
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vaginoscopic office hysteroscopy in the trendelenburg position
Arm Type
Experimental
Arm Title
vaginoscopic office hysteroscopy in lithotomy position
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
vaginoscopic office hysteroscopy
Other Intervention Name(s)
positions
Intervention Description
comparison of procedural time and pain scores of patients in different gynecologycal positions
Primary Outcome Measure Information:
Title
Visual Analog Score for pain
Description
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
Time Frame
12 months
Title
procedural times
Description
minutes
Time Frame
12 months
Secondary Outcome Measure Information:
Title
attitudinal Likert type survey
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
uterine disorders
abnormal uterine bleeding
infertility
Exclusion Criteria:
pregnancy
cervical disorders
pelvic infections
Facility Information:
Facility Name
Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital
City
Istanbul
ZIP/Postal Code
34255
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
We'll reach out to this number within 24 hrs