Uterine DiseasesNCT04436354
The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
A study testing vaginoscopic office hysteroscopy in people with Uterine Diseases, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Diseases
- What is being tested?
- vaginoscopic office hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2018to 16 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- uterine disorders
- abnormal uterine bleeding
- infertility
Who cannot join
- pregnancy
- cervical disorders
- pelvic infections
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Saglik Bilimleri University Gaziosmanpasa Training and Research Hospital
Istanbul, 34255
About this study
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.
Read the 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.
- Conditions
- Uterine Diseases
- Being tested
- vaginoscopic office hysteroscopy
- Keywords
- vaginoscopic office hysteroscopy, lithotomy position, trendelenburg lithotomy position, visual pain score, procedural time, Likert scale
- Medical subject headings
- Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vaginoscopic office hysteroscopyProcedure or surgery
Also called positions
comparison of procedural time and pain scores of patients in different gynecologycal positions
| Study group | Role | What they receive |
|---|---|---|
| vaginoscopic office hysteroscopy in the trendelenburg position | Experimental | Not described Receives: Procedure: vaginoscopic office hysteroscopy |
| vaginoscopic office hysteroscopy in lithotomy position | Experimental | Not described Receives: Procedure: vaginoscopic office hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
procedural times
minutes
Measured: 12 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Nov 2018
- Primary completion1 Jan 2019
- Study completion16 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma ketenci gencer, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436354
- Sponsor's protocol ID
- GaziosmanpasaTREHa
- Status last verified
- Jun 2020
- First submitted
- 11 Jun 2020
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Trendelenburg Lithotomy Position on Pain and Procedural Time During Vaginoscopic Office Hysteroscopy
- ClinicalTrials.gov ID
- NCT04436354
- Acronym / sponsor ID
- GaziosmanpasaTREHa
- Conditions
- Uterine Diseases
- Keywords
- vaginoscopic office hysteroscopy, lithotomy position, trendelenburg lithotomy position, visual pain score, procedural time, Likert scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 16 Apr 2019 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaginoscopic office hysteroscopy in the trendelenburg position | Experimental | Procedure: vaginoscopic office hysteroscopy |
| vaginoscopic office hysteroscopy in lithotomy position | Experimental | Procedure: vaginoscopic office hysteroscopy |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- uterine disorders
- abnormal uterine bleeding
- infertility
Key exclusion criteria (3 listed)
- pregnancy
- cervical disorders
- pelvic infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vaginoscopic office hysteroscopyAlso: positionscomparison of procedural time and pain scores of patients in different gynecologycal positions | Procedure or surgery | vaginoscopic office hysteroscopy in lithotomy position, vaginoscopic office hysteroscopy in the trendelenburg position |
Primary outcome
Visual Analog Score for pain
Time frame: 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
procedural times
Time frame: 12 months
minutes
1 secondary outcome
attitudinal Likert type survey
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vaginoscopic office hysteroscopy in people with Uterine Diseases, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Score for pain (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.