An observational study in Vasovagal Syncope (VVS) and Presyncope, sponsored by Tanvir Hospital. Active, not recruiting at 1 site in India. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Tanvir Hospital · Observational
The goal of this pilot cross sectional study is to identify participants at risk of vasovagal reaction/syncope(VVR/VVS) during office hysteroscopy. A predictive red flag classification system is being studied to improve procedural safety during office hysteroscopy. Researchers will perform office hysteroscopy as per the standard protocol by vaginoscopic technique. A nurse positioned at the head side of the participant will record signs and symptoms of VVR/VVS. The participant will be asked of the severity of the pain experienced during office hysteroscopy in relation to their menstrual cycle. The procedure will be discontinued at any point the participant wishes to stop.
Office hysteroscopy is increasingly utilized due to advancements in instrumentation and techniques; however, its adoption in routine gynecologic practice remains limited to 10-12% of cases. This under utilization is largely attributed to the perception of pain and lack of financial incentives. Consequently, fewer than 20% of gynecologists employ office hysteroscopy for the evaluation of intrauterine pathology.
Although generally safe, vasovagal syncope (VVS) is the most concerning complication, with a reported prevalence ranging from 0.21% to 1.85%. Other complications include pain, infection, and bleeding. Surgeons often fail to anticipate vasovagal responses during the procedure. This study aims to develop a red flag classification system based on pain response to enable early recognition and prevention of VVS during office hysteroscopy.
Research design This is a single center, prospective observational pilot study enrolling women undergoing office hysteroscopy over 10 months.
Sample Size Calculation As this is a pilot feasibility study, a formal power calculation for hypothesis testing was not applicable. Sample size was determined using a precision-based approach. Based on a published vasovagal event rate of 6.5 % during office hysteroscopy, we estimated that 100 participants would be required to estimate this proportion with a 95% confidence interval and a margin of error of ±5%, using the Wilson score method. No formal stopping rules or interim analyses were pre-specified, consistent with the pilot and exploratory nature of this study.
Statistical Analysis Descriptive analysis will be conducted for continuous and categorical variables. Chi-square tests will evaluate the association between pain classification and vasovagal events. The STROBE checklist will guide reporting.
88 studies on the registry are indexed under Syncope, Vasovagal; 28 are open to participants now.
This study's planned enrollment of 100 is below the median of 140 across 29 observational studies indexed under Syncope, Vasovagal.
Browse Syncope, Vasovagal studies →This is the only study on the registry with Tanvir Hospital as lead sponsor.
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women undergoing office hysteroscopy in the hospital / outpatient
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In office hysteroscopy will utilize 1.9-2.9 mm hysteroscopes (primarily Bettocchi) by the technique of vaginoscopy, without anesthesia or up to level 3a analgesia, in accordance with International Consensus Statement for Recommended Terminology Describing Hysteroscopic Procedures. The choice of distension medium and hysteroscope is left to the operator's discretion. A nurse positioned at the head of the patient will record signs and symptoms of VVR/VVS.
To evaluate the feasibility of a predictive red flag classification system for identifying patients at risk of vasovagal syncope during office hysteroscopy(OH), with the goal of enhancing procedural safety.
During OH, a nurse positioned at the head of the patient will measure and record the tolerance level of the patient at the completion of the procedure using the Red flag Classification: Level Description Classification 0 Pain ≤ normal menstruation (Well tolerated) Green Flag 1. Pain \> menstruation, no signs of distress (Tolerated) Green Flag 2. Level 1 + objective signs (sweating, pallor, malaise) (Tolerated)Red Flag 3. Level 2 + facial pallor ± loss of consciousness (Not tolerated) Red Flag Normal menstruation is when the pain during periods does not interfere with daily activities. The level of pain tolerated by the women in relation to the menstruation. The feasibility will be assessed by 1) the checking the nurses records which capture the pain scores for any delays or missing data, 2 ) the number of post- procedural pain and tolerance score recorded by the nurse, 3) time taken to complete data 4)Completeness of the data. This information will be used to refine the protocol.
Time frame: The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure.
To assess the potential barriers in implementing the red flag classification system, as preparation for a future large-scale validation study
The potential barriers are assessed by 1) reviewing the recruitment rate versus the target sample size, 2 ) drop out rate, 3 ) nurses feedback on the ease of recording the tolerance classification, 4) Patient's understanding of the classification and their acceptability to report pain.
Time frame: The tolerance level will be assessed perioperative/periprocedural, i.e from the initiation of OH procedure until the completion of the OH procedure.
To measure visual analogue score for pain post procedure separately from the tolerance score.
The visual analogue score for pain is described as - zero which is equivalent to no pain and 10 is the worst possible pain
Time frame: The visual analogue score of pain will be assessed postoperative/postprocedural, i.e immediately after the completion of the OH procedure.
To measure the body mass index of participant undergoing office hysteroscopy
To measure the weight in kilograms, height in meters, which will be combined to report body mass index (BMI) in kg/m\^2)
Time frame: BMI is calculated when the participant is enrolled in the study to perform office hysteroscopy.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — all individual participant data (IPD) that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: June 2025 - July 2026
Access criteria: The individual participant data ( IPD ) will be accessible to qualified researchers doing independent scientific research after reviewing the research protocol and statistical analysis plan and execution of data sharing agreement
This study is active, not recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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