Study Tool
The study was conducted using a printed data collection sheet for female patients reporting to the outpatient departments of various specialties for different complaints and a similar online-based questionnaire created through Google FormsĀ online survey development software was used for the hospital staff, students, and faculty members at each institute. The questionnaire was first developed in English and then translated into Hindi, Telugu, Marathi, and Bengali by a translating expert. The questionnaire was then validated by faculties from different departments for its language, content, and completeness.
The questionnaire consisted of detailed questions covering seven important domains (Supplementary file). The first was related to demographics, including age, marital status, religion, residential address, education, occupation, socio-economic status, age at menarche, and the number of children (9 questions). The second section had questions related to contraception and its details (3 questions), and the third section was on pre-vaccination menstrual cycle details (5 questions). The fourth section had details of COVID-19 vaccination including the type of vaccine, number of doses and their dates, and the booster dose (4 questions). The fifth section dealt with post-vaccination menstruation details (7 questions), and the sixth category was on the history of COVID-19 infection and its details including time of infection (before, during, or after completion of COVID-19 vaccination schedule), severity, need for hospitalization and its impact on menstrual cycle (5 questions). The seventh category consisted of open and close-ended questions related to physical examination (height and weight), medical and surgical history, history of stress, excessive weight gain or loss, and vigorous exercise in the past 6 months (6 questions).
A pilot study was conducted to check for the validity and reliability of the questionnaire on 20 participants to find any flaws or missing questions. Accordingly, the questionnaire was reviewed again by a group of faculties from the Department of Obstetrics and Gynecology at the coordinating center to further ensure the validity of the questionnaire prior to the initiation of the survey. These 20 participants were excluded from the main study and subsequent analyses.