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.