Study design and setting
This is a single-center cross-sectional study through a self-administered questionnaire. The anonymous survey questionnaire was designed with five segments to collect data regarding: (1) demographic and baseline characteristics; (2) the COVID-19 status; (3) household income and debt burden during the COVID-19 pandemic; (4) physical exercise during the COVID-19 pandemic; (5) anxiety status. The questionnaire was developed, reviewed and pretested by professors in Obstetrics (Jie Deng and her colleagues). The present study recruited pregnant women from the Department of Obstetrics and Gynaecology, Xiangyang No.1 People's Hospital, Hubei University of Medicine. The study protocol was approved by the Ethics Committee Board at Xiangyang No.1 People's Hospital (No.2019GCP032).
This research uses an online questionnaire. The questionnaire was written and distributed through the Chinese professional survey website Wenjuanxing (http://www.wjx.com, Changsha Ranxing Information Technology Co., LTD, Changsha, China). The source of the subject is limited to the Xiangyang city and its surrounding suburbs. Xiangyang is northwest to Wuhan, approximately 326 km from Wuhan. Wuhan is the capital of Hubei province and the centre of the COVID-19 epidemic in China. Passengers in Wuhan city can travel to Xiangyang via high-speed trains in less than 2 hours. Therefore, the sampling area was representative with respect to its geographic location. The online questionnaires were distributed from March 2 to 16, 2020, through a widely-used WeChat platform for pregnant mothers to those registered for prenatal care in Xiangyang No.1 People's Hospital. All study participants were asked to fill in this questionnaire once during this study. Only fully completed questionnaires could be submitted online. The dwelling area of the participants were identified by network IP addresses.
It took the respondents 5-10 minutes to complete the questionnaire. At the beginning of the questionnaire, we presented the research background and informed participants that our purpose was to help pregnant women improving the preventive behaviors of self-medication. All participants were also be assured that their participation was voluntary and confidential. An electronic informed consent was obtained from each participant prior to starting the investigation.
Data collection
Data collection and input were automatically conducted through Wenjuanxing on the Internet. The collected data from the questionnaires were reviewed and checked for completeness before data entry. Overall, 1,669 participants completed the questionnaires. Fifty six investigators were excluded on the basis of the following criteria: (1) maternal age <15 or >45 years; (2) non-pregnant or with the answer of "already delivered"; (3) subjects with history of anxiety and mood disorders prior to the COVID-19 outbreak; (4) pregnant women with diabetes, hypertension or other pregnancy complications. To avoid repetition, participants who filled out questionnaires with the same IP address (n=32) were excluded from further analysis. Questionnaires (n=64) answered in <1 minutes or >30 minutes were regarded as invalid. After exclusion, a total of 1,517 participants were ultimately included in the analysis (Fig. 1), yielding an effective response rate of 90.89%.
Measures
The average steps per day were recorded by a mobile phone pedometer and calculated for each participant. Background information including maternal age, ethnicity, education level, occupation, marital status, duration of marriage, historic and present pregnancy information, residential areas, family or social history of the COVID-19 exposure, household income levels, whether had bank loans, and physical exercise during pregnancy was obtained.
The Self-Rating Anxiety Scale (SAS), which was originally developed by Zung in 1971 (24), were administrated to assess the anxiety status in pregnant woman. The SAS consists of 20 self-reporting items that describes subjective feelings and manifestation of anxiety. Responding to each item, each participant should indicate how much each statement applies to her in the recent two weeks. Each question is scored on a scale of 1-4 (1=rarely, 2=occasionally, 3=frequently, 4=always). The scores of 20 items are summed up as the total score. To standardize the total score, the total score was multiplied with 1.25. Anxiety status was obtained by the standard total score. Respondents who score <50 are free from anxiety, while those who score ≥50 are regarded as having anxiety (24). SAS was reported to be broadly used and has demonstrated good validity and reliability among Chinese populations (14, 25).
We considered multiple covariates and potential confounding factors between healthy group (SAS score <50) and anxiety group (SAS score ≥50). The demographic variables were defined as follows: age group (<25 years and ≥25 years), parity (primipara and multipara), education level (postgraduate, college or others), occupation (stable income earners and unstable income earners), and having household bank loans (Yes or No). The government of China adopted different types of quarantine measures and other public health measures aiming to reduce the spread of the COVID-19 in different areas according to the COVID-19 infection conditions, these measures also had a great impact on mental health of pregnant women (12, 14). So the residence areas was categorized into three degrees during the COVID-19 pandemic according to the identified numbers of infected patients (No confirmed cases or no new confirmed cases for 14 consecutive days are low-risk areas. There are new confirmed cases within 14 days, the cumulative number of confirmed cases is not more than 50, or the cumulative number of confirmed cases is more than 50, and there is no clustering epidemic within 14 days, which is a medium risk area. The total number of confirmed cases was more than 50, and cluster epidemic occurred within 14 days, which was a high-risk area)(Fig. 1). The epidemic-related variables were considered to be stratification variables, including household income, daily number of walking steps, exercise time and frequency.
Statistical analysis
In descriptive analysis, the continuous and categorical variables were descriptived as Mean SD or n (%) in both health population and anxiety group. Chi-square test was performed to examine the asociation of characteristics between health population and anxiety group. And t test was for continuous variables. All the statistical analysis was used by the SPSS (version 25.0, IBM, NY, USA). All tests were 2-sided, and P value<0.05 was considered as statistically significant.
Anxiety was regarded as the dependent variable, and multivariable logistical regression model by backward method was used estimate the association between health population and anxiety group through univariate model. Odds ratio (OR) with 95% confidence interval (CI) were reported to determine the strength of association of potential factors with anxiety symptoms.