Type of study
This is a methodological study in terms of nature and descriptive cross-sectional in terms of implementation method.
Population, sample size, and sampling method
The population of the present research includes pregnant women, under the coverage of the routine pregnancy care provided by healthcare centers in Tabriz, Iran, who were pregnant at the time of sampling (October 2017 to March 2018).
Since an exploratory factor analysis was made, sample size was assumed to be 160 with 5-10 women considered for each of the 16 items. Then, final sample size was calculated to be 360, given the sample including 200 pregnant women required for the confirmatory factor analysis (10). The multistage random sampling method was used in the research. After 15 centers were randomly selected from the list of all healthcare centers in Tabriz using the www.random.org website, the files of the pregnant women at the time of sampling were examined, then a number of files were selected from each center (using quota random sampling) regarding to the total number of available files using the mentioned website. After giving detailed explanations about the reasons, purposes and methods of the research, the pregnant women were invited to the medical centers via phone call to participate in the study. If agreed, they would be requested to attend the treatment & health centers according to the specified schedules. In that step, they were given comprehensive information about the methods and benefits of the research and the confidentiality of their information. If they agreed to participate in the study, they were reevaluated in terms of the inclusion criteria. If they were eligible, written informed consent for participation would be obtained from them. The inclusion criteria of the study included: age above 18 years, gestational age above 24 weeks, absence of a chronic disease, absence of high-risk pregnancy (including gestational diabetes or preeclampsia), absence of twin pregnancy, absence of assisted reproductive techniques for pregnancy, and voluntary participation. The exclusion criteria of the study included presence of any intellectual or cognitive problems.
Information collection instruments and methods
All the participants completed three questionnaires including a demographic questionnaire, TPDS-P and DASS-21(used for investigation of the criterion validity of TPDS-P), each one described below:
1) Demographic questionnaire: This contained questions on age, marital status, occupation, level of education, and economic status of the participants.
2) TPDS: The original TPDS is composed of two major subscales and a total of 16 items. The first, negative affect subscale contains 12 items regarding the woman’s fear, anxiety, and concerns about pregnancy and postpartum period, and the second partner involvement subscale, contains 4 items regarding her partner’s support during pregnancy. For each of the items, the participants would select one of four alternatives based on their feelings and perceptions of their pregnancies, depending on the severity of their experiences, leading to scores from 0 to 3 assigned to the answers, ultimately (0 for very often, 1 for fairly often, 2 for now and then, and 3 for rarely or never). In the calculation of the final scores, the scores for items 3, 5, 6, 7, 9, 10, 11, 12, 13, 14, and 16 were considered in reverse. The minimum score is 0, and the maximum is 48. Overall, a higher score indicates greater distress. The maximum score for the negative affect subscale is 36, and that for the partner involvement subscale is 12 (1). The cutoff of a high score on the TPDS and its subscales (= distressed woman), was set at the 90th percentile which resulted in the following cutoff scores: for the overall scale > 17, for its subscale ‘NA’ > 12, and for its subscale ‘PI’ >7 (5).
The authors of the research obtained permission for the translation of the original scale into Persian and its adaptation and application. The process of translation and adaptation has gone through using the forward-backward translation approach: Two bilingual translators, including a psychiatrist and a reproductive healthcare specialist, separately translated the original version of the scale into Persian. The two translated versions were compared for the identification of any disagreements and ambiguities. After the points of disagreement were revealed, and a single version was provided, the agreed-on version was translated into English by two native translators with no involvement in the process of investigation. Finally, a committee composed of the translators, first author, and the corresponding author compared the new English version of the scale to the original one and eliminated meaning related problems.
3) DASS: This is an instrument that provides valid and reliable assessments of three constructs: depression, anxiety, and stress (11). Both the internal consistency and concurrent validity of DASS and DASS-21 are in an acceptable to excellent range. Furthermore, the 21-item version has several advantages over the full 42-item one, and can therefore be preferred (4). The original DASS-21, with a total of 21 items, is composed of three subscales: depression, anxiety, and stress. Each subscale contains 7 items, addressing one's conditions over the previous week. A score from 0 to 3 is assigned to each item (3 for Applied to me very much, 2 for Applied to me to a considerable degree, 1 for Applied to me to some degree, and 0 for did not apply to me at all). The score for each subscale can range from 0 to 21. The higher the score, the more severe the depression, anxiety, and stress (9, 12). Since this is the shortened form of the main 42-item scale, the final score for each subscale needs to be multiplied by 2. Then, the categorization in Table 1 can be referred for specification of the severity of the symptoms and interpretation of the scores.
Table 1. Interpretation of DASS scores with respect to the defined cutoff
Severity
|
Depression
|
Anxiety
|
Stress
|
Normal
|
0-9
|
0-7
|
0-14
|
Mild
|
10-13
|
8-9
|
15-18
|
Moderate
|
14-20
|
10-14
|
19-25
|
Severe
|
21-27
|
15-19
|
26-33
|
Extremely severe
|
28 and above
|
20 and above
|
33 and above
|
This version has been translated into Persian by Asghari et al. in 2008, and has exhibited proper psychometric properties (good to excellent) in the Iranian population (9,11)
Statistical analysis
The factor analysis method with SPSS was used for the investigation of construct validity, and the results of the correlation test between the DASS-21 and TPDS-P were used for investigation of the criterion validity.
For the investigation of reliability, internal consistency of the items was examined. For the measurement of internal consistency, the Cronbach’s alpha coefficient was calculated. For the measurement of stability of the results, the test-retest method was used, and intra class correlation coefficient (ICC) was calculated. For that purpose, the questionnaire was redistributed to 30 of the participants after 15 days, and correlation coefficient was examined through the ICC test using SPSS. Values above 0.7 were considered acceptable (13).
The KMO test was used for the examination of sample size adequacy, and the Bartlett’s test of sphericity was used for the identification of suitability of the data for factor analysis. Factor rotation was carried out through varimax rotation. Minimum factor load was considered to be 0.3. Eigenvalues on the Scree plot were interpreted for the specification of the number of factors. The naming of the items was done by considering the original questionnaire and the justification of the naming.
After the exploratory factor analysis was completed, the fitness of the exploratory model was assessed through confirmatory factor analysis. The fit indices were used for the examination of the model fitness. The intended indices and their acceptable values for confirmation of the model are as follows: Chi-square statistic (Bollen, 1989) p < 0.05 , Root mean square error of approximation (RMSEA) < 0.08 , Comparative fit index (CFI) (Goffin, 1993) > 0.9 , Normal fit index (NFI) (Bentler and Bonett, 1980) > 0.9 , Tucker-Lewis index (TLI or NNFI) (Tucker and Lewis, 1998) > 0.9 , Incremental fit index (IFI) (Bollen, 1989) > 0.9 .
Ethical considerations
Before the research began, official permission was obtained from the author of the original version of TPDS, Victor J. M. Pop. Conducting this study was approved by Tabriz University of Medical Sciences (TUoMS) ethical committee. The ethical code was IR.TBZMED.REC.1396.70. All methods were performed in accordance with the relevant guidelines and regulations at TUoMS. Participation in the study was optional and it was done after obtaining written informed consent. Informed consent was obtained from husbands for illiterate women. It was possible for the participants to leave the study whenever they wanted. Before the study was conducted, the purposes of the research were explained to the participants. The information of the participants and their families were kept confidential.