This double-blind randomized controlled trial (Registration ID in IRCT: IRCT2017031720778N18) was conducted in Urmia, in North West of Iran. Women with following criteria were recruited in this study: primiparous women in postpartum period, aged 20 to 35, and understanding the Persian language. Women with following criteria were excluded from the study; having systemic diseases such as diabetes, hypertension, cardiac diseases, stressors events in the past 6 months, using psychotropic drugs and alcohol, women with general health disorders (screened by General Health Questionnaire). Women who consented to participate were randomly assigned to the intervention and control groups, based on the cards A (control group) and B (intervention group).
Sample size was calculated based on the results of a study conducted by Osman et al. with a confidence level of 95% and a power of 80%, 132 women with adding 20% as attrition in sample, 165 were identified in each group.
Sampling and research procedure
A multistage cluster sampling applied. First, Urmia (located in North West of Iran), divided into five areas: center, north, south, west, and east. In each of these areas, all public health centers were known. Four public health centers in each area were randomly chosen. From the determined centers, the number of samples (165) were selected in the form of relative proportions. Women were invited to participate the study by midwife in the health centers and provided an informed consent and randomly assigned into two groups. Then they asked to complete the general health questionnaire, and the Multidimensional Scale of Perceived Social Support (MSPSS).
Measures
Demographic characteristic
A questionnaire was used to obtain information such as age, type of delivery, education level, economic status and family members.
General Health Questionnaire (GHQ 28)
General Health Questionnaire (GHQ 28) was used to screen the subjects’ mental health. The GHQ28 consists of four subscales including somatic symptoms (items 1-7), anxiety/insomnia (items 8-14), social dysfunction (items 15-21) and severe depression (items 22-28). All items are responded on a 4-point Likert scale of none, mild, moderate, and severe which were scored from zero to three. The score 23 or above was the cut-off point for probability of having a mental disorder[25]. Accordingly, women who obtained scores >23 were excluded from the study. The Persian version of GHQ 28 questionnaire was validated by Yaghoubi, et al [26].
Multidimensional scale of perceived social support (MSPSS)
The MSPSS is a tool to measure the perceived social support (emotional, instrumental, informational, and appraisal) from three sources of individuals’ social lives: family, friends, and significant others. This scale developed by Zimet et al. in 1988, contains 12 items[27]. The 7-point Likert-type scale was used for measurements, with ratings from “1 = strongly disagree” to “7 = strongly agree.” The range of possible scores is 12–84, with higher scores representing higher levels of perceived social support. The validity and reliability of MSPSS was approved by Zimet et al[27, 28]. The Persian version of MSPSS was validated in Iran by Salimi et al [29].
The Postnatal Perceived Stress Inventory
The Postnatal Perceived Stress Inventory developed by Razurel et al. [30] was used to measure postnatal perceived stress. It is an instrument with a 27-item rated on a four-point response format with 1 = not at all; 2 = a little; 3 = moderately; 4 = very; and 5 = extremely. It consists of domains of fatigue and organization at home (5 items); relationship with baby (6 items); relationship with body (5 items); feeding the baby (4 items); future plans (3 items); and relationship with partner (4 items). The total scores of the scale ranges from 27 to 135 with a higher score indicating a more perceived stress. For this study, the Postnatal Perceived Stress Inventory was translated into Persian using the following steps: (i) the original English instrument was translated into Persian by one of the researcher
s, (ii) the Iranian version was translated back into English by a bilingual professional person who has not seen the original English version and (iii) the three versions were then compared. Unclear or incorrect translations were discussed between the researcher and the professional translator until agreement was obtained. Thus, the translation process followed the recommendations provided by the California Academic Press [31]. For present study the Cronbach's alpha for the total scale was measured to be 0.89. The alpha coefficients for the subscales ranged from 0.699 to 0.898. The content validity ratio (CVR) was 76.77% and content validity index (CVI) was 82.33% which are acceptable.
Ethical Considerations
The research protocol was approved by the institutional review board and the Ethics Committee of the Urmia University of Medical Sciences (Ref No: Ir.umsu.rec.1395.109). Participants were provided with detailed information about the study and were assured that confidentiality would be maintained at all times. Written consent was obtained prior to data collection.
Intervention
The intervention included individual and group consultation for family, in six sessions with 5-6 participants and one active family member. Every session lasted 1.5-2 hours in each week. Through the sessions, the researcher discussed every simple item in postpartum challenges which may produce stress. Women received a notebook to record their thoughts, feelings and all experiences toward the issues that make them feel stress, anxiety and worries. During the sessions, researcher as a facilitator encouraged them to discuss about their negative and positive experiences. For homework, participants monitored and recorded their fatigue, sleep, rest, activity, breast feeding patterns, relationships and other items. Women in the control group did not receive any intervention and they participated in the program after the completion of intervention. The sessions' content are shown in table 1.
Statistical analysis
Data were analyzed using SPSS software (version 20). Non-parametric Mann-Whitney U test, Wilcoxon test and independent t-test were used for statistical analyses. The normal distribution of data was assessed using the Shapiro-Wilk test. The significance level was set <0.05.