Study design and setting
This parallel randomized control trial was carried out on 60 first time pregnant women who referred to two childbirth preparation centers in Zanjan city, Iran in 2018-19.
To examine the effect of spiritual counseling on the quality of life (QoL) of women with the first time pregnancy.
Given the indicator of a similar study, with considering , power of 80%, and attrition rate of 15% (17), the sample size of the present study was calculated 30 first time pregnant women in each group.
Inclusion criteria consisted of living in Zanjan city, gestational age of 20-24 weeks, willingness to participate in the study, lack of any psychiatric disorders or use of psychiatric drugs, obtaining scores ≤10 according to Edinburgh Postnatal Depression Scale (EPDS), scores 18 to 36 based on the Cohen Perceived Stress Scale (PSS), and having a normal pregnancy with a singleton fetus.
Exclusion criteria were the presence of any medical or obstetric complication during the study period, being absent more than two counseling sessions, and no access to telephone follow up.
Pregnant women who met the inclusion criteria and signed the informed consent form were allocated into two intervention and control groups using randomized a block size of four. To ensure the concealment of the sequence of enrolment, an opaque sealed envelope system was used (19). Envelope preparation and random allocation sequencing were performed by a person not involved in the research process. In the present study, participants & researcher were not blinded only outcome assessors were blinded. The research process is showen in fig1.
The counseling sessions were designed in accordance with the study by khoda Karmari et al. (20) and the method suggested by Richard and Bergin's (21).
According to the guidelines of the Iranian Ministry of Health, routine childbirth preparation classes were held from the 20th week of gestation every two weeks until the 32nd week of gestation. The sessions focused on making the mothers familiar with the different stages of pregnancy from fertilization to delivery, personal hygiene, nutrition, mental and physical changes during pregnancy, pregnancy risks, childbirth planning, postpartum health, breastfeeding, and child care. However, no spiritual counseling was provided.
The control group only received routine care. A spiritual counseling were integrated with routine care in the intervention group. Spiritual counseling was held in 8 sessions, as a group counseling (8-10 people) for 4 weeks (2 sessions per week for 45 minutes) at preparation classrooms. The main topic of counseling were reported in table 1.
Each session was started with a focus on breathing exercise or the sacred name like "Allah". Next, the counselor provided a description of the subject of the meeting and encouraged the mothers to express emotions, needs, concerns and thoughts on pregnancy. At the same time, the counselor guided the participants to increase their knowledge to choose the appropriate remedy for emotional reactions during pregnancy and pay attention to spiritual aspects of life. Further advice was given as homework. At the end of each session, explanations and summaries was provided and the women discussed about the topic. The counseling was conducted by a midwife that familiar with counseling approaches under the supervision of a clinical psychologist.
The outcome of this study was prenatal QoL of the first time pregnant women. Data were collected using the SF-36 as a standard questionnaire of QoL, which was completed by the groups before and two months after the intervention.
Data collection instruments
It included personal information of woman's age, education, occupation and spouse’s occupational status.
Health-related quality of life (HRQoL) -SF-36
It is a health-related QoL (HRQoL) questionnaire as a multidimensional measure of health status for self or interviewer administration. It is widely used in clinical research and is a reliable and valid measure of health-related QoL in different populations(22, 23). It measures the perceptions of health-related QoL in 8 domains of Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Role-Emotional, Social Functioning and Mental Health. Responses are scored on a 5-point scale, that are transformed into a score of 0–100 with higher scores indicating better functioning or well-being. Validity and reliability of The Farsi version of the questionnaire have been assessed by Montazeri et al. (23).
The statistical analysis was performed using the SPSS software version 16. Descriptive statistics were employed to describe demographic data. The chi-square test was used to compare the demographic characteristics between the groups. The Kolmogorov-Smirnov test revealed that the scores of the QoL and its components had normal distributions. Therefore, to compare total scores and all areas between and within the groups in pre- and post-intervention, the independent t-test and paired samples t-test were applied, respectively. The risk of having a low QoL was estimated using the linear regression model. The level of significance was p< 0.05.