Study design and setting
This parallel randomized controlled trial was carried out on 60 first time pregnant women who were referred to two childbirth preparation centers in Zanjan a city in the northwest of Iran, 2019. There are three childbirth preparation centers in Zanajn. One of the childbirth preparations centers is located in a hospital and covers most high-risk pregnancies, so sampling was done from only two centers that provide services in the urban health community center.
Aims
To examine the effect of integrating midwifery counselling with spiritual content on improving the antenatal quality of life among first-time pregnant women.
Participant
With considering the 95% confidence level (Z1-α = 1.96), the test power of 80% (Z1-β = 0.85) and based on QOL variable in Zamani's study with the mean and standard deviation in the intervention group (M1=32,10 and S1=2.63), control group (M2=25/90 and S2=2/33), an attrition rate of 15% the sample size of was calculated for 30 pregnant women in each group. (Zamani et al., 2019).
Inclusion criteria consisted of living in Zanjan city, gestational age of 20-24 weeks, willingness to participate in the study, 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 before randomization were the presence of medical or obstetric complications, psychiatric disorders or use of psychiatric drugs, and no access to telephone for follow up. There was no attrition in the study and after the interventions.
Procedure& randomization
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 (Doig & Simpson, 2005). 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 shown in fig1.
Intervention
The counselling sessions were held in an interaction between the counselor and the women by the first author and content of sessions developed under the supervision of a spiritual advisor by following the study of khodaKarmari et al.(Khodakarami et al., 2016) and the method suggested by Richard and Bergin's (Richards & Bergin, 1997). The counselling was held in 8 sessions, as a group counselling (8-10 people) for 4 weeks (2 times per week for 45 minutes) at preparation classrooms. The counselling was conducted by a midwife (the first author) who that familiar with counselling approaches under the supervision of a clinical psychologist. Educational content was prepared using the Holy Quran and religious books (Hadis) and integrated with routine midwifery counselling. The main topic of counselling was reported in table 1.
Each session was started with a focus on breathing exercises or the sacred name like "Allah". Next, the counsellor described the subject of the meeting and encouraged the mothers to express emotions, needs, concerns and thoughts on pregnancy. At the same time, the counsellor 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 were provided and the women discussed the topic.
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 content was included. The control group only received routine care.
Outcomes
The main outcome of this study was to determine prenatal QoL of first-time pregnant women which were collected using the SF-36 as a standard questionnaire of QoL, which was completed by the participants before and two months after the last session.
Data collection instruments
Demographic
It included personal information of a 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 (Lins & Carvalho, 2016; Montazeri et al., 2005). 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 is transformed into a score of 0–100 with higher scores indicating better functioning or well-being. The validity and reliability of The Farsi version of the questionnaire have been assessed by Montazeri et al. (Montazeri et al., 2005).
Data analysis
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 domains between and within the groups in pre-and post-intervention, the independent t-test and paired samples t-test were applied, respectively. The level of significance was p< 0.05.