The effect of spiritual counseling on improving of the quality of life among pregnant women: a randomized control trials

Background: To examine the effect of spiritual counseling on the quality of life (QoL) of women with the rst time pregnancy. Methods: This randomized control trial was carried out on 60 pregnant women who recruited at two childbirth preparation centers of Zanjan (Iran) in 2018. The eligible women were allocated into two intervention and control groups according to the 4-block design. The spiritual counseling was carried out in eight sessions, two times per week at 20 -32 weeks of gestation. The control group only received routine cares. The quality of life were measured before and two months after intervention. Results: Overall in pre intervention phase, the quality of life did not show a statistically signicant difference between the two groups (p>0.05). In Post the intervention, the overall QoL showed a statistically signicant difference between the two groups (p<0.05). But the physical functioning, body pain, and social functioning domains were not statistically signicant (p>0.05). According to the linear regression, the risk of poor quality of life in the intervention group was 0.78 times less than of the control group (p= 0.0001). Conclusion: counseling had a positive impact on improving of QoL in the rst time pregnant women. The integration of spiritual counseling in the childbirth education package could be improved the psychological aspect of quality of life more than the physical aspect of quality of life. It can be considered used by healthcare providers for planning childbirth interventions. questionnaire was used for data collection.


Title
The effect of spiritual counseling on improving of the quality of life among pregnant women: A randomized control trials Background Physical and psychological changes during pregnancy affect the social and physical performance, as well as the quality of life (QoL) of pregnant women. There is a gap in the effectiveness of spiritual-based interventions in the culture and context of Iran on health-related QoL in women with the rst pregnancy

Safety considerations
All participants in the study (intervention and control) received routine care, and the intervention, which was in the form of training and counseling, was integrated with the content of the routine care. It was held only the intervention group. The educational intervention did not have any harm to the participants and it was always possible to cancel the study for all participants.

Introduction
Pregnancy is a physiological phenomenon in the women's life. Physical and psychological changes during pregnancy can affect the social and physical performance, as well as the quality of life (QoL) of pregnant women (1). The quality of life (QoL) re ects the subjective perceptions of the individual's situation in life based on the cultural and value system, given the individual's goals, expectations, standards and attitudes (2). According to the World Health Organization (WHO), health-related QoL refers to the physical, psychological, social, and spiritual dimensions of individuals' well-being (2). Furthermore, QoL of pregnant women could be affected by many factors such as gestational age, the social and economic support, and complications before or during pregnancy (3,4). On the other hand, poor pregnancy QoL is associated with adverse outcomes for example preterm labor pain, and pregnancy related symptoms such as fatigue, low back and pelvic pain (5, 6) Additionally, low QoL in pregnancy contributes to low QoL in the postnatal period (7).
Spirituality and religiosity are known as an important components of health and well-being (8).
Accordingly, the European Commission recommends that spiritual care be provided to nursing and midwifery care, to meet the spiritual, religious and cultural needs of the people(9).
Childbearing is one of the ideal condition for enriching spirituality. Some people believe that the process of pregnancy and childbirth as a time to get closer to God and make life more meaningful (10). Spirituality is de ned as sensitivity or attachment to religious values, or to things of the spirit as opposed to material or worldly interests(11). Spiritual experience is a unique experience and includes understanding the meaning of life, positive life experience, feeling happy and life satisfaction (12).
In Iran, spiritual care has not routinely included in prenatal care program, while in recent years, valuable results from the implementation of interventions based on religion and spirituality in improving anxiety, depression and coping with stress has been reported (13,14). The use of spiritual counseling alone or in combination with cognitive-behavioral therapy can help with improving QoL in women with high risk pregnancy, postpartum depression, and fear of labor pain (15)(16)(17)(18). However, there is a gap in the effectiveness of spiritual-based interventions in the culture and context of Iran on health-related QoL in women with the rst pregnancy. Given the importance of spiritual care and the presence of limited studies in this eld, this study aimed to determine the effect of spiritual counseling on improving of the QoL of women with the rst time pregnancy.

Method Study design and setting
This parallel randomized control trial was carried out on 60 rst time pregnant women who referred to two childbirth preparation centers in Zanjan city, Iran in 2018-19.

Aims
To examine the effect of spiritual counseling on the quality of life (QoL) of women with the rst time pregnancy.

Participant
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 rst 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.

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 (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 g1.

Intervention
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.

Outcomes
The outcome of this study was prenatal QoL of the rst 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
Demographic 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).

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 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 signi cance was p< 0.05.

Results
The Participant ow is showen in g 1.
There were not statistically signi cant differences between the two groups before the intervention in terms of demographic characteristics. So that, the groups were homogeneous. Also, the mean age of the participants showed that there was no signi cant difference between the two groups and they were homogeneous in terms of this variable (p<0.05). (Table 2) The mean score of total QoL and all its domains were greater in the control group compared to intervention group and the differences between the groups were not statistically signi cant therefore the two groups are homogeneous before the study.
The post test showed that the overall score of QoL and the area of "Role-Physical, General Health, Vitality, Role-Emotional, and Mental Health" were greater in the intervention group compared to the control group, and the difference between the two groups were statistically signi cant. While in term of "Physical Functioning, Bodily Pain, and Social Functioning" domains, no statistically signi cant differences were reported (p>0.05).
Comparing before and after scores of QoL and its domains in the control group showed no statistically signi cant differences (p>0.05).
Comparing before and after scores of QoL and the area of "Physical Functioning, Role-Physical, General Health, Vitality, Role-Emotional, and Mental Health" in the intervention group showed statistically signi cant improvements (p<0.05). Only the scores of two domains of "Bodily Pain, Social Functioning "were not statistically signi cant (p>0.05) (Table3).
According to the results of linear regression, the risk of poor QoL in the intervention group was 0.78 times less than that of the control group (p= 0.0001)(table 4).

Discussion
The study results showed that spiritual-based counseling could be improved the overall QoL. However, three domains of QoL (physical function, bodily pain, and social function) showed no improvements. The current study emphasized that the spiritual counseling approach improved the psychological aspects of QoL more than the physical aspects. Limited information is available on the effectiveness of spiritual counseling for improving the QoL of the rst time pregnant women. However, our results were consistent with some studies that conducted on multiparous or high-risk pregnancy samples (15)(16)(17)(18). Our results were also consistent with the studies that used different procedures for intervention, for example, Bashirpour et al (2018) showed that the mindfulness-based approach (24) Various ideas have been reported concerning the biological and psychological effects of spiritual experience on diseases have been emphasized in some studies. It can be claimed that some cognitive patterns, psychological characteristics and behavioral patterns created by spirituality-oriented methods lead to strengthening health and improving the physiological function of the body and consequently increase the psychological resistance of the person in poor physical and social situations. Accordingly, religious and spiritual practices lead to increased tolerance, patience, self-control, satisfaction, emotional control, optimism, self-e cacy (based on trust in God's blessing), altruism, kindness and love (12,27,28).
Religious rituals and spirituality can increase QoL through changing people's attitudes, increasing their sense of responsibility towards themselves and others, promoting the search for meaning in the life, having a greater sense of happiness and self-esteem (29).
The effectiveness of the spiritual approach on improving QoL in the different population (30-32) has been shown that spirituality is a universal element (33). Belief in God creates a change in the perspective toward the life (21). The spiritual aspects of pregnancy and childbearing are often neglected in the literature. Integration of midwifery led counseling with the spiritual approach for improving quality of life of women is necessary.
As a limitation, data collection was performed using a self-report questionnaire. Sampling was conducted on the participants of childbirth preparation classes, which can affect the generalizability of ndings.
Also, the long duration of each session could lead to the exhaustion of mothers. However, the women were allowed to have rest and walk for a few minutes during the sessions. Finally, the short follow-up period should be considered by researchers in future studies. The spouses' of women not included in this study that should be considered in future studies.

Conclusion
This revealed that the spiritual counseling had a positive impact on improving the QoL of rst time pregnant women. The integration of spiritual counseling with the educational content of childbirth preparation can improve the psychological aspect of QoL of pregnant women more than the physical aspect. Therefore, it can be used for planning suitable interventions among pregnant women.

Key Points
Poor QoL in pregnancy is associated with adverse pregnancy outcomes The spiritual counselling had a positive impact on improving the QoL of rst time pregnant women.
Integration of midwifery led counselling with the spiritual approach for improving childbirth preparation content is necessary. . All procedures of the study were in accordance to the protocol of the regional ethical research committee and with the declaration of Helsinki 1964. After informing the study's purposes, written consent were obtained from all women. They were informed that their participation were voluntary, con dential, and anonymous, and were apprised of their right to withdraw from the research at any time. The rst session was to meet the participants and researcher, to explain the aim, the rules, and brief full program, providing pre-test.

List Of Abbreviations
Talking about concept of quality of life, self-concept in pregnancy, and checking misconceptions.
Assessing attitudes and beliefs of the pregnant women on spiritual issues, the role of god and religious in her life.
Listening to positive statements of participants based on reading the holy book, and spiritual issues in overcoming or felling calm in stressful situations.
Listening to the physical and mental problems, worries, fears, ambivalence sense in early pregnancy and her actions in daily life.
Focus on human creation discuss concerning the status of women in the continuity of creation Talking about the spiritual aspects of the pregnancy and childbearing.
Focus on the concept of trust, resort, patience, kindness.
Blessings of God and the role of it in reinterpreting concept of pregnancy and overcoming the worrisome symptoms of pregnancy.
Book therapy / listening to Qur'an voices for 10 min.
Strengthening individuals' inner hope and powers for coping with pregnancy and childbearing.
Encourages to create a daily spiritual space of time or place at home.
Encouraging to express their feeling after/ during creating a daily spiritual space.
Talking about the experience of participating in religious programs or doing spiritual issues.
Discuss to the effect of spiritual's beliefs on eating habits on the fetus, taking care of oneself in pregnancy.
Encouraging to refer to people who create a positive sense or comfortable with them.
Book therapy / listening to Qur'an voices for 10 min.
Listening to The "Nature's Music" the sound of birds, rivers and waterfalls… Illustration and slowly moving tone using meditation relaxation technique along or with listening to relaxing music Discuss the strategy of prayer therapy to reduce the worrisome symptoms of pregnancy related to pregnancy and increase hope Express the pleasure and responsibility of being a mother from the point of view of the Quran" Divine Responsibility Reward" Teaching relaxing muscles with deep breathing for getting rid of the stress. Repeat twice daily for 10 to 15 minutes