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

doi:10.21203/rs.3.rs-110055/v1

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

https://doi.org/10.21203/rs.3.rs-110055/v1

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Background: To examine the effect of spiritual counseling on the quality of life (QoL) of women with the first 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 significant difference between the two groups (p>0.05). In Post the intervention, the overall QoL showed a statistically significant difference between the two groups (p<0.05). But the physical functioning, body pain, and social functioning domains were not statistically significant (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: Spiritual counseling had a positive impact on improving of QoL in the first 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.

Trial registration: The study was registered at the Iranian Registry of Clinical Trials under the number IRCT20150731023423N12 , 2018-11-06

Psychology

Sexual & Reproductive Medicine

Quality of life

pregnancy

spirituality

women's health

psychological factor

childbirth

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 first pregnancy
Methodology	Parallel Randomized control trial- Not blinded Intervention: Spiritual counseling was held in 8 sessions+ routine care Control: routine care
Study Duration	Expected recruitment start date=2018-11-11 Expected recruitment end date= 2019-02-22
Study centers	Two childbirth preparation centers in Zanjan city, Iran
Objectives	To examine the effect of spiritual counseling on the quality of life (QoL) of women with the first time pregnancy
Number of Subjects	60 randomized patients in two arms; Treatment and Control
Main Inclusion Criteria	Inclusion Criteria Living in Zanjan city,Gestational age 20-24 weeks, willingness to participate in the study, lack of any psychiatric disorders or use of psychiatric drugs , the Edinburgh Depression Inventory Score ≤10 & the Cohen Perceived Stress 18 to 36 ,having a normal pregnancy with a singleton fetus Exclusion criteria Having any medical or obstetric complication , being absent more than two counseling sessions, no access to telephone
Outcome	Quality of life among pregnant women Measure: Health related Quality of life(SF-36)

Protocol title	The Effectiveness of Spirituality Counseling on Quality of Life in First Time Pregnant Women
protocol identifying number	32031
Name and address of the sponsor/funder.	Dr Alireza Shoghli Address: Azadi Blvd, Zanjan University Of Medical Sciences, Zanjan. Postcode No: 4515613191, Tel: +98 24 3314 8300
Name and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of each.	Maleki Azam, PhD in Maternal & Child Health Address 1: Gavazang Road, Zanjan University Of Medical Sciences, Zanjan, Iran, Tel: +98 24334206519 Address2: Azadi Square ,Jomhori Eslami St , Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran, Phone: 024-33156141 Fax: 024 – 33424770, Postal code: 4515613191, Email: [email protected] & [email protected]. ORCID : https://orcid.org/0000-0001-7888-1985
Name(s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the research	Social Determinants of Health Research Center, Zanjan University of Medical Sciences, Zanjan, Iran. Name of recruitment center: Childbirth Preparing Class at Imam Hussein Hospital & Ayatollah Mousavi Hospital of Zanjan, Iran
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.
Quality assurance	The counseling was conducted by a midwife that familiar with counseling approaches under the supervision of a clinical psychologist. A standard questionnaire was used for data collection.

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) reflects 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 defined 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 (15-18). 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 first pregnancy. Given the importance of spiritual care and the presence of limited studies in this field, this study aimed to determine the effect of spiritual counseling on improving of the QoL of women with the first time pregnancy.

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.

Aims

To examine the effect of spiritual counseling on the quality of life (QoL) of women with the first 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 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.

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 fig1.

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 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

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). 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).

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 significance was p< 0.05.

The Participant flow is showen in fig 1.

There were not statistically significant 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 significant 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 significant 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 significant. While in term of "Physical Functioning, Bodily Pain, and Social Functioning" domains, no statistically significant differences were reported (p>0.05).

Comparing before and after scores of QoL and its domains in the control group showed no statistically significant 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 significant improvements (p<0.05). Only the scores of two domains of "Bodily Pain, Social Functioning "were not statistically significant (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).

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 first time pregnant women. However, our results were consistent with some studies that conducted on multiparous or high-risk pregnancy samples (15-18). 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), Liu et al (2019) suggested that yoga or physical activity could be improved the QoL and well-being of pregnant women(25). O’Connor et al. (2018) also reported similar results (26). Our study results emphasized that the spiritual counseling approach compared to other methods can be equally improved the QoL of pregnant women.

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-efficacy (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 findings. 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.

This revealed that the spiritual counseling had a positive impact on improving the QoL of first 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.

Poor QoL in pregnancy is associated with adverse pregnancy outcomes

The spiritual counselling had a positive impact on improving the QoL of first time pregnant women.

Integration of midwifery led counselling with the spiritual approach for improving childbirth preparation content is necessary.

HQoL = Health-related quality of life

QoL= Quality of life

Edinburgh Postnatal Depression Scale (EPDS)

Perceived Stress Scale (PSS)

Ethical Approval: This article was a part of MSc thesis and approved by the Ethics Committee of the Vice Chancellor for Research of Zanjan University of Medical Sciences, Iran, with the approval number IR.ZUMS.REC.1397.024. 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, confidential, and anonymous, and were apprised of their right to withdraw from the research at any time. The study was registered at the Iranian Registry of Clinical Trials under the number IRCT20150731023423N12 , 2018-11-06

Consent for publication

Not applicable.

Availability of data and materials

The data sets used and analyzed during the current study are available from the corresponding author on reasonable request

Competing interests

No potential conflict of interest relevant to this article was reported

Funding Sources. This article was part of MSc thesis and funded by the Research Deputy of Zanjan University of Medical Sciences, Iran, with the approval number (The code " A-11-344-8").

Acknowledgements

We would like to thank the Zanjan University's vice-chancellor of education and vice-chancellor of research and technology for their financial support to carry out the study (The code " A-11-344-8"). We would like to thank the staffs for their collaboration, and mothers for their participation

Authorship

This study was one part of the MSC thesis of M.K,M. The conception, design of the study, and data collection process were undertaken by M.K,M and A.M was the supervisor who also contributed to the design of the study and reporting of the results. K.A and S.F as the second supervisors contributed to all the stages of the study. Analysis, interpretation, and reporting were supervised by S.F and A.M. All authors contributed to the drafting and revising of the article and are in agreement with final version of the manuscript to be submitted to the journal; they also meet the criteria of authorship. S.F was one of the colleagues, but unfortunately he is not alive.

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Table 1 Details of the intervention

Counselling content

The first session was to meet the participants and researcher, to explain the aim, the rules, and brief full program, providing pre-test.

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

Table 2: The comparison of socio-demographic characteristics of participants between two groups

Variable		Groups				P value
		Intervention		Control Number (percent)
		frequency	Percentage	frequency	Percentage
Woman's Education woman	Guidence High school Diploma Academic	2 1 12 15	6.7 3.3 40 50	2 1 10 17	6.7 3.3 33.3 56.7	0.44
Woman's Employment	Employed Housewife	14 16	46.7 53.3	10 20	33.3 66.7	0.43
Spouses ’ employment	Employed Unemployed	17 13	56.7 43.3	21 9	70 30	0.42
Age (years)	Mean ± standard deviation	25.80±6.37		24.30±6.80		0.38
Gestational age (week)	Mean ± standard deviation	21.80±1.27		21.60±1.40		0..56

Table 3: The comparison of quality of life scores between two groups

Variables		Intervention		Control		P value
Variables		Mean	SD	Mean	SD	P value
Physical functioning	Pre test	26.75	8.43	30.25	5.14	0.05
Physical functioning	Post test	31.08	8.29	27.58	5.62	0.06
P value	Paired t test	0.0001		0.07
Bodily pain	Pre test	32.91	22.62	33.75	16.78	0.87
Bodily pain	Post test	33.75	25.24	38.33	20.74	0.44
P value	Paired t test	0.73		0.34
Physical role functioning	Pre test	6.25	5.91	5.20	5.46	0.48
Physical role functioning	Post test	13.33	7.65	6.25	5.44	0.0001
P value	Paired t test	0.0001		0.16
Emotional role functioning	Pre test	16.66	8.47	16.66	8.47	1
Emotional role functioning	Post test	29.16	9.22	16.94	8.32	0.0001
P value	Paired t test	0.0001		0.91
Social role functioning	Pre test	35.41	12.74	37.08	8.97	0.56
Social role functioning	Post test	38.33	11.80	37.91	8.97	0.87
P value	Paired t test	0.18		0.72
Mental health	Pre test	57.00	7.61	58.50	6.45	0.41
Mental health	Post test	62.33	8.78	57.16	6.78	0.01
P value	Paired t test	0.0001		0.45
Vitality	Pre test	49.79	8.44	49.16	8.64	0.77
Vitality	Post test	63.33	4.85	49.16	8.64	0.0001
P value	Paired t test	0.0001		0.18
General health perceptions	Pre test	35.16	7.59	33.83	5.20	0.43
General health perceptions	Post test	46.66	7.46	32.33	4.09	0.0001
P value	Paired t test	0.0001		0.34
Total Quality of Life Score	Pre test	85.66	5.44	86.86	3.36	0.31
Total Quality of Life Score	Post test	96.46	4.44	85.76	4.04	0.0001
P value	Paired t test	0.0001		0.23

Table 4 The linear regression analysis for estimating the risk of poor Quality of Life scores

Group	B	OR	R	R Square	CI 95%	P value
Intervention	-10.70	-0.78	0.78	0.62	-12.89, -8.50	0.0001
Control	(Ref)

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