The Effectiveness of integrating spirituality into prenatal care on Improving Sleep Quality and Insomnia Severity among Pregnant Women: A Randomized Control Trial


 Background

To determine the effectiveness of integrating spirituality into prenatal care on Improving Sleep Quality and Insomnia Severity among Pregnant Women.

Methods

This randomized controlled trial was carried out on 40 pregnant women recruited at five health centers of zanjan, Iran, 2020. The eligible women were allocated into two intervention and control groups according to the randomized design. Group counselling with spiritual content was carried out in eight sessions, two times a week at 16 to 20 weeks of gestation. The control group only received routine care. Data were collected using the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI) questionnaires in three stages, before the intervention, at 28 and 36 weeks of gestation. Statistical analysis was performed using the SPSS 16.0 software (SPSS Inc., Chicago, IL, USA).

Results

The results showed that comparing the mean score of insomnia severity, sleep quality and its components in the pre-intervention phase was not statistically significant between the two groups(p>0.05). Comparison of the insomnia severity, sleep quality, and its components scores decreased statistically in the second and third trimesters compared to the first trimester in the intervention group than the control group(p<0.05). The effect of the intervention (Eta score) was 64%.

Conclusion

The results showed that counselling with spiritual content could effectively ameliorate sleep quality and reduce insomnia severity in pregnant women. It seems that the approach is an acceptable basis to design intervention programs in this field that can be considered by midwives.


Background
One of the most common complaints during pregnancy is to have sleep disorders, such as insomnia, frequently waking up at night, high drowsiness during the day, mood swings, and unusual feelings during sleep (1). In one review, more than 80% of pregnant women had sleep disorders (2). According to the results of other studies, nearly half of pregnant women (45.7%) suffer from poor sleep quality and 50% from insomnia(1, 3) A person's ability to fall asleep and the positive feeling after waking up indicate an ideal sleep quality (4). The quality varies in the different trimesters of pregnancy. So that, the prevalence of sleep disorders can be different from 63% in the rst trimester to 80% in the second trimester (5). Sleep disorders during pregnancy can increase unfortunate consequences, such as preeclampsia, preterm labor, miscarriage, urgent cesarean delivery, gestational diabetes, postpartum depression, high levels of interleukin-6 (6-9).
To date, some studies have been conducted to improve sleep quality in pregnant women using a variety of pharmacological and non-pharmacological methods, each of which had different e cacy (10)(11)(12).
Today, religious beliefs are considered by many researchers as major factors that affect physical and mental health and treat sleep disorders (13)(14)(15)(16).
If spiritual health is at risk, the development of mental disorders, such as loneliness, anxiety, and loss of meaning in life will be likely. However, strengthening the spirituality in patients allows them to adapt effectively to their problems. Therefore, being connected with higher power and support from spiritual or religious sources can improve one's quality of life, control mental health disorders, and create interpersonal support (17). In some studies, the use of spiritual counselling has been emphasized in various aspects of pregnancy and childbirth, such as the stress during pregnancy and childbirth selfe cacy (18,19). Spirituality is a key factor in promoting maternal and fetal health (18)(19)(20); it plays an important role in the acceptance of pregnancy (21). According to studies, spiritual counselling has been effective in improving sleep quality for coronary artery disease patients (13), hemodialysis patients (14), women with breast cancer (15), and the elderly (16). Nevertheless, there is an information gap in the effectiveness of spiritual content counselling in improving sleep quality for women during pregnancy.
Given the importance of culture and religion in many countries and the role of midwives in identifying the attitudes and spiritual beliefs of the individuals, the present study aimed to determine the effectiveness of spiritual content counseling on improving the sleep quality and insomnia severity of pregnant women.

Setting and participants
The present study was a randomized control trial to determine the effectiveness of counselling with spiritual content to improve prenatal sleep quality and to reduce sleep intensity in 2020. The research setting included 5 health centers in Zanjan,Iran, city, and the research community included pregnant women referred to the centers. The sample size was calculated 16 people in each group based on the results of the similar study with considering 95% con dence interval, 80% power, the standard deviation of sleep quality 4.24 and 1.86 in two intervention and control groups respectively (22). Due to the possibility of a 10% attrition in sample size, it increased to 20 in each group. Thus, 40 eligible pregnant women were selected using the convenience sampling method and assigned to the two control and intervention groups via the simple random method. The inclusion criteria were the age group of 18 to 35 years, the gestational age of 20-16 weeks, willingness to participate in the study, scoring more than 5 based on The Pittsburgh Sleep Quality Index (PSQI), and scoring less than 22 based on the General Health Questionnaire (GHQ-28). The exclusion criteria were more than two absences from counselling sessions, consumption of sleeping pills for sleep control, medical and obstetrics complications during the study, withdrawal from the study, and participation in a similar training program (Chart 1 Participant owchart).

Procedure/ Intervention
For the intervention group, spiritual content counselling was conducted based on the protocol of spiritual skills of Boulehri (23) and the study protocol of Asadi Zandi et al. (13). Accordingly, eight groups (groups of 6-8 people) were held for four following weeks. All the counselling sessions were attempted to use the principles and techniques of counselling to communicate effectively. The counselling session was full of respect and intimacy, high self-con dence to provide an incredible opportunity for individuals to participate in group discussions. The content of each counselling session is listed in Table 1. The counselling was conducted by a midwife that familiar with group counselling under the supervision of a clinical psychologist.
Data were completed by participants using the personal information questionnaire, the Pittsburgh quality sleep questionnaire and the insomnia severity index questionnaire in three-stage, before the intervention, 28 and 36 weeks of gestational age.
Individual information questionnaire seventeen are multiple-choice. Scoring multiple-choice questions on a Likert scale ranges from zero to three, with no "zero scores" option, less than once a week "score one", once or twice a week "score two" and three More or less "points" are awarded during the week. Therefore, the total score range of the questionnaire varies from zero to 21. People who score ve or less on the Pittsburgh Quality Sleep Questionnaire are considered to have a good sleep, and those who score more than ve are considered undesirable. The reliability coe cient of the questionnaire in the study of Baysse et al. was 0.85 (24). In the study of Behroozifar et al., the reliability of the Persian version of the questionnaire was reported to be 0.74 (25).

Insomnia Severity Index (ISI)
The insomnia severity Index is a brief self-report tool that assesses the patient's perception of the intensity of insomnia. This index has seven questions that evaluate the inability to start sleeping, inability to continue sleeping in the form of frequent waking up, waking up early, satisfaction with sleep patterns, daily dysfunction, signi cant insomnia problem for others, and anxiety (26). Scoring questions on 5 Likert scales ranges from zero (never) to 4, so the score range is between 0 and 28. The total score of the questionnaire is obtained by adding the score of the items. Higher scores indicate the high intensity of The General Health Questionnaire (GHQ-28) The 28-question form of the General Health Questionnaire (GHQ-28) was developed by Goldberg and Hiller in 1979. The questionnaire measures a person's general health in the last month (29) and includes four areas of physical complaints: anxiety, social maladaptation, and depression. GHQ-28 scoring is based on the patient's response from no way until more than usual, which is graded from zero to 3. If the total score of each eld is more than or equal to 14, it indicates a disorder in that eld, and if the total score of the questionnaire is more than 23, it indicates a disorder in general health. The questionnaire has the desired validity and reliability (30). Cronbach's alpha coe cient of the Persian version of the questionnaire in the study of Taghavi et al. was reported to be 0.90 (31).

Statistical methods
Data were analyzed using SPSS software version 16 and ANCOVA, chi-square test, independent t-tests.

Result
Baseline data The mean age of women in the intervention group was 26.65 years, in the control group was 28.55 years; the mean gestational age was 18.60 in the intervention group and 18.20 in the control group. Comparing the gestational age and age of women between the two groups was not statistically signi cant (p>0.05).
The results of Table 2 show that the comparison of individual pro le variables in the two groups was not statistically signi cant, so the two groups were homogeneous(p>0.05).

Sleep Quality
The results of Table 3 show that comparing the mean score of sleep quality and its components in the pre-intervention phase was not statistically signi cant(p>0.05). Comparison of the overall score of sleep quality and its subjective sleep quality, sleep latency, sleep duration, sleep disturbances, use of sleeping medication, and daytime dysfunction components increased in the second and third trimesters compared to the rst trimester in the control group and decreased in the intervention group. The observed differences between the two groups were statistically signi cant(p<0.05). However, the score of the habitual sleep e ciency component did not change much in either group during the three trimesters and neither participant in the two groups used the drug to control sleep(p>0.05). A comparison of the mean scores between the two groups in three time periods is shown in Figure 2.

Insomnia Severity
The results of Table 4 show that the mean score of insomnia severity in the pre-intervention phase was 7.05 in the control group and 7.05 in the intervention group. Comparing the mean insomnia severity in the pre-intervention phase was not statistically signi cant, so they were homogeneous(p>0.05). In the control group, the comparison of the mean insomnia severity in the second and third trimesters increased compared to before the intervention and decreased in the intervention group. The observed differences between the two groups were statistically signi cant(p<0.05). It was signi cant to compare the mean scores in the three time periods between the two groups(p<0.05) ( gure3). The effect size of intervention ("Eta" score) at the end of the follow-up period was about 0.66, it shows that counselling with a spiritual content was associated with a 66 % reduction in the severity of insomnia.

Discussion
The results of the present study showed that counselling with a spiritual approach was effective in improving the sleep quality in pregnant women. In the intervention group, the mean score of sleep quality decreased in the second and third trimesters compared to the control group. Although no available studies were showing the effect of spiritual content counselling on sleep quality during pregnancy, the positive effects of spiritual counselling on improving sleep quality have been reported in the non-pregnant research community. Taheri et al. (2013) showed that after spiritual care based on the "Ghalb Salim" nursing model, the mean score of sleep quality in patients with coronary artery disease had a statistically signi cant difference in comparison with the control group (13). Soheili et al. (2013) in a similar study found that the score of disabled veterans' sleep quality after spirituality training based on the teachings of Islam was signi cantly reduced (32). In the present study, spiritual content counselling had a signi cant effect on all areas of sleep quality, except for habitual sleep e ciency. However, in the above studies, an improvement was observed in all areas of sleep quality.
Some studies have emphasized various beliefs about the biological and psychological effects of spiritual-oriented counselling (33,34). Spirituality, as a powerful factor, can in uence one's attitude, cognition, and behaviour, and as a mediator can affect one's thinking and evaluation process (35). In the Qur'an, God describes sleep with the word "Noum" and says in the ninth verse of Surah Naba "We have made your sleep a source of peace, the mentally and physically rejuvenation, and to rebuild the worn-out limbs and relieve any fatigue or discomfort". From the content of the tenth verse of Surah Anfal, it is clear that sleep causes the elimination of fear and the feeling of security. This shows that sleep and a sense of security complete each other(36).
The peace of mind caused by religious activities (e.g., listening to religious sounds) has been emphasized to reduce anxiety and pain during pregnancy (37,38). Peace of mind and healthy sleep are essential in exuding positive hormones from the brain, improving protein metabolism, increasing the function of the immune system, and reducing the stress reactions in the body (34). According to our result, another positive effect of spirituality-based counselling is the improvement of sleep quality during pregnancy, from which the providers can bene t in the form of maternity care service packages.
In the present study, we used religious sounds during relaxation and meditation exercises, which had similar effects on the results of mindfulness and relaxation-based interventions (12). Mindfulness strategies play a role in reducing stress and regulating emotional response. For instance, yoga leads to communication with higher and superior powers. The results of the present study show that spiritual counselling as well as the two interventions listed are useful in reducing the cognitive and physical arousal associated with insomnia in pregnancy.
In the present study, part of the intervention focused on sleep health education and identifying sleep stimuli. It seems that increasing spiritual attention, along with health advice and behaviour modi cation, can have a positive effect on sleep quality. The present study was consistent with that of Lee et al. in 2017, and they showed that health behaviour education bases on the BETTER approach can be signi cantly reduced insomnia symptoms compared to the control group among 25 pregnant women who admitted to the hospital (39).
The results of the present study showed that after the intervention, the mean score of the areas of subjective sleep quality, sleep latency, sleep duration, sleep disturbances, use of sleeping medication, and daytime dysfunction in the intervention group decreased signi cantly. In contrast, the score of these areas in the control group had signi cant increase. Comparing the scores of habitual sleep e ciency in the two groups was not statistically signi cant. Also, none of the participants in either group used medication to control sleep disorders. In a clinical trial study, Felder et al. examined the e cacy of digital counselling using the cognitive-behavioural approach in treating the symptoms of insomnia among 208 pregnant women with a mean gestational age of 17 weeks. The intervention group received 6 sessions of online counselling per week in 5 areas (sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene training), and the control group received routine care. The follow-up period was 10 weeks after the end of the intervention. The results showed that the mean score of sleep quality and habitual sleep e ciency in the intervention group was signi cantly lower than the control group, while the mean score of sleep duration did not differ (40). The results of the above study were consistent with the results of the present study in terms of overall sleep quality score, but not in terms of habitual sleep e ciency and sleep duration, which can be due to easy access to an online consultant.
The results of a review of 24 articles show that the mean score of sleep quality during pregnancy was 6.07. About 45.7% of pregnant women experience some degree of diminished sleep quality during pregnancy. However, changes in sleep quality score increase in the third trimester were 1.68 times higher than in the second trimester (2). In the present study, the changes in the overall score of sleep quality in the control group were consistent with the results of the above study, so that the mean score of sleep quality of pregnant women increased from 9.26 in the rst quarter to 11.47 in the third quarter. However, spiritual-oriented counselling reduced the overall score of sleep quality from 9.45 to 5.40. Therefore, using the present approach can be considered as a basis for improving sleep quality during pregnancy.
Religious activities can be a social determining factor in the state of sleep. So those who engage in the religious activity are more likely to have a healthy sleep than those who do not. Based on the conceptual model proposed in a study, religious con ict may increase with hope, better support for mental health, a healthy lifestyle, reduced stress, healthier physiological function, limited substance use, and exposure to stress leading to healthy sleep (41). However, con icting results have also been reported. For example, Gillum et al. (2013) showed that there was no signi cant relationship between participation in religious ceremonies in people over 40 years of age and sleep disorders (42), the results of which are inconsistent with the results of the present study because of the difference in the research population.
The results of the present study showed that spiritual content counselling was effective in improving the severity of insomnia in pregnant women. In the intervention group, the mean score of insomnia severity before the intervention decreased from 7.05 to 1.55 in the third trimester, and in the control group, it increased from 7.05 to 12.63. Comparing the mean scores in the three time periods between the two groups was signi cant. So far, many interventions have been made to treat insomnia in pregnant women, but due to the adverse effects of drugs in pregnancy, researchers are trying to focus on nonpharmacological methods. The results of the present study are consistent with the results of some nonpharmacological interventions. As Jalal Marvi et al. showed (2019), distance education has positive effects on improving the intensity of insomnia in pregnant women (43). In another study, Felder et al.
(2020) showed that the implementation of 6 sessions of digital counselling based on the cognitivebehavioural approach could alleviate the intensity of insomnia in pregnant women (40). Tomfohr-Madsen et al. reported similar results in 2017. In their study, holding 5 group counselling sessions based on the cognitive-behavioural approach had positive effects on alleviating the intensity of insomnia in pregnant women in the second trimester of pregnancy (44). The ndings of our study showed that integration of sleep hygiene training with spiritual orders can be as effective as other interventions.
It can be argued that some cognitive patterns, psychological characteristics, and behavioural patterns created by spiritual-oriented methods lead to improved health and improved physiological function of the body, followed by high psychological resistance in inappropriate physical and social situations. Accordingly, religious and spiritual practices lead to increased tolerance, patience, self-control, positivism, satisfaction, emotional control, optimism, self-e cacy (based on trust in God's blessing), altruism, kindness, and love (34). The skill of "spiritual resilience" is another technique of spiritual counselling that encourages the audience to overcome physical and mental problems in a variety of ways .The present study had several limitations. Data collection was performed using a self-report questionnaire and all participants were Muslim which should be considered in the generalizability of our ndings.

Implications for Practice and/or Policy
In the present study, the effects of spiritual content counselling were not signi cant on habitual sleep e ciency. Given the importance of sleep in the physical and mental health of pregnant mothers, it is recommended that educational programs be conducted using other psychological approaches in this eld.

Conclusion
The results of the present study showed that counselling with a spiritual content could effectively ameliorate sleep quality and reduce the insomnia severity in pregnant mothers. Also, improving sleep quality continued until the third trimester of pregnancy. However, the control group had worse sleep quality with increasing gestational age than the intervention group. It seems that the approach of the present study is an acceptable basis to design intervention programs in this eld that can be considered by researchers, consultants, and midwives.

List Of Abbreviations
The Pittsburgh Sleep Quality Index (PSQI)   Figure 1 Chart of participant's enrollment and procedure Chart of Insomnia severity index (ISI) in two groups