CRITICAL APPRAISAL SKILL PROBLEM Nama : PRIMA ALFIANITA NIM : P1337420616019 1. The Effect Of Religious Intervention on the level of Comatose Patients Hospitalized In Intensive Care Unit Pertanyaan Fokus Yes No Unknown Keterangan Bagian A: Apakah hasilnya valid? 1. Apakah studi tersebut v Penelitian ini menjelaskan secara fokus? menunjukkan fokus (Studi populasi, intervensi, masalah tepat. kelompok Dapat dilihat dari abstrak control/intervensi, hasil) yang tertera dalam jurnal penelitian. yang Penelitian mengenai pemberian religi Efek intervensi terhadap status kesadaran pasien koma. Desain studi, populasi, sample intervensi kelompok control/intervensi dan hasil dijelaskan cukup detail. 2. Apakah pembagian pasien ke dalam intervensi kelompok dan control v Berdasarkan jurnal tersebut, kelompok control dan intervensi dilakukan secara (bagaimana apakah acak dilakukan secara acak. dilakukan, alokasi dilakukan Alokasi pasien pasien dijelaskan sejumlah 66 secara pasien dimana 33 orang tersembunyi oleh peneliti masuk ke dalam dan pasien) kelompok control dan 33 orang lainnya menjadi kelompok intrevensi 3. Apakah yang semua terlibat penelitian akan dengan benar kesimpulan dihentikan pasien v dalam dicatat nilai GCS nya. dicatat Karena data yang di ditampilkan sudah (apakah lebih Tidak semua pasien dalam bentuk rata rata. awal apakah pasien dianalisis dalam kelompok untuk yang mereka acak) 4. Apakah pasien, petugas kesehatan, dan respondenn pada penelitian ini “blind” v Tujuan dan manfaat studi dijelaskan kepada semua keluarga, kerabat, dan wali sah dari terhadap intervensi yang peserta Keluarga sampel dilakukan yang berpartisipasi dalam penelitian ini, keluarga/wali menandatangani informasi formulir persetujuan, secara sadar. Untuk pencegahan bias, sampel intervensi dan kelompok kontrol menggunakan headphone dan pemutar MP3. 5. Apakah pelaksanaan untuk Kelompok intervensi v setiap grup sama? diberikan murotal AlQur’an dan medikasi lainnya sementara kelompok control hanya mendapatkan pengobatan medis. . 6. Selain intervensi dilaksanakan yang v apakah Tidak dijelaskan secara mendetail apakah setiap grup diperlakukan setelah penelitian selesai dengan adil/sama? kelompok control mendapat perlakuan yang sama. Bagian B: Apa Hasilnya? 1. Seberapa Besar efek dari v Studi ini melaporkan intervensi tersebut pengaruh (outcome, hasilnya agama pada pasien koma dijelaskan spesifik, hasil yang dirawat di ICU yang ditemukan, hasil dari Rumah setiap Modarres diukur outcome yang intervensi Sakit Shahid di Saveh melalui stimulasi murotal Al Qur’an. Hasil penelitian menunjukkan bahwa tingkat kesadaran ratarata dalam intervensi kelompok sebelum intervensi 3,73 ± 0,63 dan setelah intervensi adalah 7,82 ± 1,40 (P = 0,01) dan kelompok awal pada kontrol dan di akhir penelitian, masing- masing 3,52 ± 0,67 dan 5,36 ± 1,6 (P = 0,09). Setelah 10 hari, tingkat kesadaran dalam intervensi kelompok meningkat secara signifikan (P = 0,01). Penelitian ini menunjukkan bahwa suara Al-Quran mempengaruhi tingkat kesadaran pasien koma yang dirawat di rumah sakit di ICU dan mengarah ke peningkatan progresif di tingkat kesadaran pada pasien ini. penelitian ini digunakan manajemen klinik Hasil dapat dalam pasien serta di dalam Pendidikan keperawatan. Perawatan spiritual dianggap sebagai perawatan yang komprehensif 2. Seberapa tepat dan akurat v efek intervensi? Penelitian ini tepat dilaksanakan berkaitan dengan agama yang dianut oleh klien. Sementara keakuratan efek intervensi sebenarnya sudah dijelaskan di jurnal, namun masih ada kekurangan yaitu tidak dicantumkannya hasil pengukuran GCS setiap pasien baik sebelum dan sesudah intervensi. Bagian C: Apakah hasil membantu secara local? 1. Bisakah hasilnya v Hasil penelitian bisa diterapkan pada populasi diterapkan pada kondisi local, atau konteks saat ini saat ini karena yang di lingkungan sekarang menjadi syarat utama (apakah adalah pasien beragama karaketristik pasien sama dengan tempat bekerja/populasi islam. perbedaan yang mendaasar adalah anda, jika berbeda, apakah budaya tempat peneltian perbedaannya) yaitu di Iran. Sementara penelitian saya diencanakan akan dilaksanakan di Indonesia. 2. Apakah hasil penelitian ini v Hasil penelitian ini penting secara klinis untuk penting secara klinis dipertimbangkan (apakah untuk dipertimbangkan. informasi Terapi murotal ini dapat yang anda inginkan sudah terdapat memberikan efek yang dalam penelitian ], jika cukup signifikan pada tidak tingkat kesadaran pasien apakah berpengaruh akan terhadap yang mengalami koma. pengambilan keputusan) Namun ada beberapa informasi yang belum tercantum yaitu nilai GCS masing-masing pasien sebelum dan sesudah intervensi maupun pada kelompok control, karena dalam jurnal tersebut sudah ditampilkan dalam bentuk rata-rata (mean) 3. Apakah manfaatnya v Pada penelitian ini tidak sepadan dengan bahaya ditemukan dan biaya yang dibutuhkan membahaykan (meskipun tidak pasien. tercantum dalam penelitian , menurut anda? bagaimana effek bagi Lampiran Jurnal Accepted Manuscript Title: The effect of religious intervention on the level of consciousness of comatose patients hospitalized in Intensive Care Unit: A randomized clinical trial Authors: Vahid Naseri-Salahshour, Shokoh Varaei, Mahbobeh Sajadi, Setareh Tajdari, Masoumeh Sabzaligol, Neda Fayazi PII: DOI: Reference: S1876-3820(18)30124-0 https://doi.org/10.1016/j.eujim.2018.06.008 EUJIM 813 To appear in: Received date: Revised date: Accepted date: 12-4-2018 22-6-2018 22-6-2018 Please cite this article as: Naseri-Salahshour V, Varaei S, Sajadi M, Tajdari S, Sabzaligol M, Fayazi N, The effect of religious intervention on the level of consciousness of comatose patients hospitalized in Intensive Care Unit: A randomized clinical trial, European Journal of Integrative Medicine (2018), https://doi.org/10.1016/j.eujim.2018.06.008 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. The effect of religious intervention on the level of consciousness of comatose patients hospitalized in Intensive Care Unit: A randomized clinical trial Running title: The effect of religious intervention on the level of consciousness Author(s): Vahid Naseri-Salahshour1, Shokoh Varaei2*, Mahbobeh Sajadi3, Setareh Tajdari4, Masoumeh Sabzaligol5, Neda Fayazi6 Affiliations: 1 MSc of Medical Surgical Nursing, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran. Email: [email protected] 2 Assistant professor, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Email: [email protected] 3 Assistant professor, School of Nursing and Midwifery, Arak University of Medical Sciences, Arak, Iran. Email: [email protected] 4 MSc of Medical Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Email: [email protected] 5 MSc of Medical Surgical Nursing, School of Nursing and Midwifery, Tehran University of Medical Sciences, Tehran, Iran. Email: [email protected] 6 MSc of Critical Care Nursing, School of Nursing and Midwifery, Saveh University of Medical Sciences, Saveh, Iran. Email: [email protected] * Corresponding Author Shokoh Varaei, Ph.D. of Nursing Education, Tehran University of Medical Science, Tehran, Iran. Address: School of Nursing and Midwifery of Tehran University of Medical Sciences, Nosrat St, Tohid Sq, Tehran, Islamic Republic of Iran (IRI). Phone numbers: 0098 21 66914368 E-mail address: [email protected] Fax number: 0098 86 42302967 Clinical Trial registration number: IRCT2016122331522N1 Abstract Introduction: The Qur'an is regarded as the central religious text of Islam and referred to as the celestial book of Muslims that covers the entire dimensions of human life.The aim of this study was to determine the religious intervention on the level of consciousness of the comatose patients hospitalized in the Intensive Care Unit. Methods: This randomized clinical trial was performed with 66 comatose patients hospitalized in the Intensive Care Unit who were randomly divided into intervention and control groups. For the samples of the intervention group, Surah Raad, with the voice of Master Shahriyar Parhizgar, was broadcast daily for 17 minutes via headphones. The level of consciousness of both groups was recorded before and after the intervention. Results: By comparing the changes in the level of consciousness in patients in both groups, there was no significant difference between the mean level of consciousness in the both groups before intervention (P=0.13). After 10 days, the level of consciousness in the intervention group increased significantly (P=0.01). But, the increase in level of consciousness in the control group after intervention (10 days) was not significant (P=0.09). Conclusion: The results showed Quran sound can improve the level of consciousness of comatose patients. Therefore, it can be used as an easy and practical way to employ the spiritual care of patients. Keywords: religious intervention; level of consciousness; comatose patients; intensive care unit; randomized clinical trial 1. Introduction Coma is a condition in which the patient has been long unaware of himself and the environment, and is a dream-like condition that the eyes are closed. The causes of coma can be divided into two categories, neurological causes including: meningeal irritation due to infection or hemorrhage in the arachnoid space, massive hemiplegic and brain stem lesions, stroke and metabolic causes including: vitamin deficiency, uremia, liver encephalopathy, elevated levels of carbon dioxide, alcohol and drug poisoning, hypothyroidism and hyperthyroidism, and water, electrolyte and acidic and alkaline disorders. In this case, the person is exposed to many possible complications, including respiratory failure, pneumonia, pressure ulcers, and aspiration and sensory deprivation (1). The most common cause of coma in Iran and the world is injuries and a variety of poisoning. According to present statistics, more than 811 people per 100 000 people in Europe suffer from head injuries each year (2). According to the available evidence, in Iran, 3,300 people die annually due to motor injuries (3). Considering the complications of long-term inertia and high cost for the patient and the health system, the rapid recovery of these patients is very important (4). Hospitalized patients have physical needs in addition to spiritual needs, which can affect the patient's recovery (5). Spirituality is an essential component of health and well-being(6). In the last decade, some medical team members, psychologists, nurses and sociologists have found that spirituality can have a significant impact on various aspects of medical care (7-9). In this regard, we can mention the study of Sajjadi et al. (10). The study found that spiritual counseling had a positive impact on the health and well-being of cancer patients. Another study by Darabi Nia et al. found that recitation of the Qur'an led to an improvement in the mental health of health personnel (11). Today, the role of spirituality in improving the health of the patient is more focused and helping to meet the spiritual needs of patients and their families is considered as an essential element of clinical care (12). Paying attention to the spiritual needs of patients is an integral part of comprehensive nursing care (13). Spiritual care is one of the essential components of nursing practice (14, 15). Florence Nightingale believes that the nurse plays an important role in improving the patient's health, taking into account the mental and psychological aspects of the patient (16). The American Nursing Association has also considered the spiritual dimension as a nursing examination center in expressing clinical practice standards (17). Therefore, nurses should perform their duties with regard to the spiritual aspects of the patient and respect for the patient's values and beliefs. In addition to other nursing interventions, spiritual intervention will balance the body and soul and provide a comprehensive step for health. One of the spiritual interventions in the treatment of patients is the use of the voice of the Holy Qur'an. The Qur'an is a celestial book of Muslims that covers the entire dimensions of human life, and treatment of illnesses can be the next dimension of the countless Qur’an dimensions. Muslim scholars have used divine verses to treat patients, and in religious texts of Muslims, they have also emphasized the healing effects of Quran verses (18, 19). One of the most beautiful, most enjoyable, attractive and most natural music is the recitation of the Holy Quran. The undisputed effect of this Divine Blessing in the treatment of diseases is to a point where, today, some countries and communities have turned to Prayer and Quran for the treatment of patients' mental and physical illnesses, as is now scientifically proven. That hearing the sound of the holy Qur'an can reduce mental stress in human (20). In this case, Sabry et al. showed that the Qur'an can be used to treat various psychiatric disorders in patients (21). Now Quran therapy is an active and growing process in various countries (22). Since hearing is the strongest sensation of the five senses and the last sensation that is lost in comatose patients (23), we decided to examine the effect of Quranic voice on the level of consciousness in patients with coma condition. Therefore, the purpose of this study was to determine the effect of the religious intervention on the level of consciousness of the comatose patients hospitalized in the intensive care unit (ICU). 2. Methods 2.1. Study design and setting This study is a double-blind randomized clinical trial was performed on 66 comatose patients hospitalized in ICU of Shahid Modarres Hospital in Saveh (Iran). The samples were as homogeneous in terms of level of consciousness and cause of coma. 2.2. Data collection After obtaining consent form from first degree relatives (father, mother or legal guardian) samples were selected by available method and were randomly assigned to two groups of intervention (n=33) and control (n=33) using blocking method. The inclusion criteria includes: level of consciousness between 3 and 5 according to Glasgow's Coma Scale, 48 hours after hospitalization, 20 - 60 years old, no previous history of hospitalization in ICU, no severe change in the shape of face, patients with opioid poisoning, head trauma and intracerebral hemorrhages, and belief to the religion of Islam, and exclusion criteria includes: patient discharge before the tenth day, the transfer of the patient to another health center, surgery after the first 24 hours, uunwillingness of the patient's family, patients death and hearing impairment. 2.3. Measurement scales The instruments used in this study were the Demographic Questionnaire and the Glasgow Coma Scale. The Glasgow Coma Scale (GCS) is a standard scale that consists of three subgroups of motor response, verbal response and eye contact. GCS is a neurological scale which aims to give a reliable and objective way of recording the conscious state of a person for initial as well as subsequent assessment (24) (Table 1). 2.4. Ethical approval It should be noted that the present study was approved by the Ethics Committee of Tehran University of Medical Sciences with the code of: IR.TUMS.FNM.REC.1395.1042 and registered in the Iranian Registry of Clinical Trials. The aims and benefits of study explained to all families, relatives, and legal guardians of participants. The families of samples who are participated in this study, signed an informed consent form, consciously. 2.5. Intervention 48 hours after the hospitalization, intervention was initiated. At first, patients' level of consciousness was measured using the GCS. Then, for the patients in the intervention group, along with the standard care, daily for 17 minutes (up to 10 days), the verses of Sura Raad was broadcast through headphones with the voice of Master Shahriyar Parhizgar (23). The reason for using surah Raad verses in this research was the meaning of the verses. After completing the recite of the Holy Quran verses, again the level of consciousness of the patients was examined. In the control group, standard care was also performed. It should be noted that for prevention of bias, both the intervention and control group samples used headphones and MP3 players, with the difference that in the control group, the device did not recite Quranic verses or did not broadcast any other music. The demographic information questionnaire was completed by interviewing with the patients' families and using the medical documents of the patients. 2.6. Data analysis Statistical analysis was conducted using SPSS version 16. Descriptive statistics are presented as means and standard deviations for quantitative variables and as frequencies and percentages for categorical variables. A Kolmogorov-Smirnov (K-S) test was conducted to ensure that the data were normally distributed. An independent t-test and chi-square or Fisher's tests were used to determine statistical significant difference when comparing intervention and control patients' characteristics. Paired and independent sample t-tests were used to examine differences within and between the intervention and control groups. The α level was set a p<0.05 for statistical significance. Results This study reports the effect of the religious intervention on the consciousness of comatose patients hospitalized in ICU of Shahid Modarres Hospital in Saveh. In this study, 66 patients with 20-60 years old were studied. After random allocation of samples, in the first stage, 2 patients in the intervention group and 4 patients in the control group were excluded from the study. In the follow up phase, 4 patients from the intervention group and 2 patients from the control group were excluded due to transfer to the other Medical Center (CONSORT flow diagram of the participants) and finally, 33 patients remained in each group. Therefore, the response rate was 100%. The results of the study showed that 54.5% of the patients were male. The age range 51 to 60 years old and high school degree was the most frequent among them (Table 1). The results of the study showed that the mean level of consciousness in the intervention group before intervention was 3.73±0.63 and after intervention was 7.82±1.40 (P=0.01) and in the control group at the beginning and the end of the study, 3.52±0.67 and 5.36 ± 1.6 respectively (P=0.09). By comparing the changes in the level of consciousness in patients in both intervention and control groups, there was no significant difference between the mean level of consciousness in the intervention and control groups before intervention (P=0.13). After 10 days, the level of consciousness in the intervention group increased significantly (P=0.01). But, the increase in level of consciousness in the control group after intervention (10 days) was not significant (P=0.09) (Table 2). Discussion The results showed that the mean level of consciousness in the intervention group before intervention was 3.73±0.63 and after intervention was 8.82±1 (P=0.01). In the study of Hassanzadeh et al., The results showed the positive effect of familiar stimuli on improving the level of consciousness of patients with head injuries hospitalized in ICU from 7±2 in the first day to 11.6±6.2 in the sixth day. The results showed an increased level of consciousness in these patients. The results of this study are consistent with the results of their study (4). The results showed that the mean level of consciousness in the control group at the beginning and the end of the study was 3.52±0.62 and 5.36±1.6 (P=0.09). Although the level of consciousness increased, this increase was not significant. In this regard, Hassanzadeh et al. showed that the level of consciousness in the first and sixth day was 7±7 and 7±2 in the control group, that was not significant (4). The our study showed that there was no significant difference between the mean level of consciousness in the intervention and control groups before intervention (P=0.13), but after 10 days, level of consciousness in both groups increased, but changes in consciousness were significant in the intervention group (P=0.01), while in the control group, these changes were not significant (P=0.09). Shirvani et al. in their study showed that the broadcast of the Quran Voice can cause balance the blood pressure and arterial oxygen pressure of patients hospitalized in ICU (23). Also, the results of Heidari et al. study showed a positive effect of Quranic and indifferent music on reducing the anxiety level of patients under endoscopy (25). These findings are consistent with the results of Goodarzi et al. Their study showed that auditory stimulation with familiar sounds significantly increased the level of consciousness of patients (26). The results of this studies are consistent with the results of our study. Many studies have been done on the effects of the Holy Quran on human health and the treatment of physical and mental illness. The results of these studies have shown that listening to Qur’an voices has been effective on the balance of vital signs and increased oxygen pressures in ICU patients (23). In a study, Mirbagher et al. examined the effect of Quran voice and music on the anxiety and vital signs of patients before abdominal surgery (27). The results of their study showed that music (Voice of Nature) and Quran Voice were both effective in decreasing the anxiety and vital signs of the patients, but the Quran voice was more effective. In a study Momeni et al., examined the relationship between familiarity with Quran and death anxiety in nurses in the emergency department of Vali-e-Asr Hospital in Arak. Results showed a negative relationship between familiarity with Quran and the death anxiety of emergency department nurses, but this was not significant (P=0.47) (28). Majidi et al. in a study examined the effect of Quran verses on the anxiety of patients before coronary angiography. The results showed a significant reduction in anxiety level in patients undergoing angiography. These results are consistent with the results of our study. Spirituality is a complex concept and its definition depends on the individual's worldview (10). Spirituality and religion are the primary sources of conformity and are often characterized by prayer and dependence on God (10). The Holy Qur'an contains many verses about achieving peace. The recitation of the Qur'an causes the peace of mind (28). God says in the Qur'an: “remembering me will bring peace to your heart”. Spiritual care is a vital component of comprehensive care, but is often neglected and there is little information in the various texts about spiritual-centered interventions (29). Targeted sensory stimuli for comatose patients, including spiritual care, are essential in the ICU have been neglected (4). Since Iran is a religious country and the majority of its population as Muslims, the use of spiritual care as a branch of comprehensive nursing care can be effective in improving ICU patients' health (27). Nurses as professionals should enter spirituality in their care program. Getting spiritual history, paying attention to the religious beliefs of the patients and their families, and providing spiritual care to them is a way to provide comprehensive nursing care (30). Limitations This study has some limitations. Because the Qur'an is the Muslim scripture, and this study was conducted only by Muslim patients from an Iranian cultural background. The results cannot be therefore be generalized to other Muslim populations nor to other religions. In addition, the sample size is comparatively small, so the present findings must be confirmed in a larger study. Conclusion and implications for practice The findings of this study showed that the Quran's voice affects the level of consciousness of comatose patients hospitalized in ICU and leads to a progressive increase in the level of consciousness in these patients. This finding can be used in the management of patients in nursing clinics, as well as in nursing education. Spiritual care is considered as comprehensive nursing intervention. At present, this issue is neglected due to the heavy workload of nurses. Thus, nursing care with additional spiritual intervention services is imperative for supporting comatose patients’ hospitalized in Intensive Care Unit. Funding The study was supported by: Vice-Chancellor for Research of Tehran University of Medical Sciences. Conflict of interest None of the authors have any conflicts of interest. Acknowledgements The present study is the result of a research project approved by the Tehran University of Medical Sciences. The authors would like to thank the Vice-Chancellor for Research, honorable masters of Nursing and Midwifery faculty and all patients who participated in this study and their families. References 1. Morton PG, Fontaine D, Hudak C, Gallo B. 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Figure: Figure 1 :CONSORT flow diagram of the participants Tables: Table 1: The items of the Glasgow Coma Scale Items Eye opening Score 6 5 4 3 2 1 N/A N/A Open before stimulus (Spontaneous) After spoken or shouted request After fingertip stimulus (To sound) (To pressure) No opening at any time, no interfering factor (None) Verbal response N/A Correctly gives name, place and date (Orientated) Not orientated but communication coherently (Confused) Intelligible single words (Words) Only moans / groans (Sounds) No audible response, no interfering factor (None) Motor response Obey 2-part request (Obeys commands) Brings hand above clavicle to stimulus on head neck (Localizing) Bends arm at elbow rapidly but features not predominantly abnormal (Normal flexion) Bends arm at elbow, features clearly predominantly abnormal (Abnormal flexion) Extends arm at elbow (Extension) No movement in arms / legs, no interfering factor (None) Table 2: Demographic information of the intervention and control group samples Group Variable Intervention (n=33) Age (year) Mean±SD 45.6±7.2 Category Frequency (%) Sex Single 19 (28.7) Married 14 (21.2) Level 5 (7.5) Illiterate of education Primary education 9 (13.6) High school degree 12 (18.7) 17 (10.6) Academic education Occupational status Religion (one of the two main branches of Islam) Unemployed Employee Self-employment Others Shia Sunni Control (n=33) 42.7±6.2 Frequency (%) 17 (25.7) 16 (24.2) 4 (6.06) 6 (9.09) 13 (19.6) 10 (15.1) 2 (3.03) 10 (15.1) 8 (12.1) 13 (19.6) 29 (43.9) 1 (1.5) 13 (19.6) 8 (12.1) 11 (16.6) 25 (37.8) 4 (6.06) 8 (12.1) p 0.96 0.41 0.93 0.48 0.89 Table 3 Mean, standard deviation (SD) and significant level of consciousness of the groups before and after the intervention Group Variable time Intervention (n=33) Control (n=33) Mean±SD p Mean±SD level of consciousness Before intervention 3.73±0.63 0.1 3.52±0.62 After intervention 8.82±1.4 0.01 5.36±1.6 p 0.1 0.09