Coronary Artery DiseaseNCT06346990
The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG
A study testing Holy Quran Recital in people with Coronary Artery Disease and Coronary Artery Bypass Graft Surgery, run by Applied Science Private University.
Trial summary
This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Bypass Graft Surgery, Delirium, Postoperative
- What is being tested?
- Holy Quran Recital
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 15 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and older;
- undergone elective CABG surgery;
- hemodynamically stable during interventions and interviews;
- signed an informed consent
Who cannot join
- Developed delirium before the intervention based on Confusion Assessment Method for the Intensive Care Unit (CAM-ICU);
- Had a history of liver cirrhosis, kidney failure, stroke, dementia, or psychiatric problems;
- On anti-antipsychotic medications; or
- Received treated with ketamine or midazolam in the operating room or benzodiazepines, haloperidol, and propofol in the intensive care unit (ICU), as they are known to increase susceptibility for hallucination and delirium.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG: A Randomized Control Trial
This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the effect of Holy Qoyran on this outcome.
Read the detailed description
Coronary artery disease is a very common cardiovascular disease nationwide. Coronary artery bypass graft surgery (CABG) is a surgical treatment for coronary artery disease. This surgery has positive outcomes for the patients compared to other revascularization procedures including lower levels of re-infarctions, better quality of life, extend patients' lives and reduction of revascularization procedures. Despite these benefits, CABG is a major surgery that has its own risks and complications, like bleeding, wound infection, extended use of mechanical ventilation, cardiac dysthymias, stroke, pulmonary edema, death, and development of post-operative delirium. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) describes delirium as a transient mental syndrome that is characterized by three main symptoms: "(a) Disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment), (b) The disturbance develops over a short period of time (usually hours to a few days), represents an acute change from baseline attention and awareness, and tends to fluctuate in severity during the course of a day, (c) An additional disturbance in cognition (e.g. memory deficit, disorientation, language, visuospatial ability, or perception)." There is also a need for evidence from physical exam and laboratory findings that these changes are not due to other conditions like drug abuse, withdrawal symptoms, or the use of medications.9 Delirium is a common complication after CABG with high incidence rates ranging from 3% to 75%. These high rates are linked to a number of negative outcomes, including self-extubation, respiratory failure, sternal instability, an extended hospital stay, higher (readmissions, medical expenses, and mortality rates) and lower quality of life. Even though delirium is common and has detrimental clinical effects, medical professionals and staff frequently fail to recognize it. According to earlier research, between 32% and 84% of delirium cases go undetected by medical professionals. Most of delirium cases occur after major and long surgeries like CABG, not after minor surgeries. These results indicate that the pathophysiology of postoperative delirium may be significantly influenced by anxiety, stress and depressive responses brought on by surgical stimulation has been reported that stress, anxiety and depression were high in the per-operative period and were associated negative outcomes as increased length of stay and occurrence delirium. Primary prevention of delirium entails reducing effective risk factors such environmental interventions, while secondary prevention involves early diagnosis. Increasing or lowering environmental stimulation, medicine, and music therapy are some strategies to lower the frequency of delirium. Fortunately, delirium is a sickness that can be avoided. Instead of treating this illness, researchers have recently concentrated more on risk factor identification and prevention. Therefore, investigations involving medications like melatonin, reduction of sedative medications as benzodiazepines, and surgical methods were conducted with the aim of preventing these postoperative morbidities; however, the results have been inconclusive.
Consequently, non-pharmacological intervention to control delirium after CABG were studied like the use of music and education. These non-pharmacological interventions work through the hypothesis that they will regulate the effect of anxiety, stress and depression resulting in reducing heart rate, blood pressure, and pro-inflammatory cytokines. In addition, previous studies showed a connection between non-pharmacological interventions and reduction of postoperative pain, and serum cortisol levels which in turn reduced the occurrence of delirium. However, none of these studies was designed specifically to check the effect of listing to Holy Quran on the incidence of delirium post CABG, which might be working through the same mechanism. Among patients how did CABG, previous studies demonstrated that holy Quran audio therapy was significantly associated with reduction of anxiety and depressive symptoms.1,36 Moreover, listening to holy Quran recital significantly decreased pain and length of stay. Also, with regard to patients with heart problems other than CABG, Quran audio therapy has been shown to reduce anxiety before cardiac catheterization procedures, and enhance sleep quality following other cardiac surgeries. Research questions: (1) what is the incidence of delirium post CABG, (2) what is the effect of listing to holy Quran on the incidence of delirium post CABG, (3) what is the effect of listing to holy Quran on the length of stay post CABG, and (4) what is the effect of delirium on the length of stay (LoS) post CABG.
- Being tested
- Holy Quran Recital
- Keywords
- Delirium, length of stay
- Medical subject headings
- Coronary Artery Disease, Emergence Delirium, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holy Quran RecitalOther
Holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each
| Study group | Role | What they receive |
|---|---|---|
| The intervention group/ Holy Quran Recital | Experimental | For the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they received holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium. Receives: Other: Holy Quran Recital |
| The control group | No intervention | For the control group, routine post-operative care was done |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium
The effect of holy quran recital on the incidence of delirium
Measured: Within one week after the operation
Secondary outcomes (2)
Length of stay-ICU
The effect of holy quran recital on the length of stay in the ICU
Measured: Within one week after the operation
Length of stay-hospital
The effect of holy quran recital on the length of stay in the hospital
Measured: Within two week after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion14 Apr 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups in this study. The intervention group and the control group. For the control group, patients are receiving routine care . For the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they receive holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohannad Aburuz, Applied Science Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346990
- Sponsor's protocol ID
- Faculty 2023-2024-2-2
- Status last verified
- Apr 2024
- First submitted
- 29 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Holy Quran Recital on the Incidence of Delirium Post-CABG: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06346990
- Acronym / sponsor ID
- Faculty 2023-2024-2-2
- Keywords
- Delirium, length of stay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 14 Apr 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned to check the effect of holy Quran recital on the development of delirium after conronary artery bypass graft surgery (CABG). Different studies have been done before about the effects of non-pharmacological intervention on delirium after CABG, howvere, none was designed specifically to check the effect of Holy Qoyran on this outcome.
Detailed description
Coronary artery disease is a very common cardiovascular disease nationwide. Coronary artery bypass graft surgery (CABG) is a surgical treatment for coronary artery disease. This surgery has positive outcomes for the patients compared to other revascularization procedures including lower levels of re-infarctions, better quality of life, extend patients' lives and reduction of revascularization procedures. Despite these benefits, CABG is a major surgery that has its own risks and complications, like bleeding, wound infection, extended use of mechanical ventilation, cardiac dysthymias, stroke, pulmonary edema, death, and development of post-operative delirium. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) describes delirium as a transient mental syndrome that is characterized by three main symptoms: "(a) Disturbance in attention (i.e., reduced ability to direct, focus, sustain, and shift attention) and awareness (reduced orientation to the environment), (b) The disturbance develops over a short period of time (usually hours to a few days), represents an acute change from baseline attention and awareness, and tends to fluctuate in severity during the course of a day, (c) An additional disturbance in cognition (e.g. memory deficit, disorientation, language, visuospatial ability, or perception)." There is also a need for evidence from physical exam and laboratory findings that these changes are not due to other conditions like drug abuse, withdrawal symptoms, or the use of medications.9 Delirium is a common complication after CABG with high incidence rates ranging from 3% to 75%. These high rates are linked to a number of negative outcomes, including self-extubation, respiratory failure, sternal instability, an extended hospital stay, higher (readmissions, medical expenses, and mortality rates) and lower quality of life. Even though delirium is common and has detrimental clinical effects, medical professionals and staff frequently fail to recognize it. According to earlier research, between 32% and 84% of delirium cases go undetected by medical professionals. Most of delirium cases occur after major and long surgeries like CABG, not after minor surgeries. These results indicate that the pathophysiology of postoperative delirium may be significantly influenced by anxiety, stress and depressive responses brought on by surgical stimulation has been reported that stress, anxiety and depression were high in the per-operative period and were associated negative outcomes as increased length of stay and occurrence delirium. Primary prevention of delirium entails reducing effective risk factors such environmental interventions, while secondary prevention involves early diagnosis. Increasing or lowering environmental stimulation, medicine, and music therapy are some strategies to lower the frequency of delirium. Fortunately, delirium is a sickness that can be avoided. Instead of treating this illness, researchers have recently concentrated more on risk factor identification and prevention. Therefore, investigations involving medications like melatonin, reduction of sedative medications as benzodiazepines, and surgical methods were conducted with the aim of preventing these postoperative morbidities; however, the results have been inconclusive.
Consequently, non-pharmacological intervention to control delirium after CABG were studied like the use of music and education. These non-pharmacological interventions work through the hypothesis that they will regulate the effect of anxiety, stress and depression resulting in reducing heart rate, blood pressure, and pro-inflammatory cytokines. In addition, previous studies showed a connection between non-pharmacological interventions and reduction of postoperative pain, and serum cortisol levels which in turn reduced the occurrence of delirium. However, none of these studies was designed specifically to check the effect of listing to Holy Quran on the incidence of delirium post CABG, which might be working through the same mechanism. Among patients how did CABG, previous studies demonstrated that holy Quran audio therapy was significantly associated with reduction of anxiety and depressive symptoms.1,36 Moreover, listening to holy Quran recital significantly decreased pain and length of stay. Also, with regard to patients with heart problems other than CABG, Quran audio therapy has been shown to reduce anxiety before cardiac catheterization procedures, and enhance sleep quality following other cardiac surgeries. Research questions: (1) what is the incidence of delirium post CABG, (2) what is the effect of listing to holy Quran on the incidence of delirium post CABG, (3) what is the effect of listing to holy Quran on the length of stay post CABG, and (4) what is the effect of delirium on the length of stay (LoS) post CABG.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups in this study. The intervention group and the control group. For the control group, patients are receiving routine care . For the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they receive holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium
| Arm | Type | Receives |
|---|---|---|
| The intervention group/ Holy Quran Recital | Experimental | Other: Holy Quran RecitalFor the intervention group, after patients were (1) extubated, (2) hemodynamically stable, and (3) negatively rated on primary CAM-ICU, they received holy Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each. We choose these times based on the nurses' recommendations about the minimal interruptions from physician rounds and family visits. The selection of Surah Al-Rahman was based on the widespread belief that it is among the most melodic and calming passages in the Quran, especially when recited by the well-known reciter Qari AbdulBasit. 1,5,40 The listening was done using one-use headphones on an iPad. The intervention was discontinued if the participant developed delirium. |
| The control group | No intervention | –For the control group, routine post-operative care was done |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old and older;
- undergone elective CABG surgery;
- hemodynamically stable during interventions and interviews;
- signed an informed consent
Key exclusion criteria (4 listed)
- Developed delirium before the intervention based on Confusion Assessment Method for the Intensive Care Unit (CAM-ICU);
- Had a history of liver cirrhosis, kidney failure, stroke, dementia, or psychiatric problems;
- On anti-antipsychotic medications; or
- Received treated with ketamine or midazolam in the operating room or benzodiazepines, haloperidol, and propofol in the intensive care unit (ICU), as they are known to increase susceptibility for hallucination and delirium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holy Quran RecitalHoly Quran recital for four days. Typically, the second, third, fourth- and fifth-days following CABG. The daily sessions were done at 2 PM and 8 PM for 20 minutes each | Other | The intervention group/ Holy Quran Recital |
Primary outcome
Delirium
Time frame: Within one week after the operation
The effect of holy quran recital on the incidence of delirium
2 secondary outcomes
Length of stay-ICU
Time frame: Within one week after the operation
Length of stay-hospital
Time frame: Within two week after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Holy Quran Recital in people with Coronary Artery Disease and Coronary Artery Bypass Graft Surgery, run by Applied Science Private University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohannad E. AbuRuz, PhD (+962790192494, m_aburuz@asu.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium (time frame: Within one week after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.