Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06346990 |
| Other study ID # |
Faculty 2023-2024-2-2 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 15, 2024 |
| Est. completion date |
May 15, 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Applied Science Private University |
| Contact |
Mohannad E. AbuRuz, PhD |
| Phone |
+962790192494 |
| Email |
m_aburuz[@]asu.edu.jo |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 effect of Holy Qoyran on this outcome.
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.
