Patient Depression, Anxiety, Stress and PainNCT05419544
The Effect of Listening to Holy Quran Recital on Depression, Anxiety and Stress Post CABG
A study testing Holy Quran Recital effect in people with Patient Depression, Anxiety, Stress and Pain, run by Applied Science Private University at 2 sites in Jordan.
Trial summary
Coronary artery bypass graft (CABG) is one of the most common surgical treatments for coronary artery disease. CABG has many beneficial outcomes for patients. However, there are diverse factors that hinder these positive outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Depression, Anxiety, Stress and Pain
- What is being tested?
- Holy Quran Recital effect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesJordan
- Study dates
- Jun 2022to Dec 2022
- 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
- Aged 18 and above,
- Elective CABG surgery,
- Able to communicate with the researcher during the intervention and the interview,
- Able to read and write Arabic,
- Welling to participate in the study and signed an informed consent,
- Not diagnosed with depression or anxiety disorders by psychiatrist as per medical records review, and
- Not on anti-anxiety or anti depressive
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Jordan2 sites, 2 recruiting
- Recruiting
AppliedSPU
Amman
Ghadeer A Dweik, +962795087119, ghadeerdweik@yahoo.com
- Not yet recruiting
Ghadeer Al Dweik
Multiple Locations
Ghadeer A Dweik, PhD, +962795087119, ghadeerdweik@yahoo.com
Ghadeer A Al Dweik, PhD
About this study
Official title: The Effect of Listening to Holy Quran Recital on Depression, Anxiety, and Stress Post CABG: A Randomized Control Trial
Coronary artery bypass graft (CABG) is one of the most common surgical treatments for coronary artery disease. CABG has many beneficial outcomes for patients. However, there are diverse factors that hinder these positive outcomes. Depression, anxiety, and stress (DAS) are considered as important factors that hinder these outcomes.
Depression is very common post CABG. Despite that high levels of depression, more than half of patients undergoing CBAG are not screened or treated well for depression. Depression has negative outcomes for patients undergoing CABG. Similarly, patients undergoing CABG complain from high levels of anxiety and stress in the pre and even in the post-operative period.Anxiety and stress might be manifested as impaired functional status, chest pain, and shortness of breath.· Furthermore, increased anxiety and stress is correlated with poorer quality of life and worse long-term psychological outcomes.It has been shown that the speed of recovery from acute cardiac events depends more on psychological factors rather than physiological ones. Therefore, it is imperative to have an appropriate management for these negative emotions to improve the outcomes of this major operation.
Read more
Treatment options for these emotions include pharmacological and non-pharmacological.
Listening to the holy Quran recital is one of the non-pharmacological treatment methods that were integrated to improve Coronary Heart Diseases Patient's DAS symptoms.
Previous studies showed that listening to the holy Quran recital was effective in reducing ADS symptoms among this population and other populations including hemodialysis, pregnant women, and smokers. However, this effect has not been checked for patients undergoing CABG.
Therefore, the purpose of this randomized control trial (RCT) is to check the effect of Holy Quran recital on ADS among patients undergoing CABG surgery
Read the detailed description
Intervention: The intervention group, listened to holy Quran recitation for 10 minutes twice a day 4 hours a part (10 am and 2 pm) for 2 consecutive days (usually the 2nd and the 3rd day post-operative) after extubation and gaining alertness. We have chosen Surah Al-Rehman because it is considered as the most rhythmic surah of the Quran and the recitation of Qari Abdul Basit is very soothing and effective as he has recited from the deep of the heart. The listing will be by a disposable head phones for an I pad for each hospital. The control group received usual care by their nurses.
Measurement of variables: Sociodemographic and clinical characteristics will be measured either by patient interview (age, gender, pain level, marital status, educational level, smoking status, and working status) or by medical records review (history of hypertension, history of diabetes mellites, history of acute myocardial infarction, left ventricular ejection fraction, and body mass index, and length of stay at the hospital). Depression, anxiety and Stress will be measured using the Depression Anxiety Stress Scale (DASS21). DASS 21 is a set of self-reported items used to measure the intensity of DAS over the week prior to administration. DASS21 is the short version of the basic 42-item questionnaire DAS S-42, developed by Lovibond and Lovibond. It consists of three seven-item scales (a total of 21 items): depression scale (DS), anxiety scale (AS), and stress scale (SS). Items are measured through a four point Likert scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Items in each scale are summed whereby higher scores indicate higher levels of DAS. A score between 0 and 4, 0 and 3, 0-7 are considered normal DAS, respectively. A score between 5 and 6, 4 and 4, 8 and 9 are considered mild DAS, respectively. A score between 7 and 10, 6 and 7, 10 and 12 are considered moderate DAS, respectively. A score between 11 and 13, 8 and 9, 13 and 16 are considered severe DAS, respectively. A score above 13, 9, 19 are considered extremely severe DAS, respectively. The reliability of DASS21 was measured using Cronbach's alpha and was reported to be good; it was 0.91 for the depression subscale, and 0.80 for the anxiety subscale. The reliability of the Arabic version of DASS21 was measured using Cronbach's alpha coefficients and was found to be 0.76 for depression, 0.75 for anxiety.
- Being tested
- Holy Quran Recital effect
- Keywords
- Holy Quran Recital, Depression, Anxiety, Stress, Pain, Length of stay, Open heart surgery, Coronary artery bypass graft
- Medical subject headings
- Anxiety Disorders, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holy Quran Recital effectBehavioural
The intervention group, listened to holy Quran recitation for 10 minutes twice a day 4 hours a part (10 am and 2 pm) for 2 consecutive days (usually the 2nd and the 3rd day post-operative) after extubation and gaining alertness. We have chosen Surah Al-Rehman because it is considered as the most rhythmic surah of the Quran and the recitation of Qari Abdul Basit is very soothing and effective as he has recited from the deep of the heart. The listing was by a disposable head phones for an I pad for each hospital. The control group received usual care by their nurses.
| Study group | Role | What they receive |
|---|---|---|
| The intervention group/ Holy Quran Recital | Experimental | The intervention group, listened to holy Quran recitation for 10 minutes twice a day 4 hours a part (10 am and 2 pm) for 2 consecutive days (usually the 2nd and the 3rd day post-operative) after extubation and gaining alertness. We have chosen Surah Al-Rehman because it is considered as the most rhythmic surah of the Quran and the recitation of Qari Abdul Basit is very soothing and effective as he has recited from the deep of the heart. The listing was by a disposable head phones for an I pad for each hospital. Receives: Behavioral: Holy Quran Recital effect |
| The control group/ Usual care by the nurse | No intervention | The control group received usual care by their nurses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, anxiety and Stress level
Depression, Anxiety, and Stress will be measured by The Depression, Anxiety, and Stress Scale (DASS21). DASS 21 is a set of self-reported items used to measure the intensity of depression, anxiety and stress. It consists of three seven-item scales (a total of 21 items): depression scale (DS), anxiety scale (AS), and stress scale (SS). Items are measured through a four point Likert scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Items in each scale are summed, whereby higher scores indicate higher levels of DAS. A score between 0 and 4, 0 and 3, 0-7 is considered normal DAS, respectively. A score between 5 and 6, 4 and 5, 8 and 9 is considered mild DAS, respectively. A score between 7 and 10, 6 and 7, 10-12 is considered moderate DAS, respectively. A score between 11 and 13, 8 and 9, 13-16 is considered severe DAS, respectively. A score above 13, 9, 16 is considered extremely severe D\&A, respectively.
Measured: 4 days after intervention
Pain severity
Pain will be assessed using pain numeric scale from 0-10 as the following. 0 no pain at all, 1-3 mild, 4-6 moderate, 7-10 sever
Measured: 4 days after intervention
Length of stay at the hospital
This will be abstracted from medical records after discharge and will be reported in days
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study startJun 2022 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Depression, Anxiety, Stress and PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention group, listened to holy Quran recitation for 10 minutes twice a day 4 hours a part (10 am and 2 pm) for 2 consecutive days (usually the 2nd and the 3rd day post-operative) after extubation and gaining alertness. We have chosen Surah Al-Rehman because it is considered as the most rhythmic surah of the Quran and the recitation of Qari Abdul Basit is very soothing and effective as he has recited from the deep of the heart. The listing was by a disposable head phones for an I pad for each hospital.
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Science Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghadeer Abd-Al-Qader Al-Dweik, Applied Science Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419544
- Sponsor's protocol ID
- AppliedSPU
- Status last verified
- Jun 2022
- First submitted
- 5 Jun 2022
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Holy Quran Recital on Depression, Anxiety, and Stress Post CABG: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05419544
- Acronym / sponsor ID
- AppliedSPU
- Keywords
- Holy Quran Recital, Depression, Anxiety, Stress, Pain, Length of stay, Open heart surgery, Coronary artery bypass graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Applied Science Private UniversityUniversity, hospital or other
- Study start
- Jun 2022 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 15 Jun 2022 (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.
Coronary artery bypass graft (CABG) is one of the most common surgical treatments for coronary artery disease. CABG has many beneficial outcomes for patients. However, there are diverse factors that hinder these positive outcomes. Depression, anxiety, and stress (DAS) are considered as important factors that hinder these outcomes.
Depression is very common post CABG. Despite that high levels of depression, more than half of patients undergoing CBAG are not screened or treated well for depression. Depression has negative outcomes for patients undergoing CABG. Similarly, patients undergoing CABG complain from high levels of anxiety and stress in the pre and even in the post-operative period.Anxiety and stress might be manifested as impaired functional status, chest pain, and shortness of breath.· Furthermore, increased anxiety and stress is correlated with poorer quality of life and worse long-term psychological outcomes.It has been shown that the speed of recovery from acute cardiac events depends more on psychological factors rather than physiological ones. Therefore, it is imperative to have an appropriate management for these negative emotions to improve the outcomes of this major operation.
Treatment options for these emotions include pharmacological and non-pharmacological.
Listening to the holy Quran recital is one of the non-pharmacological treatment methods that were integrated to improve Coronary Heart Diseases Patient's DAS symptoms.
Previous studies showed that listening to the holy Quran recital was effective in reducing ADS symptoms among this population and other populations including hemodialysis, pregnant women, and smokers. However, this effect has not been checked for patients undergoing CABG.
Therefore, the purpose of this randomized control trial (RCT) is to check the effect of Holy Quran recital on ADS among patients undergoing CABG surgery
Detailed description
Intervention: The intervention group, listened to holy Quran recitation for 10 minutes twice a day 4 hours a part (10 am and 2 pm) for 2 consecutive days (usually the 2nd and the 3rd day post-operative) after extubation and gaining alertness. We have chosen Surah Al-Rehman because it is considered as the most rhythmic surah of the Quran and the recitation of Qari Abdul Basit is very soothing and effective as he has recited from the deep of the heart. The listing will be by a disposable head phones for an I pad for each hospital. The control group received usual care by their nurses.
Measurement of variables: Sociodemographic and clinical characteristics will be measured either by patient interview (age, gender, pain level, marital status, educational level, smoking status, and working status) or by medical records review (history of hypertension, history of diabetes mellites, history of acute myocardial infarction, left ventricular ejection fraction, and body mass index, and length of stay at the hospital). Depression, anxiety and Stress will be measured using the Depression Anxiety Stress Scale (DASS21). DASS 21 is a set of self-reported items used to measure the intensity of DAS over the week prior to administration. DASS21 is the short version of the basic 42-item questionnaire DAS S-42, developed by Lovibond and Lovibond. It consists of three seven-item scales (a total of 21 items): depression scale (DS), anxiety scale (AS), and stress scale (SS). Items are measured through a four point Likert scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Items in each scale are summed whereby higher scores indicate higher levels of DAS. A score between 0 and 4, 0 and 3, 0-7 are considered normal DAS, respectively. A score between 5 and 6, 4 and 4, 8 and 9 are considered mild DAS, respectively. A score between 7 and 10, 6 and 7, 10 and 12 are considered moderate DAS, respectively. A score between 11 and 13, 8 and 9, 13 and 16 are considered severe DAS, respectively. A score above 13, 9, 19 are considered extremely severe DAS, respectively. The reliability of DASS21 was measured using Cronbach's alpha and was reported to be good; it was 0.91 for the depression subscale, and 0.80 for the anxiety subscale. The reliability of the Arabic version of DASS21 was measured using Cronbach's alpha coefficients and was found to be 0.76 for depression, 0.75 for anxiety.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention group, listened to holy Quran recitation for 10 minutes twice a day 4 hours a part (10 am and 2 pm) for 2 consecutive days (usually the 2nd and the 3rd day post-operative) after extubation and gaining alertness. We have chosen Surah Al-Rehman because it is considered as the most rhythmic surah of the Quran and the recitation of Qari Abdul Basit is very soothing and effective as he has recited from the deep of the heart. The listing was by a disposable head phones for an I pad for each hospital.
| Arm | Type | Receives |
|---|---|---|
| The intervention group/ Holy Quran Recital | Experimental | Behavioral: Holy Quran Recital effectThe intervention group, listened to holy Quran recitation for 10 minutes twice a day 4 hours a part (10 am and 2 pm) for 2 consecutive days (usually the 2nd and the 3rd day post-operative) after extubation and gaining alertness. We have chosen Surah Al-Rehman because it is considered as the most rhythmic surah of the Quran and the recitation of Qari Abdul Basit is very soothing and effective as he has recited from the deep of the heart. The listing was by a disposable head phones for an I pad for each hospital. |
| The control group/ Usual care by the nurse | No intervention | –The control group received usual care by their nurses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 and above,
- Elective CABG surgery,
- Able to communicate with the researcher during the intervention and the interview,
- Able to read and write Arabic,
- Welling to participate in the study and signed an informed consent,
Key exclusion criteria (0 listed)
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 Recital effectThe intervention group, listened to holy Quran recitation for 10 minutes twice a day 4 hours a part (10 am and 2 pm) for 2 consecutive days (usually the 2nd and the 3rd day post-operative) after extubation and gaining alertness. We have chosen Surah Al-Rehman because it is considered as the most rhythmic surah of the Quran and the recitation of Qari Abdul Basit is very soothing and effective as he has recited from the deep of the heart. The listing was by a disposable head phones for an I pad for each hospital. The control group received usual care by their nurses. | Behavioural | The intervention group/ Holy Quran Recital |
Primary outcome
Depression, anxiety and Stress level
Time frame: 4 days after intervention
Depression, Anxiety, and Stress will be measured by The Depression, Anxiety, and Stress Scale (DASS21). DASS 21 is a set of self-reported items used to measure the intensity of depression, anxiety and stress. It consists of three seven-item scales (a total of 21 items): depression scale (DS), anxiety scale (AS), and stress scale (SS). Items are measured through a four point Likert scale from 0 (did not apply to me at all) to 3 (applied to me very much, or most of the time). Items in each scale are summed, whereby higher scores indicate higher levels of DAS. A score between 0 and 4, 0 and 3, 0-7 is considered normal DAS, respectively. A score between 5 and 6, 4 and 5, 8 and 9 is considered mild DAS, respectively. A score between 7 and 10, 6 and 7, 10-12 is considered moderate DAS, respectively. A score between 11 and 13, 8 and 9, 13-16 is considered severe DAS, respectively. A score above 13, 9, 16 is considered extremely severe D\&A, respectively.
Pain severity
Time frame: 4 days after intervention
Pain will be assessed using pain numeric scale from 0-10 as the following. 0 no pain at all, 1-3 mild, 4-6 moderate, 7-10 sever
Length of stay at the hospital
Time frame: through study completion, an average of 3 months
This will be abstracted from medical records after discharge and will be reported in days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Individual participant dataSharing planned: Undecided. Data will be shared upon request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Holy Quran Recital effect in people with Patient Depression, Anxiety, Stress and Pain, run by Applied Science Private University at 2 sites in Jordan.
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 7 inclusion and 0 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 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, anxiety and Stress level (time frame: 4 days after intervention). The study lists 3 primary outcomes in all. 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 15 Jun 2022.