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The Effect of Listening to Holy Quran Recital on Depression, Anxiety and Stress Post CABG

Primary Purpose

Patient Depression, Anxiety, Stress and Pain

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Holy Quran Recital effect
Sponsored by
Applied Science Private University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Patient Depression, Anxiety, Stress and Pain focused on measuring Holy Quran Recital, Depression, Anxiety, Stress, Pain, Length of stay, Open heart surgery, Coronary artery bypass graft

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Sites / Locations

  • AppliedSPURecruiting
  • Ghadeer Al Dweik

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

The intervention group/ Holy Quran Recital

The control group/ Usual care by the nurse

Arm 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.

The control group received usual care by their nurses.

Outcomes

Primary Outcome Measures

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.
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
Length of stay at the hospital
This will be abstracted from medical records after discharge and will be reported in days

Secondary Outcome Measures

Full Information

First Posted
June 5, 2022
Last Updated
June 10, 2022
Sponsor
Applied Science Private University
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1. Study Identification

Unique Protocol Identification Number
NCT05419544
Brief Title
The Effect of Listening to Holy Quran Recital on Depression, Anxiety and Stress Post CABG
Official Title
The Effect of Listening to Holy Quran Recital on Depression, Anxiety, and Stress Post CABG: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Applied Science Private University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Depression, Anxiety, Stress and Pain
Keywords
Holy Quran Recital, Depression, Anxiety, Stress, Pain, Length of stay, Open heart surgery, Coronary artery bypass graft

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
The intervention group/ Holy Quran Recital
Arm Type
Experimental
Arm 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 Title
The control group/ Usual care by the nurse
Arm Type
No Intervention
Arm Description
The control group received usual care by their nurses.
Intervention Type
Behavioral
Intervention Name(s)
Holy Quran Recital effect
Intervention 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. The control group received usual care by their nurses.
Primary Outcome Measure Information:
Title
Depression, anxiety and Stress level
Description
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.
Time Frame
4 days after intervention
Title
Pain severity
Description
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
Time Frame
4 days after intervention
Title
Length of stay at the hospital
Description
This will be abstracted from medical records after discharge and will be reported in days
Time Frame
through study completion, an average of 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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
Facility Information:
Facility Name
AppliedSPU
City
Amman
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghadeer A Dweik
Phone
+962795087119
Email
ghadeerdweik@yahoo.com
Facility Name
Ghadeer Al Dweik
City
Multiple Locations
Country
Jordan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ghadeer A Dweik, PhD
Phone
+962795087119
Email
ghadeerdweik@yahoo.com
First Name & Middle Initial & Last Name & Degree
Ghadeer A Al Dweik, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Data will be shared upon request

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The Effect of Listening to Holy Quran Recital on Depression, Anxiety and Stress Post CABG

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