NCT05419544

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 5, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

June 5, 2022

Last Update Submit

June 10, 2022

Conditions

Keywords

Holy Quran RecitalDepressionAnxietyStressPainLength of stayOpen heart surgeryCoronary artery bypass graft

Outcome Measures

Primary Outcomes (3)

  • 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.

    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

    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

    through study completion, an average of 3 months

Study Arms (2)

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.

Behavioral: Holy Quran Recital effect

The control group/ Usual care by the nurse

NO INTERVENTION

The control group received usual care by their nurses.

Interventions

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.

The intervention group/ Holy Quran Recital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AppliedSPU

Amman, Jordan

RECRUITING

Ghadeer Al Dweik

Multiple Locations, Jordan

NOT YET RECRUITING

MeSH Terms

Conditions

Anxiety DisordersPainDepression

Condition Hierarchy (Ancestors)

Mental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of nursing administration, Head of clinical nursing department

Study Record Dates

First Submitted

June 5, 2022

First Posted

June 15, 2022

Study Start

June 1, 2022

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

June 15, 2022

Record last verified: 2022-06

Locations