NCT06346990

Brief 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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable coronary-artery-disease

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2025

Completed
Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

12 months

First QC Date

March 29, 2024

Last Update Submit

April 4, 2024

Conditions

Keywords

Deliriumlength of stay

Outcome Measures

Primary Outcomes (1)

  • Delirium

    The effect of holy quran recital on the incidence of delirium

    Within one week after the operation

Secondary Outcomes (2)

  • Length of stay-ICU

    Within one week after the operation

  • Length of stay-hospital

    Within two week after the operation

Study Arms (2)

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.

Other: Holy Quran Recital

The control group

NO INTERVENTION

For the control group, routine post-operative care was done

Interventions

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

The intervention group/ Holy Quran Recital

Eligibility Criteria

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

You may qualify if:

  • years old and older;
  • undergone elective CABG surgery;
  • hemodynamically stable during interventions and interviews;
  • signed an informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseEmergence DeliriumDelirium

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Central Study Contacts

Mohannad E. AbuRuz, PhD

CONTACT

Mohannad E. AbuRuz, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Taking into consideration that this was a RCT, blinding the participants was not possible. However, data collectors and data analyzer were blinded. Directly after the intervention, each day at 3pm and 9 pm, the participants were evaluated for development of delirium by the Research assistant how do not know in which group was the participant allocated, and if the result was positive the intervention was discontinued.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Critical Care Nursing

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 4, 2024

Study Start

April 15, 2024

Primary Completion

April 14, 2025

Study Completion

May 15, 2025

Last Updated

April 5, 2024

Record last verified: 2024-04