Protocol summary
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Study aim
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Investigate the effect of Holy Quran voice on prevention of delirium after cardiac surgery.
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Design
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This study has intervention and control groups and is blind on one side. The sample size predicted for this study is 108 people and will be randomized into blocks
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Settings and conduct
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TIn this randomized clinical trial, 108 patients with cardiac surgery referred to Golestan Hospital in Ahvaz in 2018 will be selected using the consecutive sampling and randomly assigned into groups of experimental and control. In the intervention group, the voice of Quran plays twice daily for 10 minutes each time. Patients are evaluated twice daily for Delirium. In the control group, routine care will be performed. Blind study will be done using a research fellow. So that the researcher who has the task of evaluating the outcome is not informed about the allocation of patients.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria: Age of 18 to above; having the orientation to time, place, person; Being Muslim; Lack of mental disorders; Talking in Farsi
Exclusion criteria: Alcoholism or substance abuse; having a hearing problem; not having the consent to enter the study
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Intervention groups
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In the intervention group, the voice of the Quran plays twice daily for 10 minutes each time. Patients are evaluated twice daily for Delirium. In the control group, routine care is performed.
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Main outcome variables
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Delirium
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20171222037990N1
Registration date:
2018-11-27, 1397/09/06
Registration timing:
registered_while_recruiting
Last update:
2019-07-09, 1398/04/18
Update count:
1
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Registration date
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2018-11-27, 1397/09/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-22, 1397/09/01
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Expected recruitment end date
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2019-02-04, 1397/11/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Investigating the effect of Holy Quran Voice on delirium prevention after cardiac surgery
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Public title
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The effect of Holy Quran Voice on Prevention of Delirium
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age of 18 to above
Having orientation to time, place, person
Being Muslim
Lack of mental disorders
Talking in Farsi
Exclusion criteria:
Alcoholism or substance abuse
Having a hearing problem
Not having the consent to enter the study
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Age
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From 18 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
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Sample size
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Target sample size:
108
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, patients will be randomly assigned to the study. By assigning the letter A to the intervention group and the letter B to the control group, the ABBA ،BABA ،ABAB ،BBAA ،AABB ،BAAB are written in separate sheets and inserted into the container. Then, we randomly take one of these sheets out of the container and write the written compound on it and replace that sheet inside the container. Since the sample size in this study is 108 patients, this procedure is repeated twenty-seven times, and each time the composition is written on each sheet in the sequence of the compound written in the previous sheet is noted. Then each of the letters of a number from one to 108 is assigned sequences written in sequence, and each of the letters is placed inside a packet and written on the envelope of that letter. Each time the patient is selected, one of these packets is opened in the order of the number written on the envelope, and it is determined that the patient should be placed in the intervention or control group.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The colleague of the researcher will be responsible for assigning patients to the control and intervention groups, and the researcher who has the task of evaluating the outcome will not know how to allocate patients.
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-10-29, 1397/08/07
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Ethics committee reference number
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IR.SHAHED.REC.1397.056
Health conditions studied
1
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Description of health condition studied
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Delirium
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ICD-10 code
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F05
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ICD-10 code description
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Delirium due to known physiological condition
Primary outcomes
1
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Description
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Delirium
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Timepoint
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In this study, delirium is evaluated twice daily at 10 to 11 and 17 to 18 .
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Method of measurement
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The Confusion Assessment Method for the ICU (CAM-ICU)
Secondary outcomes
1
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Description
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Sleep score
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Timepoint
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The researcher will assess the quality and quantity once a day at 12 noon.
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Method of measurement
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Richard Campbell questionnaire.
2
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Description
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Anxiety Score
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Timepoint
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The level of anxiety will be evaluated on the first day of admission and on the day of discharge.
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Method of measurement
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Hospital Anxiety and Depression Scale (HADS)
Intervention groups
1
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Description
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"Intervention group": After the extubation of the patient, the voice of the Quran will be broadcast twice a day by the headphones for ten minutes.
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Category
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Prevention
2
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Description
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Control group: routine care is provided in this group.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahed University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available