Investigating the effect of magnesium supplementation on anxiety and depression and sleep quality
Design
This research will be performed as double-blind clinical trial on CABG candidate patients hospitalized in Jamaran hospital. Patients will be selected by available sampling method and will be randomly assigned to both intervention and control groups.
Settings and conduct
This research will be performed by double-blind clinical trial on CABG candidate patients admitted to Jamaran Hospital in Tehran.
Participants/Inclusion and exclusion criteria
The criteria for admission were: CABG candidate patients admitted to Jamaran Hospital.Younger than 70 years-without having atrial fibrillation Lack of developing nausea-vomiting-without having to kidney failure and liver-no history of transient ischemic attack and ischemic stroke within the last month
Exclusion criteria were as follows: emergency surgery, supplement sensitivity, history of sleep disorders, anxiety, and depression.
Intervention groups
Intervention group: Magnesium supplementation.
Control group (Placebo): Starch
Main outcome variables
sleep quality ; anxiety and depression
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200523047556N1
Registration date:2020-07-04, 1399/04/14
Registration timing:registered_while_recruiting
Last update:2020-07-04, 1399/04/14
Update count:0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
Sara Saba
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4452 4511
Email address
samansayeh8594@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Magnesium supplementation on patients' depression and anxiety and sleep quality after cardiac surgery
Public title
Magnesium in depression and anxiety and sleep quality
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age less than 70 years
Candidate for coronary artery bypass graft surgery
No atrial fibrillation (normal sinus)
No nausea and vomiting
No liver and kidney failure
No history of stroke or cerebral ischemic attack in one month
Exclusion criteria:
No willingness to participate in the study
Emergency surgery
Acute renal failure during the study
Respiratory after surgery and the need for re-intubation inside the chip
Chronic diarrhea
Sensitivity to supplements
History of sleep disorders, anxiety and depression
Age
To 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to the intervention and control groups using block randomization. Arrangement of the randomization process: 1) Determining the volume of each block (quadruple blocks) 2) Preparing the list of the blocks and assigning a number (between 1 and 6 ) to each of them 3)Choosing random numbers between 1 and 6 4) Defining the treatment assignment list
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the statistician and patients do not know which group has received magnesium and which group has received placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah Educational and Medical Center
Street address
No.3,24 Ave, Tehransar Blvd.,Tehran
City
Tehran
Province
Tehran
Postal code
1388648736
Approval date
2020-01-04, 1398/10/14
Ethics committee reference number
IR.BMSU.BAQ.REC.1398.029
Health conditions studied
1
Description of health condition studied
Other functional disturbances following cardiac surgery
ICD-10 code
I97.1
ICD-10 code description
I97.1
Primary outcomes
1
Description
Sleep quality
Timepoint
Measuring the quality of sleep before prescribing magnesium supplements the day after surgery and the day of discharge from the hospital.
Method of measurement
Pittsburgh questionnaire
2
Description
Anxiety
Timepoint
Measuring the anxiety and before prescribing magnesium supplements the day after surgery and the day of discharge from the hospital.
Method of measurement
Anxiety Questionnaire
3
Description
Depreesion
Timepoint
Measuring depression before prescribing magnesium supplements the day after surgery and the day of discharge from the hospital.
Method of measurement
Depreesion Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Intervention group: Receiving 250 mg of magnesium oxide supplement tablets per day for 5 days from the time of hospitalization to the day of discharge. Magnesium tablets prepared by Wardavard Pharmaceutical Co.
Category
Prevention
2
Description
Control group: Starch drug preparation prepared by Verdavard Pharmaceutical Company: (Ovisil 100) for 5 days daily, two from the first day of hospitalization to the day of discharge