To determine the effectiveness of Melatonin on prevention of delirium in patients admitted to intensive care units.
Design
Clinical trials with control group, with parallel groups, triple blinded, randomized on 70 patients in each group
Settings and conduct
The study is carried out at the of Besat Hospital in Hamedan.
To ensure blinding, the allocation sequence will be created by a different investigator than the one enrolling participants. A third investigator will be responsible for patient follow-up and assessments. Patients will not know what group they are in. Patients, researchers, and data collectors will not be aware of patient grouping. The two intervention and control groups will not be specified for the statistician. The medication regimen of the intervention and control group patients has different pills, the intervention group patients will not know which pill is melatonin.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Ages 17 to 70 years old;
Having the power of communication;
Hospitalized for at least seven days in ICU ward;
RASS score equal to or greater than -3 ;
Non-inclusion criteria:
history of psychiatric disorders such as psychosis and
mental retardation
Intervention groups
Intervention group: receiving 7 days of 3 mg sublingual melatonin tablets at 9 pm + receiving standard treatment in the intensive care unit
Control group: receiving standard treatment in the intensive care unit
Main outcome variables
Delirium incidence; number of admission days
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100816004578N8
Registration date:2020-05-12, 1399/02/23
Registration timing:retrospective
Last update:2020-05-12, 1399/02/23
Update count:0
Registration date
2020-05-12, 1399/02/23
Registrant information
Name
Farshid Rahimibashar
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 811264002151
Email address
f.rahimi@umsh.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-15, 1398/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Melatonin on the incidence of delirium in patients admitted to the intensive care unit: A randomized controlled clinical trial
Public title
Effect of Melatonin on prevention of delirium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 17 to 70 years
Having the power of communication
RASS score equal to or greater than -3
Hospitalized for at least seven days in ICU ward
Exclusion criteria:
Vision and hearing problems
History of mental disorders such as psychosis and mental retardation
History of antipsychotic medication use
To ensure blinding, the allocation sequence will be created by a different investigator than the one enrolling participants. A third investigator will be responsible for patient follow-up and assessments. Patients will not know what group they are in. Patients, researchers, and data collectors will not be aware of patient grouping. The two intervention and control groups will not be specified for the statistician.
The medication regimen of the intervention and control groups has different pills, the intervention group patients will not know which pill is Melatonin.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Approval date
2019-12-07, 1398/09/16
Ethics committee reference number
IR.UMSHA.REC.1398.723
Health conditions studied
1
Description of health condition studied
Delirium
ICD-10 code
F05
ICD-10 code description
Delirium due to known physiological condition
Primary outcomes
1
Description
Delirium incidence
Timepoint
Daily
Method of measurement
Confusion Assessment Method for the ICU (CAM-ICU); Intensive Care Delirium Screening Checklist (ICDSC)
Secondary outcomes
1
Description
Number of admission days
Timepoint
after discharge from hospital
Method of measurement
patient's records
Intervention groups
1
Description
Intervention group: Melatonin 3 mg tablet, orally at 9 p.m, every night for one week or till discharge from ICU + Receiving standard treatment of the intensive care unit
Category
Prevention
2
Description
Control group: Receiving standard treatment of the intensive care unit
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Farshid Rahimi-Bashar
Street address
General ICU, Besat Hospital, Shahid Motahhari boulevar, Resalat square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0047
Email
f.rahimi@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamadan University of Medical Science, Shahid Fahmide boulevard, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3838 0572
Email
f.rahimi@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi-Bashar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
General ICU, Besat Hospital, Shahid Motahhari boulevar, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0047
Email
fr_rahimibashar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi-Bashar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
General ICU, Besat Hospital, Shahid Motahhari boulevar, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65148454411
Phone
+98 81 3264 0047
Email
fr_rahimibashar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Farshid Rahimi-Bashar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
General ICU, Besat Hospital, Shahid Motahhari boulevar, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65148454411
Phone
+98 81 3264 0047
Email
fr_rahimibashar@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD