Protocol summary

Study aim
study for The effect of oral melatonin on sleep quality of hospitalized patients in the intensive care unit
Design
randomized clinical trial with control and factorial group
Settings and conduct
for the Patients addmited in icu(gonabad, mashhad & sarakhs) complete the demographic information including age, weight, BMI, occupation, education level, Apache 2 form and numerical/face scale of pain.Patients will be divided into control and intervention groups. For the intervention group at the end of the second night of hospitalization, after measuring GCS,RCSQ Questionnaire and numerical/face scale of pain were completed.Then, from the third night of hospitalization for 4 nights at 9 pm, 3 mg of melatonin tablets were given to the patient. the pain score and RCSQ questionnaire were completed at the end of the sixth night for both groups. At the end, patients' sleep quality in both groups was assessed before and after the intervention.
Participants/Inclusion and exclusion criteria
Patients admitted to Gonabad, mashhad and sarakhs Hospitals and they have GCS score ≥10 and stable hemodynamic.they haven't been organ failures such as gastrointestinal and severe heart failure, liver/renal insufficiency, history of convulsions, psychiatric or neurological disease, sleep apnea, deafness, blindness,chronic insomnia, narcolepsy and alcohol/drug use(addiction).patients with out severe pain and narcotic/sedation drug order
Intervention groups
For the patients after measuring GCS,Richard Campbell Sleep Quality Questionnaire and numerical/face scale of pain were completed.Then,from the third night of hospitalization for 4 nights at 9pm, 3 mg of melatonin tablets were given to the intervention group. the pain score and RCSQ questionnaire were completed at the end of the sixth night for both control and intervention groups.
Main outcome variables
pain score, sleep quality, GCS

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191105045342N1
Registration date: 2020-01-20, 1398/10/30
Registration timing: registered_while_recruiting

Last update: 2020-01-20, 1398/10/30
Update count: 0
Registration date
2020-01-20, 1398/10/30
Registrant information
Name
Malihe Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3452 6917
Email address
heydarim10@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-16, 1398/09/25
Expected recruitment end date
2020-04-19, 1399/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of oral melatonin on sleep quality of hospitalized patients in the intensive care unit
Public title
The effect of melatonin on sleep quality of patients in the intensive care unit
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Glasgow Coma Scale (GCS) score ≥10 patients with stable hemodynamic patients with out alcohol consumption ≥50 units per week or drug use(addiction) / narcotic or sedation drug order in icu haven't been used of drugs that might alter melatonin secretion and decrease plasma levels of melatonin, such as benzodiazepines, NSAIDs, corticosteroids, beta-blockers, haloperidol and amiodarone / sedation with propofol, morphine, alfentanil and dexmedetomidine has been discontinued for a minimum of 36 hours (48 hours for lorazepam and midazolam) before enter to study Apache II score < 35 and Estimated mortality < 75% patients with out severe pain level (pain score > 7 on the numerical scale of pain) for one hour before the prescribe of melatonin patients with out history of convulsions, psychiatric or neurological disease, deafness or blindness and the lack of any kind of sleep disorder such as sleep apnea, narcolepsy, chronic insomnia, restless legs syndrome (RLS) patients with out liver insufficiency and renal insufficiency (requires dialysis) patients with out severe heart failure (the New York Heart Association classification III/IV) patients with out intestinal obstruction, ileus or other conditions likely to affect the enteral absorption of melatonin Do not be pregnant or breast-feeding women more than 24 hours have passed from general anesthesia or hospitalization age ≥18 years old and ≤ 60 years old
Exclusion criteria:
The incidence of gastrointestinal failure that prevents the absorption of melatonin, including obstruction and ileus The incidence of renal insufficiency (requires dialysis) The incidence of any kind of sleep disorder such as sleep apnea, narcolepsy over night sleep Pain scores above 7 on the numerical scale of pain during the intervention Lack of willingness to cooperate in the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Gonabad University of Medical Sciences
Street address
Bohlool hospital, Sadi Ave., Parastar Blvd., Gonabad Town
City
Gonabad
Province
Razavi Khorasan
Postal code
7887906432
Approval date
2019-12-31, 1398/10/10
Ethics committee reference number
IR.GMU.REC.1398.141

Health conditions studied

1

Description of health condition studied
Addmited ptients in the intensive care unit
ICD-10 code
G47
ICD-10 code description
Sleep disorders

Primary outcomes

1

Description
Richards Campbell sleep questionaire score
Timepoint
before intervention, sixth night after addmited ( fourth night after intervention)
Method of measurement
The person on the line specified in each of the 5 questions (Richards Campbell sleep questionaire score ) gives the best description of his or her sleep last night. The score for each question is between 0 and 100, which in total score is divided by 5 and between 0 and 100 points of sleep quality.

2

Description
Glasgow coma score
Timepoint
before intervention and during the study
Method of measurement
According to the Glasgow coma score table (3-15) . The motor score is 6 points, the verbal score 5 points, and the visual score 4 points.

3

Description
pain scale (numerical/face)
Timepoint
before intervention, during the study and sixth night after addmited ( fourth night after intervention)
Method of measurement
The Visual Analogue Scale is a 10 cm vertical linear pain that is numbered from 0 to 10, or points to a symbolic face. Zero means \"completely pain free" and 10 means "maximum pain intensity". On a numerical scale, pain ratings are usually described as 0 -3 as mild pain, 4 to 6 as moderate pain, and 7 to 10 as severe pain.

4

Description
Apache 2 score
Timepoint
The first 24 hours hospitalization
Method of measurement
The Apache 2 scale consists of three components: 1 - Acute physiology score ( APS )2 - Age adjustment3 - Chronic health evaluation (CHE). Finally, we summarize the scores obtained from all three components. Patients may receive 0 to 71 points. According to the standard table, if the patient's score is between 0, 15, 16 to 19, 20 to 30 and more than 30 points, the risk of death is 10, 15, 35 and > 75%, respectively.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:Tab melatonin, 3 mg, once a day at 9 pm, for 4 night, oral
Category
Treatment - Drugs

2

Description
Control group: with out intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Allameh Bohlool Gonabadi hospital
Full name of responsible person
Malihe Heydari
Street address
Bohlool hospital, Sadi Ave., Parastar Blvd.,Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
7887906432
Phone
+98 51 5723 6833
Email
info@gmu.ac.ir
Web page address
http://bohlool.gmu.ac.ir/

2

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Malihe Heydari
Street address
Imam Reza hospital, Imam Reza Square., Ibn-e Sina Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Fax
+98 51 3859 1057
Email
emamreza@mums.ac.ir
Web page address
http://emamreza.mums.ac.ir/index.php

3

Recruitment center
Name of recruitment center
Loghman Hakim hospital
Full name of responsible person
Malihe Heydari
Street address
Loghman Hakim hospital, Valiasr Blvd., Sarakhs
City
Sarakhs
Province
Razavi Khorasan
Postal code
9381737448
Phone
+98 51 3452 2229
Fax
+98 51 3453 8463
Email
heydarim10@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Shahla Khosravan
Street address
Bohlool hospital, Sadi Ave., Parastar Blvd., Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
7887906432
Phone
+98 51 5722 3028
Fax
+98 51 5722 0578
Email
khosravan@gmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gonabad University of Medical Sciences
Proportion provided by this source
70
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
Gonabad University of Medical Sciences
Full name of responsible person
Malihe Heydari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 106, keshavarzi Ave, Sarallah Blvd, Sarakhs Town
City
Sarakhs
Province
Razavi Khorasan
Postal code
9381737448
Phone
+98 51 3452 6917
Fax
Email
heydarim10@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Mohsen Saheban Maleki
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Bohlool hospital, Sadi Ave., Parastar Blve., Gonabad
City
Gonabad
Province
Razavi Khorasan
Postal code
7887906432
Phone
+98 51 5723 6833
Email
dr.saheban@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Gonabad University of Medical Sciences
Full name of responsible person
Malihe Heydari
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 106, keshavarzi Ave, Sarallah Blvd, Sarakhs Town
City
Sarakhs
Province
Razavi Khorasan
Postal code
9381737448
Phone
+98 51 3452 6917
Fax
Email
heydarim10@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is shared after unidentifiable people
When the data will become available and for how long
Start accessing 6 months after publishing results
To whom data/document is available
For researchers working only in academic and scientific institutions
Under which criteria data/document could be used
only major consequence
From where data/document is obtainable
Send request to phone number : 0098 51 34526917 and email : heydarim10@gmail.com
What processes are involved for a request to access data/document
Email request in writing
Comments
Loading...