Determining the effect of melatonin on preoperative anxiety in hysterectomy surgery
Design
A double-blinded, randomized clinical trial, phase 3 with parallel groups, that includes a control group, design of 80 patients.
Settings and conduct
This clinical trial will be done in Alzahra Hospital in Rasht, on patients candidate for hysterectomy. 80 patients randomly and with quadruple block method will be divided in two groups of receiving lorazepam + melatonin and lorazepam + sugar water. After receiving the drug, patients will be transferred to the recovery room and monitored to control Blood pressure and heart rate. The basis for comparing these two groups is Visual Aualogue Scale. We will measure three times in this study: Before Prescribing the drug, when patients enter the operating room and before the anesthetic induction. Finally, the data will be compared in the two groups. In this study, patients, the responsible anesthesiologist, and the information collector are BLIND.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate for elective abdominal hysterectomy, Aged 30-65. Exclusion criteria: Major surgery in the past three years.Chronic health problems. Mood disorders (anxiety). Addiction.
Intervention groups
Intervention group: Lorazepam( manufacturer company: Abidi) 1 milligram given at the preoperative night+ 6 milligrams of melatonin( 2 pills of 3 milligrams, manufacturer company: Aristo) 90 minutes before operation dissolved in 20 milliliters of water + 2 sugar loaves.Control group: Lorazepam 1 milligram in the preoperative night( manufacturer company: Abidi) + 90 minutes before operation 20 milliliters of water + 2 sugar loaves.
based on the hospital routine, all patients candidate for hysterectomy will be given lorazepam 1miligramms, preoperative night, (as a sedative).
Main outcome variables
Preoperative anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100707004345N6
Registration date:2019-04-11, 1398/01/22
Registration timing:prospective
Last update:2019-04-11, 1398/01/22
Update count:0
Registration date
2019-04-11, 1398/01/22
Registrant information
Name
Ali Mirmansouri
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 9064
Email address
a_mirmansoori@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-05, 1398/02/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of melatonin on reducing preoperative anxiety in abdominal hysterectomy; a double blinded clinical trial study
Public title
The effect of melatonin on anxiety before hysterectomy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for elective abdominal hysterectomy
Aged 30-65
Exclusion criteria:
Major surgery for the past three years
Chronic health problems like diabetes, cardiovascular disease
Mood disorders (anxiety) that are under medication
Addiction
Malignant problems that cause hysterectomy
Emergency hysterectomy
Age
From 30 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
To produce random sequences in this clinical trial, we will use this site: http://www.graphpad.com/quickcalcs/index.cfm. A nurse who is not in the study, 90 minutes before surgery, will randomly divide patients into two groups by quadruple block method that includes: lorazepam + melatonin( dissolved in 20 milliliters sugar water) group and lorazepam+ sugar water group.
Blinding (investigator's opinion)
Double blinded
Blinding description
A nurse who is not in the study randomly will divide patients into two groups and 90 minutes before surgery, for the intervention group, she will dissolve two melatonin pills in 20 milliliters of water. 2 sugar loaves will be added to it for not determining the taste. In the Control group, the same amount of sugar water is prescribed. After receiving the drug, the patient will be transferred to the recovery room and will be monitored to control blood pressure and heart rate. In this study, patients, the responsible anesthesiologist, and the information collector are BLIND.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Guilan University Of Medical Sciences
Street address
Vice Chancellor for research, Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Approval date
2019-03-16, 1397/12/25
Ethics committee reference number
IR.GUMS.REC.1397.528
Health conditions studied
1
Description of health condition studied
Anxiety before abdominal hysterectomy surgery
ICD-10 code
F43
ICD-10 code description
Reaction to severe stress and adjustment disorders
Primary outcomes
1
Description
Patient's anxiety before surgery
Timepoint
Before prescribing the drug, when patients enter the operating room and before the anesthetic induction
Method of measurement
Visual Aualogue scale
Secondary outcomes
1
Description
Blood pressure
Timepoint
Before prescribing the drug, when patients enter the operating room and before the anesthetic induction
Method of measurement
Manometer
2
Description
Heart rate
Timepoint
Before prescribing the drug, when patients enter the operating room and before the anesthetic induction
Method of measurement
Monitoring
Intervention groups
1
Description
Intervention group: The group receiving lorazepam + Melatonin: Dosage of Melatonin for patients will be 6 milligrams based on previous studies. (3 milligrams tablets are available on the market, so two tablets are considered).(manufacturing Company: Aristo ).As the routine of this hospital is to prescribe 1miligramm lorazepam( manufacturing Company: Abidi)preoperative night for all patients candidate for hysterectomy, so both groups will receive this amount of lorazepam. (This treatment alone did not control anxiety in patients.)90 minutes Prior to surgery, a nurse who is not in the study will dissolve melatonin pills in 20 milliliters of water and will add 2 sugar loaves in order to not determine its taste.
Category
Prevention
2
Description
Control group: The group receiving lorazepam + sugar water: preoperative night 1miligramm lorazepam( manufacturing Company: Abidi) will be given to patients.90 minutes prior to surgery,2 sugar loaves will be dissolved in 20 milliliters of water and it will be given to the patient by a nurse who is not in the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr Ali Mirmansouri
Street address
Opposite Shahid Azodi Stadium,Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9324
Fax
+98 13 3336 9024
Email
azzahra@gums.ac.ir
Web page address
http://www.gums.ac.ir/azzahra
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Doctor Shadman Nemati
Street address
Vice Chancellor for research of Guilan,Shahid Siadati Avenue, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144666949
Phone
+98 13 3333 5821
Fax
+98 13 3333 6395
Email
drshadmannemati_ent@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Ali Mirmansouri
Position
Associate Professor of Cardiac Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Heshmat Hospital, at the beginning of bayani street, Mosalla Square
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 1666 9064
Fax
+98 13 1666 8718
Email
a_mirmansoori@gums.ac.ir
Web page address
http://www.gums.ac.ir/arc
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Ali Mirmansouri
Position
Associate Professor of Cardiac Anesthesiology
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Heshmat Hospital, at the beginning of bayani street, Mosalla Square
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 1666 9064
Fax
+98 13 1666 8718
Email
a_mirmansoori@gums.ac.ir
Web page address
http://www.gums.ac.ir/arc
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohadese Ahmadi
Position
Research Expert/(MSc) English
Latest degree
Master
Other areas of specialty/work
Research Expert
Street address
Anestesiology Reseaech Center, Alzahra Hospital, Namjoo Street
City
Rasht
Province
Guilan
Postal code
4144654839
Phone
+98 13 3336 9328
Email
p.ahmadi2311@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available