1. Comparison the effect of Acetaminophen and Ibuprofen on emotions by using Electroencephalography signals.
2. The negative effects of painkillers on emotional states and people's empathy
Design
Non randomized clinical trial; Phase 1; 54 volunteers
Settings and conduct
This study performs in laboratory of Islamic Azad University of Central Tehran Branch. Three steps performs for all of subjects between three to seven days; thereby, the electroencephalography brain signals obtain without receiving any medication, with receiving acetaminophen and Ibuprofen during music listening. Each participant listen to a three-minute audio music track for each emotion. Before and after listening of music excerpts and electroencephalography recording, each of people fulfill the questionnaires regarding their emotions.
Participants/Inclusion and exclusion criteria
Inclusion criteria include:
1. People over 18 years old without neurological diseases
2. Right-handed people
Inclusion criteria include:
1. Patients participating in other clinical studies
2. Pregnant or lactating women
3. Sensitivity to any of the drug compounds
Intervention groups
The study will be performed on 54 volunteers without a history of any disease in three stages. Thus, in one stage of signal recording from individuals without receiving any medication and 3 to 7 days later, the person will receive 500 mg of acetaminophen tablets and the signal will be recorded again, in the other stage, the same people in a period of 3-7 take 400 mg of ibuprofen tablets daily. Brain signals are received in three states of joy, sadness and neutrality in the three mentioned stages. Our stimulus in this research is an audio music that creates a state of joy and sorrow in people.
Comparison the effects of Acetaminophen and Ibuprofen on emotions by recording electrical activity of the brain
Public title
Comparison the effects of Acetaminophen and Ibuprofen on emotions
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All participants should be right-handed
They have normal hearing sensitivity
No reported history of brain diseases like depression or alzheimer.
No head trauma, stroke or injury
Do not have history of alcohol and smoking (especially a few days before the signal is recorded)
Exclusion criteria:
Pregnancy
Breastfeeding
Preexisting neurological or psychological disorders
Severe liver failure based on Child-Pugh Score
Renal failure (Glomerular Filtration Rate (GFR) < 15 mL/min)
History of prior anti-psychotic or anti-epileptic use
Allergy to oral Acetaminophen and non-steroidal anti-inflammatory drug (NSAID)
History of smoking or alcohol abuse
Age
From 18 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
54
Actual sample size reached:
54
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Iran University of Medical Sciences
Street address
Iran University Of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-01-19, 1398/10/29
Ethics committee reference number
IR.IUMS.REC.1398.1085
Health conditions studied
1
Description of health condition studied
Healthy volunteers
ICD-10 code
R45.89
ICD-10 code description
Other symptoms and signs involving emotional state
Primary outcomes
1
Description
Emotional arousal score in questionnaire between 0-5.
Timepoint
Survey the emotional state immediately after the recording for checking the effect of painkiller.
Method of measurement
Asking participants after recording and score the music from 0-5. and observe and analyze brain signals in both happiness and sadness.
Secondary outcomes
empty
Intervention groups
1
Description
In the first stage, participants are given a brain signal for each emotional state (happiness-sadness-neutral) while listening to a three-minute music. Before and after listening to music, each person fills out a questionnaire according to their feelings. In the second stage, the signal is recorded by receiving acetaminophen (500) mg of Rouz Darou Pharmaceutical Company while listening to the mentioned music. Before and after listening to music, each person fills out the questionnaire according to their feelings. In the third stage, the signal is recorded by receiving ibuprofen (400 mg) from Dana Pharmaceutical Company while listening to the music. . Before and after listening to music, each person fills out a questionnaire according to their feelings.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr.Maryam Farasatinasab
Street address
Behafarin St, KarimKhanZand St, ValiAsr St, Tehran
City
Tehran
Province
Tehran
Postal code
4871115937
Phone
+98 21 8214 1000
Email
neda.kaffash@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Neda Kaffash
Street address
Science and Research Branch, Daneshgah Blvd, Simon Bulivar Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۷۷۸۹۳۸۵۵
Phone
+98 21 4486 5179
Email
neda.kaffash@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
None
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
Islamic Azad University
Full name of responsible person
Neda Kaffash
Position
Master
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
No. 48, Golestan8, AbazarBlvd, Sadeghie Sq.
City
Tehran
Province
Tehran
Postal code
1471773161
Phone
+98 21 4401 2937
Email
neda.kaffash@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Farasatinasab
Position
Assistant Professor of Clinical Pharmacy
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
, School of Pharmacy-International Campus. Kazem Besarati St. Kabiri Tameh Ave. Shahid Hemmat Expy
City
Tehran
Province
Tehran
Postal code
1471773161
Phone
+98 21 4401 2937
Email
maryfarasati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
neda kaffash
Position
Master
Latest degree
Master
Other areas of specialty/work
Medical Engineering
Street address
No.48, goldasht Ave, abazar Blvd, sadeghie Sq
City
tehran
Province
Tehran
Postal code
1471773161
Phone
+98 21 4401 2937
Email
neda.kaffash@yahoo.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
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
The results of the document is shared but the data can't be shared.
When the data will become available and for how long
The results will be shared after publication.
To whom data/document is available
The data is secret. I can't be allowed to share it.