The Study of Oral Ibuprofen Effect on Pain , anxiety and Physiological Indexes in Patients Undergoing Bone marrow Biopsy in kowsar hospital from 2019 to 2020
) Comparison of the effect of oral ibuprofen on pain relief in patients undergoing bone marrow biopsy considering age, sex and body mass index
2) Comparison of the effect of oral ibuprofen on reducing anxiety in patients undergoing bone marrow biopsy considering age, sex and body mass index
3) Determining the effect of oral ibuprofen on systolic and dyastolic blood pressure , heart rate and blood oxygen in patients during and after bone marrow biopsy or aspiration
Design
Clinical trial, with control group, one-way blind, randomized
Settings and conduct
The study was performed in the oncology ward of Kowsar Hospital. In both groups, biopsy and aspiration of the bone marrow from the superior posterior iliac spine were performed. Injected. Medication was given to patients. Pain questionnaire. Anxiety was filled by the patient and physiological indicators were recorded.
Participants/Inclusion and exclusion criteria
No entry:
taking sedative drug and opioid, History of hypersensitivity reactions to non-steroidal anti-inflammatory drugs , Third trimester of pregnancy or lactation
Brain bleeding, active bleeding ,uncontrolled heart failure ، thrombocytopenia
entrance :
more than 18 years old
full satisfaction
Intervention groups
Intervention group: An hour before the procedure will receive a 400-mg oral ibuprofenic tablet
Main outcome variables
Reducing pain and anxiety Bone marrow biopsy pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181009041284N1
Registration date:2020-09-28, 1399/07/07
Registration timing:retrospective
Last update:2020-09-28, 1399/07/07
Update count:0
Registration date
2020-09-28, 1399/07/07
Registrant information
Name
Fateme Mohammadkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3346 6945
Email address
medc855@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-10, 1398/12/20
Expected recruitment end date
2020-05-14, 1399/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Study of Oral Ibuprofen Effect on Pain , anxiety and Physiological Indexes in Patients Undergoing Bone marrow Biopsy in kowsar hospital from 2019 to 2020
Public title
Effect of Oral Ibuprofen in Bone Marrow Biopsy Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction of the patient to participate in the plan
Compelete consciousness
Be in the adult age category (over 18 years old)
Exclusion criteria:
Taking sedative drug and opioid
History of asthma, urticaria, and any hypersensitivity reactions to non-steroidal anti-inflammatory drugs and aspirin
Pacemaker
Third trimester of pregnancy or lactation
Active liver disease
Brain bleeding or other active bleeding
Uncontrolled heart failure
Inflammatory bowel disease
Thrombocytopenia
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was performed by simple randomization method. Numbers from 1 to 30 were written on paper and placed in sealed envelopes. It was then distributed among the samples and patients who had even numbers in the envelope were in the intervention group and those who had odd numbers were in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients were kept blind. Because the control group was given a drug very similar to Ibuprofen.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Kosar hospital , Amin blvd, Golestan town , Semnan City
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.SEMUMS.REC.1398.293
Health conditions studied
1
Description of health condition studied
Pain and anxiety and physiological parameters during bone marrow biopsy and aspiration
ICD-10 code
D75.9
ICD-10 code description
Disease of blood and blood-forming organs, unspecified
Primary outcomes
1
Description
Pain score at visual analogue scale questionnaire
Timepoint
After the end of the procedure
Method of measurement
Visual analogue scale questionnaire
2
Description
Anxiety score at clinical Global Impression questionnaire
Timepoint
After the end of the procedure
Method of measurement
Clinical Global Impression questionnaire
3
Description
The amount of blood pressure
Timepoint
Before the intervention, the second minute, the fourth minute, the end of the intervention
Method of measurement
Mercury sphygmomanometer
4
Description
Heart rate
Timepoint
Before the intervention, the second minute, the fourth minute, the end of the intervention
Method of measurement
Cardiac monitoring device
5
Description
Percentage of blood oxygen saturation
Timepoint
Before the intervention, the second minute, the fourth minute, the end of the intervention
Method of measurement
Pulse Oximeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:One hour before the procedure, the patient receives one 400 mg ibuprofen tablet orally. The number of drugs is one and a single dose.This method of drug therapy is to reduce pain and is a non-steroidal anti-inflammatory drug and is done only once. The manufacturer is Abaidi.
Category
Treatment - Drugs
2
Description
Control group: One hour before the procedure, they receive a placebo similar to ibuprofen 400 mg tablet. This pill has no therapeutic effects and looks similar to ibuprofen. It is taken orally and once.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Kosar Hospital
Full name of responsible person
Mohammad Foroozesh Fard
Street address
Kosar Hospital , Amin Blvd, Golestan,Town , Semnan City
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7837
Email
medc855@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Bvld , Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_Kokha@yahoo.com
Web page address
http://www.semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozesh Fard
Position
Proffesor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kosar Hospital , Amin Blvd, Golestan Town , Semnan City
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 31420
Email
Mff45@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammad Foroozesh Fard
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Kosar Hospital , Amin Blvd, Golestan Town , Semnan City
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 31420
Email
Mff45@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fateme Mohammadkhani
Position
stager
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 241 , 6th Post ave , Imam ali square , Semnan town
City
Semnan
Province
Semnan
Postal code
3519753481
Phone
+98 23 3346 6945
Email
Medc855@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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 and results can be shared after the study
When the data will become available and for how long
-Will be available in December.
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Rozita Hedayati. Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 912 331 1988
What processes are involved for a request to access data/document
After making the necessary edits, these documents will be registered in the form of articles and will be available at December