Evaluation of the concurrent effect of stretching exercises and caffeine tablets on reducing headache after spinal anesthesia
Design
Patient candidate for varicocele surgery or hernia repair, randomly and with using table of random number are in 4 groups and each group contain 39 individuals.
Groups; caffeine's group , stretching exercise's group , caffeine and stretching exercise's group and control's group.
Sample size 156 was determined that divided in 4 groups.
Clinical trial , single blind , with control group
Settings and conduct
patients candidate varicocele surgery or hernia repair in Shahid Modares hospital that receive spinal anesthesia with marcaine divided in groups and participants have no information about groups and receiving medication or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria
All patient between 20 to 60 years old
Candidate of varicocele surgery or hernia repair
Without caffeine allergy
Exclusion criteria
History of hypertension and cardiac disease
Intervention groups
four groups ;
First group receive oral tablet caffeine 200 mg
Second group only do stretching exercises
Third group receive oral tablet caffeine 200 mg and exercise
Fourth group (controlled group) receive Placebo tablet
Main outcome variables
Effect of caffeine on headache severity as one of the common post spinal complications.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190131042569N1
Registration date:2020-01-19, 1398/10/29
Registration timing:retrospective
Last update:2020-01-19, 1398/10/29
Update count:0
Registration date
2020-01-19, 1398/10/29
Registrant information
Name
Nima saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2641 8939
Email address
nimasaeedi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-17, 1397/12/26
Expected recruitment end date
2019-07-17, 1398/04/26
Actual recruitment start date
2019-03-17, 1397/12/26
Actual recruitment end date
2019-08-17, 1398/05/26
Trial completion date
2020-03-16, 1398/12/26
Scientific title
Comparison the effect of stretching exercises and caffeine tablets on reducing headache after spinal anesthesia
Public title
The effect of stretching exercises and caffeine tablets on headache after spinal anesthesia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patient between 20 to 60 years old
Candidate for varicocele surgery or hernia repair
Without caffeine allergy
Exclusion criteria:
History of hypertension or cardiac disease
Age
From 20 years old to 60 years old
Gender
Male
Phase
3
Groups that have been masked
Care provider
Outcome assessor
Sample size
Target sample size:
156
Actual sample size reached:
156
Randomization (investigator's opinion)
Randomized
Randomization description
Each patient who qualifies for inclusion after completing the consent form is assigned by the person in charge of this process using a random number table from 1 to 156( 1- 39 caffeine group , 40-78 stretching exercise group , 79-117 caffeine and stretching exercise group and 118 -156 control group)where the person is placed on one of the numbers and assigned to one of the 4 specified groups. (Simple randomization by individual using random number table)
Blinding (investigator's opinion)
Single blinded
Blinding description
The anesthesiologist in charge of spinal anesthesia is not aware of the patient's group (intervention or control groups), whom receive anesthesia.
and the person responsible for follow-up, patient, contact to patients and recordings data and pain levels has o information about the intervention or control group. and only one person responsible for giving the patient's drug or placebo and how to perform the stretching exercise is aware of the patient groups.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Science, Arabi Ave , Daneshjoo Blvd ,Velenjak , Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2019-03-17, 1397/12/26
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1389
Health conditions studied
1
Description of health condition studied
Post spinal headache
ICD-10 code
O89.4
ICD-10 code description
Spinal and epidural anesthesia-induced headache during the puerperium
Primary outcomes
1
Description
The effect of stretching exercises and caffeine on post spinal headache
Timepoint
every 6 h in first 48 h , 3rd day and 5th day after the procedure
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: Caffeine group(caffeine tablet 200 mg Karen Company , once a day at morning for 1 week)
Category
Prevention
2
Description
Intervention group2: Stretching exercise's group( Stretching exercise 20 minute , once a day at morning for 1 week)
Category
Prevention
3
Description
Intervention group3: Caffeine(caffeine tablet 200 mg Karen Company , once a day at morning) and Stretching exercise's group( Stretching exercise 20 minute , once a day at morning for 1 week )
Category
Prevention
4
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
Niloufar massoudi
Street address
Shahid Modares Hospital , Saadat abad boulevard
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
modarres@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Department of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ali Ziayi
Street address
Third floor, School of Medicine , near the Taleghani Hospital , Evin , Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Fax
Email
mpd@sbmu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Department of Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloufar Massoudi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Modares Hospital , Saadat abad boulevard
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
nilomassoudi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Niloufar Massoudi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Modares Hospital , Saadat abad boulevard
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
0098212204087
Fax
+98 21 2207 4101
Email
nilomassoudi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Saeedi
Position
Anesthesia assistance
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
No. 11, First East Ave., Bistochahar metri Ave., Tehran., Iran
City
Tehran
Province
Tehran
Postal code
1997778416
Phone
+98 21 2641 8939
Fax
Email
nimasaeedi7@yahoo.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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Participant data (age, pain severity and type of patient's group) are to be shared.
When the data will become available and for how long
1 year after publication
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Using data and analysis for use in academic research