Determining the effect of reflex foot massage on reducing headache caused by spinal anesthesia
Design
The present study will be conducted by the method of randomized controlled clinical trial with the participation of 70 patients undergoing surgery with spinal anesthesia who are suffering from headache. The research samples will be selected by the available method and will be divided into two groups of 35 people, intervention and control, by random allocation with colored cards. This study is one-sided blind and the participants are unaware of the division of groups
Settings and conduct
In the current research, a randomized controlled clinical trial will be conducted, after obtaining ethics approval from the Ethics Committee of the Faculty of Nursing and Midwifery of Shahid Beheshti University of Medical Sciences, and also after completing a reflexology massage training course and receiving approval, the researcher will complete the course. Reflexology massage is done, then the researcher goes to the selected hospitals of Shahid Beheshti University of Medical Sciences. This research will be carried out in a blinded manner so that the patients will be unaware of the grouping of the samples
Participants/Inclusion and exclusion criteria
Inclusion criteria:Being sober, not addicted,having literacy
Exclusion criteria:Having a history of headache, unwillingness to continue participating in the study
Intervention groups
In the intervention group, foot massage will be performed on headache points for 30 minutes (15 minutes for each foot). In the control group, only a simple exfoliation massage will be performed on the soles and feet for 6 minutes (3 minutes each foot)
Main outcome variables
Headache, Systolic and Diastolic Blood Pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230130057284N1
Registration date:2023-03-02, 1401/12/11
Registration timing:registered_while_recruiting
Last update:2023-03-02, 1401/12/11
Update count:0
Registration date
2023-03-02, 1401/12/11
Registrant information
Name
Narges Mahdavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4224 7692
Email address
narges_mahdavi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-04-21, 1402/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Foot Reflexology Massage on Reducing Post Dural Puncture Headache
Public title
The Effect of Foot Reflexology Massage on Reducing Post Dural Puncture Headache
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients between 20 and 60 years of age who undergo surgery using spinal anesthesia
Being alert and aware of time and place
Being literate in reading and writing
Only one attempt has been made to access the subarachnoid space
Not receiving painkillers three hours before the intervention
Absence of addiction, due to the effect of drugs on the pain tolerance threshold of patients
Exclusion criteria:
Having a history of chronic headache
Patients with a history of underlying diseases (having hypertension, neuromuscular diseases)
Unwillingness to continue participating in the study
Clearance before 24 hours
Acute infectious diseases during the study
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method in this study will be available and randomly limited after checking the conditions of entering the study and confirming the presence of headache after spinal anesthesia by a specialist doctor. After determining the final sample size, the samples will be divided into intervention and control groups using random allocation by card lottery. The cards are prepared with the same shape and appearance, and 35 cards with white color will belong to the intervention group and 35 cards with black color will belong to the control group. The cards will be placed in a similar envelope so that the card type is not recognized. An independent research assistant, who will only be involved in randomization, will then draw a card at random
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participating patients do not know which group they belong to
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Vali Asar Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-05-24, 1401/03/03
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1401.046
Health conditions studied
1
Description of health condition studied
Post Dural Puncture Headache
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Headache Intensity Score
Timepoint
30 minutes of massage in the intervention group for two days immediately and 90 minutes after the intervention
Method of measurement
Visual Analogue Scale
2
Description
Duration of headache
Timepoint
30 minutes of massage in the intervention group for two days immediately and 90 minutes after the intervention
Method of measurement
Visual Analogue Scale
3
Description
The amount of housing received
Timepoint
In the entire duration of the intervention
Method of measurement
Housing check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, foot massage will be performed on headache points for 30 minutes (15 minutes for each foot). In the control group, only a simple exfoliation massage will be performed on the soles and feet for 6 minutes (3 minutes each foot)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish hospital
Full name of responsible person
Maryam Bazgirian
Street address
Tajirish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
sbnmf@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hosein hospital
Full name of responsible person
Maryam Tajoddin
Street address
Imam Hossein Square, Shahid Madani Street
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
sbnmf@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahnaz Ilkhani
Street address
Vali Asar Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
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
Narges Mahdavi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alzahra girls dormitory, Vali Asar Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
narges_mahdavi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahnaz Ilkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vali Asar Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
m_ilkhani@ sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Narges Mahdavi
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Alzahra girls dormitory, Vali Asar Ave
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
narges_mahdavi@sbmu.ac.ir
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
After the collection and statistical analysis, all the variables in the research can be shared and the personal information of the participants is confidential
When the data will become available and for how long
Probably the end of the year 2023
To whom data/document is available
University researchers, university professors and nursing students
Under which criteria data/document could be used
If the principles of research ethics have been observed and proceeded according to the principles
From where data/document is obtainable
Email: narges_mahdavi@sbmu.ac.ir Narges Mahdavi contact number 00989368347114
Email: m_ilkhani@sbmu.ac.ir Dr. Mahnaz Ilkhani contact number 00989123131526
What processes are involved for a request to access data/document
In this research, sampling takes about 2 months, after that one month is considered for statistical analysis and then the writing of the article begins. In total, this collection takes about 6 to 8 months