The effect of massage of limbs on postoperative pain
Design
A clinical trial with a control group, with parallel groups, double blind, randomized
Settings and conduct
Patients are divided into intervention and control groups by means of four-way blocked blocks. Patients in the intervention group will receive half an hour massage in their hands and legs before surgery and during surgery. Physician, researcher and data analyst will be blind during the study.
Participants/Inclusion and exclusion criteria
Surgical length more than two hours
Satisfaction to participate in the study
Intervention groups
Patients in need of surgery will receive half an hour massage in their legs and hands before and during surgery.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120605009948N6
Registration date:2019-04-06, 1398/01/17
Registration timing:prospective
Last update:2019-04-06, 1398/01/17
Update count:1
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Majid Montazer
Name of organization / entity
Tabriz University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 8435
Email address
montazerma@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-19, 1398/01/30
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of massage of organs on postoperative pain, A double blind randomized clinical trial with a control group
Public title
Effect of massage on pain relief
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Need more than two hours surgery
Satisfaction to participate in the study
Exclusion criteria:
History of inflammatory diseases
Taking analgesic drugs
Having nervous system diseases
Taking sedative drugs
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Investigator
Data analyser
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
In the form of quadruple blocks
The randomization unit will be individualized
Blinding (investigator's opinion)
Triple blinded
Blinding description
Doctor, researcher, and data analyst will not be present during the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Emam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
14766-51666
Approval date
2019-03-11, 1397/12/20
Ethics committee reference number
IR.TBZMED.REC.1397.1059
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
At the beginning of the study, 2, 4, 6, 12, 24 hours after the massage
Method of measurement
VAS pain intensity check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will receive massage at their hands and feet for half an hour before starting surgery. During surgery, they will receive massage for half an hour in all organs.
Category
Prevention
2
Description
Control group: No action will be taken before and during surgery for this group.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Mehdi Khanbabayi Gol
Street address
Emam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
14766-51666
Phone
+98 41 1334 1705
Email
mkhanbabayi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Azadi Ave. Tabriz University of Medical Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
14766-51666
Phone
+98 41 1334 1705
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Nursery
Street address
Thorax ward, Imam Reza Hospital, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5981764867
Phone
+98 41 3337 8435
Fax
+98 41 3336 3880
Email
montazerma@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Thorax ward, Imam Reza Hospital, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5981764867
Phone
+98 41 3337 8435
Fax
+98 41 3336 3880
Email
montazerma@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Majid Montazer
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Thorax ward, Imam Reza Hospital, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5981764867
Phone
+98 41 3337 8435
Fax
+98 41 3336 3880
Email
montazerma@tbzmed.ac.ir
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