Protocol summary
-
Study aim
-
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:
registered_while_recruiting
Last update:
2019-06-12, 1398/03/22
Update count:
1
-
Registration date
-
2019-04-06, 1398/01/17
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-02-19, 1397/11/30
-
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
-
Ethics committees
1
-
Ethics committee
-
-
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
Intervention groups
1
-
Description
-
Intervention group: Patients will receive massage at their hands and feet for half an hour before starting surgery(Includes all spine surgery, All Heart Surgery, all thoracic surgery, all orthopedic surgeries). 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
1
-
Sponsor
-
-
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
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