Comparison of the effect of back massage by hand and hot towel on muscle pain and pulmonary function of patients undergoing open-heart surgery in the intensive care unit of selected Aja hospitals
Design
Three-group clinical trial with two intervention groups and one control group, non-blind test and randomized selection
Settings and conduct
This study will be performed on patients undergoing open-heart surgery in the intensive care unit of Shahid Doran Hospital in Shiraz in 2020-2021.
Participants/Inclusion and exclusion criteria
90 patients who met the necessary criteria for inclusion in the study, including satisfaction, not attending similar sessions, not suffering from mental retardation and alertness, and did not use drugs.
Intervention groups
Massage group: The patient will be in a comfortable position, ie sitting slightly bent forward, then stroke massage with dry and clean hands will be applied on the patient's back area on the second, third, and fourth days after the operation and for 20 minutes.
Hot towel group: The patient will be in a comfortable position, ie sitting slightly bent forward, then a towel measuring 50×50 cm with a temperature of 42 ° C on the patient's back on the second, third and fourth days after Practice and apply for 20 minutes.
Control group: will only receive routine care.
Main outcome variables
Pain intensity, pulmonary function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201203049582N1
Registration date:2021-04-21, 1400/02/01
Registration timing:registered_while_recruiting
Last update:2021-04-21, 1400/02/01
Update count:0
Registration date
2021-04-21, 1400/02/01
Registrant information
Name
Marzieh Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8609 6350
Email address
marziyehzare90@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of back massage by hand and hot towel on muscle pain and pulmonary function of patients undergoing open-heart surgery
Public title
Comparison of the effect of back massage by hand and hot towel on muscle pain and pulmonary function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The satisfaction to participate in the study
Do not use massage and hot towels for the previous three months
Do not suffer from mental retardation
No drug addiction
Having full consciousness
Ability to communicate verbally and visually
Exclusion criteria:
Bleeding less than 200 cc per hour from the chest tube
Presence of a wound or skin disease in the back
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
90 patients will be selected based on the criteria for entering the study and based on the Target-based sampling method and will be randomly assigned to three groups of massage intervention, hot towel intervention, and control (30 people in each group). In this way, patients with code one will be placed in the group of massage intervention, code two with hot towel intervention and code three with control, and will continue until number 90.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the AJA University of Medical Sciences
Street address
Tehran, West Fatemi St, Shahid Etemadzadeh St, AJA University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.AJAUMS.REC.1400.005
Health conditions studied
1
Description of health condition studied
Cardiovascular Diseases
ICD-10 code
I25.11
ICD-10 code description
Atherosclerotic heart disease of native coronary artery with angina pectoris
Primary outcomes
1
Description
Pain Intensity
Timepoint
The second, third and fourth days after surgery
Method of measurement
Visual Analog Scale (VAS)
2
Description
Pulmonary function
Timepoint
The second, third and fourth days after surgery
Method of measurement
Based on the results of incentive spirometry
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group (massage therapy intervention): The patients will be in a comfortable position, ie sitting slightly bent forward, then stroke massage with dry and clean hands will be applied on the patient's back area on the second, third and fourth days after the operation and for 20 minutes.
Category
Rehabilitation
2
Description
Intervention group: The second group (hot towel intervention):The patients will be in a comfortable position, ie sitting slightly bent forward, then a towel measuring 50×50 cm with a temperature of 42 ° C on the patient's back on the second, third and fourth days after Practice and apply for 20 minutes.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Abbas Dowran Hospital
Full name of responsible person
Marzieh Zare
Street address
in front of Barjaston St, Modares Blvd, Shiraz
City
Shiraz
Province
Fars
Postal code
9311771587
Phone
+98 71 3723 4691
Email
marziyehzare90@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mojtaba Yousefi Zeshk
Street address
West Fatemi St, Shahid Etemadzadeh St
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
dr.yousefi.md@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Marzieh Zare
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
West Fatemi St, Shahid Etemadzadeh St.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
marziyehzare90@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Fatemeh Kalroozi
Position
Associate professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
West Fatemi St, Shahid Etemadzadeh St
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
fkalroozi1385@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Marzieh zare
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
West Fatemi St, Shahid Etemadzadeh St
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8802 8350
Email
marziyehzare90@gmail.com
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