The aim of this study was to evaluate the effect of topical therapy on comfort and physiological parameters in patients with acute coronary syndrome.
Design
This study is a control clinical trial. Eighty patients admit to the cardiac coronary care unit who are qualify for study are randomly divide into intervention and control groups.
Settings and conduct
Numerous studies have been conducted on the efficacy of heat therapy on the comfort and physiological Indexes of patients with acute coronary syndrome who reported different results. In this study, 80 patients hospitalized in cardiac care units of hospitals affiliated to Arak University of Medical Sciences were randomly divided into control and intervention groups. To evaluate comfort and physiological parameters in the intervention group, local heat treatment will be performed at 50 ° C and in the control group will be performed local heat treatment at 37 ° C. The participant and the data collector are kept blind about which participant is in which group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. The presence of a definitive diagnosis by a specialist physician of acute coronary syndrome
2. No musculoskeletal or thoracic or gastrointestinal diseases at the time of the disease.
3. Absence of swelling, scars, scratches and redness in the chest area
4. BMI between 18/5 and 25
Exclusion criteria:
1. Hypotension
2.Cardiac arrhythmia
3. Decrease of oxygen saturation of arterial blood
Intervention groups
In the experimental group, topical heat treatment with a temperature of 50 ° C will be performed in the posterior part of the chest.
In the placebo group patients will receive topical heat therapy in the posterior part of the chest at 37 ° C.
Main outcome variables
Comfort; physiological parameters
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039711N5
Registration date:2020-03-04, 1398/12/14
Registration timing:registered_while_recruiting
Last update:2020-03-04, 1398/12/14
Update count:0
Registration date
2020-03-04, 1398/12/14
Registrant information
Name
Mohamad Golitaleb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
m.golitaleb@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-09, 1398/10/19
Expected recruitment end date
2020-07-09, 1399/04/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Local heat therapy on Comfort And Physiological parameters in the Patients with Acute Coronary Syndrome
Public title
The effect of Local heat therapy on Comfort And Physiological parameters
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of a definitive diagnosis by a specialist physician of acute coronary syndrome
No musculoskeletal or thoracic or gastrointestinal diseases at the time of the disease.
Absence of swelling, scars, scratches and redness in the chest area
BMI between 18/5 and 25
Exclusion criteria:
Hypotension
Cardiac arrhythmia
Decrease of oxygen saturation of arterial blood
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After selecting qualified samples, informed consent form is obtained. Eighty patients will be randomly assigned to either the intervention or control groups, initially 8 blocks of 10 different T and C letters (which represent the intervention and control groups). Belong to the control group). These blocks were then randomly selected to obtain an 80-fold combination of blocks, respectively. The resulting combination of letters is placed individually in 80 closed envelopes, with each patient opening one envelope in order to determine which group the patient falls into.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants will be unaware of the type of intervention. Also, the nurse will not be informed about the type of intervention. Therefore, the study will be double blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Education and Research Deputy of Arak University of Medical Sciences, Basij Square, Arak, Iran
Intervention group: In the experimental group, topical heat treatment with a temperature of 50 ° C will be performed in the posterior part of the chest.The hot pack is placed in the 4 to 11 chest area and the patient is placed in the supine position on the hot pack. The duration of the heat treatment is 23 minutes.Heat treatment is performed every 12 hours for 2 days.
Category
Other
2
Description
Control group: In the placebo group patients will receive topical heat therapy in the posterior part of the chest at 37 ° C.The hot pack is placed in the 4 to 11 chest area and the patient is placed in the supine position on the hot pack. The duration of the course is 23 minutes.Heat treatment is performed every 12 hours for 2 days.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Mohamad Golitaleb
Street address
Basij square. Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirhos/fa
2
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Mohamad Golitaleb
Street address
Amir Kabir Hospital .Nursing Square - Shiroudi Street .Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 4715
Email
info@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirkabirhos/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Education and Research Deputy of Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Web page address
http://arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Mahtab Farahani
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences. Basij square. Arak
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3503
Email
mahtabfarahanie@gmail.com
Web page address
http://arakmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad Golitaleb
Position
Associate Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Campus Site, University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
38481-7- 6941
Phone
+98 86 3417 3503
Email
mohamadgolitaleb@gmail.com
Web page address
http://www.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahtab Farahani
Position
Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Campus Site, University of Medical Sciences, Basij Square, Arak, Iran
City
Arak
Province
Markazi
Postal code
38481-7- 6941
Phone
+98 86 3417 3503
Email
mahtabfarahanie@gmail.com
Web page address
http://www.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Shared data including demographic and disease information, type and method of intervention, information about sleep quality of participants before and after intervention.
When the data will become available and for how long
Start the access period 6 months after the results are published.
To whom data/document is available
Researchers and people working in nursing education as well as nursing clinical staff.
Under which criteria data/document could be used
The data can be used for education, research and clinical nursing. The applicant must be in the nursing field The data applicant only uses data for teaching, research and clinical nursing.
From where data/document is obtainable
Mohamad golitaleb,Department of critical care nursing,school of nursing,Arak university of medical sciences
E mail:Mohamadgolitaleb@gmail.com
Tel:+989379366279
What processes are involved for a request to access data/document
After ensuring that the data applicant is in the nursing field, we will be immediately responded to the request form by email.