Determining the mean score of chest pain after percutaneous coronary intervention (PCI) in patients in the intervention and control group. Comparison of mean score of chest pain after PCI in patients in the intervention and control group.
Design
This is a randomized, double blind, controlled clinical trial with a parallel group in which 139 patients will be selected by purposeful sampling, and they are divided into two groups by block method. Random allocation software will be used to assign patients to intervention (A) and control (B) groups.
Settings and conduct
This study will be performed on patients admitted to coronary care unit of Farshchian hospital in Hamadan due to myocardial infarction who need percutaneous coronary intervention (PCI). After PCI, a warm bag with a temperature of 50°C is used for the intervention group (A) and similar bags with a temperature of 5.37°C for the control group (B). The amount of chest pain will be measured by a visual analogue scale. This is a double-blind study in which patients as well as the data collector are unaware of what is being done in groups A or B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Successful angioplasty. Having normal hemodynamic conditions. Ability to speak Persian.
Exclusion criteria: Wound and injury in the chest. History of mental illness. Addiction to alcohol and narcotics. History of gastrointestinal diseases. Occurrence of any severe complications (such as cardiac arrest, myocardial infarction, heart attack, and severe heart failure).
Intervention groups
In the intervention group, local heat therapy with the temperature of 50°C for 23 minutes in the left posterior chest, two times a day is used. In the control group, local heat therapy with the temperature of 37.5°C will be performed the same way.
Main outcome variables
The frequency and severity of chest pain will be measured by (VAS).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190920044823N1
Registration date:2019-12-05, 1398/09/14
Registration timing:registered_while_recruiting
Last update:2019-12-05, 1398/09/14
Update count:0
Registration date
2019-12-05, 1398/09/14
Registrant information
Name
Mahdi Abedini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3834 1026
Email address
m.abedini@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-01, 1398/09/10
Expected recruitment end date
2020-02-29, 1398/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Topical Heat Therapy on Chest Pain due to Percutaneous Coronary Intervention
Public title
Effect of Heat Therapy on Chest Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Successful angioplasty
Having normal hemodynamic conditions
Ability to speak Persian
Exclusion criteria:
Wound and injury in the chest
History of mental illness
Addiction to alcohol and narcotics
History of gastrointestinal diseases
Occurrence of any severe complications (such as cardiac arrest, myocardial infarction, heart attack, and severe heart failure)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
138
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be selected according to inclusion and exclusion criteria and will be randomly divided into intervention and control groups. Random allocation software will be used to assign patients to intervention (A) and control (B) groups. According to the sequence of allocation schedules, letter A or B, concealed in sequentially numbered, sealed, opaque envelopes, and kept by researcher assistance who is responsible for sampling and has no any role in collecting information.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding in the control group is done using similar pads that have a temperature of 37.5 degrees. The outcome assessor will be unaware of which patients are in the intervention or control group.
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
Vice-Chancellor for Research, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.ARAKMU.REC.1398.118
Health conditions studied
1
Description of health condition studied
Unstable angina
ICD-10 code
I20
ICD-10 code description
Angina pectoris
2
Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
Primary outcomes
1
Description
Chest pain score
Timepoint
Every 6 hours in a day will be assessed chest pain.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Mortality.
Timepoint
Six month after the start of the study.
Method of measurement
Number of deaths using checklists.
2
Description
Recurrent angioplasty.
Timepoint
Six month after the start of the study.
Method of measurement
Number of new angioplasty cases using checklists.
Intervention groups
1
Description
Intervention group:Topical heat therapy on posterior chest, is performed using a warm pad that has a temperature of 50 degrees celsius. The heat pad is made of hydrophilic silicon with dimensions of 25 x 30 cm which is covered with tarpaulin. This pad is warmed by a special device called Heater Hot pack.
Category
Treatment - Other
2
Description
Control group: Patients in the control group will receive the same pad (that has a temperature of 37.5 degrees Celsius) in the same way.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Mahdi Abedini
Street address
Shah Hosseini Street
City
Hamedan
Province
Hamadan
Postal code
6517839131
Phone
+98 81 3838 1740
Email
hcvc@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Vice-Chancellor for Research, Arak University of Medical Sciences, Basij Square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
6941738481
Phone
+98 86 3417 3638
Email
Research@arakmu.ac.ir
Web page address
https://oldvcr.arakmu.ac.ir/Portal/home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?