The Effect of Local Therapy on Chest Pain in Patients with Coronary Disease
Design
This is a randomized clinical trial study, in which 78 randomly assigned random access units were divided into two parallel groups of 39 intervention and control groups. Both groups received routine care according to a cardiologist. In the intervention group, in addition to routine care, the patients received an overnight warm-up heart warm-hearth room at a temperature of 50 ° C for 20 minutes in the posterior area of the nurse for an hour after entering the hearth area. Therapy Continued for 5 days. Before the onset of intervention in the event of heart attack, the severity of the pain was determined using a numerical questionnaire (VAS), with the need for or no need for opioids to relieve pain. Also, after starting the first session of the first session, the patient's pain intensity during the 5 sessions to 12 hours after the last session was determined based on the numerical pain questionnaire, along with the number of pain, length of pain, need or lack of need for opioid analgesia. It turned out Also in the control group, the patients completed the questionnaire after receiving routine therapies (TNG).
Settings and conduct
Heart Hospital of Ahvaz Golestan Hospital
Participants/Inclusion and exclusion criteria
The presence of a definite diagnosis of acute coronary syndrome by a specialist physician. 2. Having a physiological stable status to answer questions. 3. The ability to speak and understand fully the language of Farsi. 4. Age of 30 years and above. 5. Non-alcohol and drug addiction. Musculoskeletal or gastrointestinal disease at the time of heart disease 7. No mental and psychological illness 8. No decrease in consciousness and anesthesia at the time of symptoms. 9. Non-drug addiction and use of anti-anxiety and analgesics
Intervention groups
The intervention group received topical hemotherapy
Control group without receiving heat therapy
Main outcome variables
Coronary pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161122031017N2
Registration date:2018-01-27, 1396/11/07
Registration timing:retrospective
Last update:2018-01-27, 1396/11/07
Update count:0
Registration date
2018-01-27, 1396/11/07
Registrant information
Name
Amin Moradkhani
Name of organization / entity
ahwaz jondi shapour university medical science
Country
Iran (Islamic Republic of)
Phone
+98 61 3161
Email address
moradkhani.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
2017-08-11, 1396/05/20
Actual recruitment end date
2017-10-23, 1396/08/01
Trial completion date
empty
Scientific title
The Effect of Local Therapy on Chest Pain in Patients with Acute Coronary Disease
Public title
The Effect of Therapeutic Therapy on Chest Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of a definite diagnosis of acute coronary syndrome by a specialist physician.
2. Having a physiological stable status to answer questions.
3. The ability to speak and understand fully the language of Farsi.
4. Age of 30 years and above
Exclusion criteria:
Non-alcohol and drug addiction.
Musculoskeletal or gastrointestinal disease at the time of heart disease .
No mental and psychological illness
Non-drug addiction and use of anti-anxiety and analgesics
No decrease in consciousness and anesthesia at the time of symptoms
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Actual sample size reached:
78
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly divided into two groups of 39 by random randomized quadrilateral randomization method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Type of research: A clinical trial study of the effect of topical heat therapy on chest pain in patients with coronary heart disease.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Development of Research & Technology of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz University City. Jundishapur University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2017-06-10, 1396/03/20
Ethics committee reference number
IR.AJUMS.REC.139.144
Health conditions studied
1
Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
Acute ischaemic heart disease, unspecified
Primary outcomes
1
Description
Chest pain
Timepoint
18/5000For 1 to 5 days
Method of measurement
Numerical Inventory of Pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: A group who received topical heat therapy for 5 days to check the severity of pain after the thermal therapy
Category
Treatment - Other
2
Description
Control group:receive routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Amin Morad Khani
Street address
Ahvaz Golestan Hospital, University of street .
City
Ahvaz
Province
Khouzestan
Postal code
61-35715794
Phone
+98 61 3373 8394
Email
amin1980Msc@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Shahram Braz
Street address
Ahvaz Jundishapur University of Medical Sciences. University Street
City
Ahvaz
Province
Khouzestan
Postal code
61-35715794
Phone
+98 61 3373 8394
Email
shahrambaraz@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Research of Ahvaz Jundishapur 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
Ahvaz University of Medical Sciences
Full name of responsible person
Amin Morad Khani
Position
Student Master
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University street. Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61-35715794
Phone
+98 61 3373 8394
Email
amin1980Msc@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahram Braz
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
university street. Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61-35715794
Phone
+98 916 606 6849
Email
shahrambaraz@ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amin Morad Khani
Position
Student Nursing Masters
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
University street. Ahvaz Jundishapur University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61-35715794
Phone
+98 916 704 6800
Email
amin1980MSc@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