The aim of this study is to investigate the effects of chest local heat therapy in the posterior of chest on chest pain and cardiovascular function in patients with acute coronary syndrome. Inclusion criteria are the existence of absolute diagnosis of acute coronary syndrome by the specialist physician and having a stable physiological condition for answering to the questions. Exclusion criterion is any type of clinical condition that requires a special diagnosis and treatment that makes local heat therapy impossible for the patient. In this study, we randomly will be allocated 50 patients with acute coronary syndrome to either the placebo or the experimental groups. Patients in the experimental and the placebo groups will be received local heat therapy in the posterior of chest using a hot pack warmed to 50 and 37 °C, respectively. Local heat therapy will be administered for four 23-minute sessions in two subsequent days. We will be assessed chest pain intensity, duration and frequency as well as the need for opioid analgesic therapy both before and after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015081312878N2
Registration date:2015-09-16, 1394/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-16, 1394/06/25
Registrant information
Name
Batol Mohammadian
Name of organization / entity
Gonabad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 53 3725 4435
Email address
mohammadian.b@gmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Gonabad University of Medical Science
Expected recruitment start date
2015-08-26, 1394/06/04
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of local heat therapy in the posterior of chest on chest paincardiovascular function in patients with acute coronary syndrome
Public title
The effect of local heat therapy on chest pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The existence of absolute diagnosis of acute coronary syndrome by the specialist physician, having a stable physiological condition for answering to questions, age range from 18 to 100, non addiction to alcohol and narcotics, having no diabetic or muscloskeletal disease of chest or digestive diseases at the time of the disease, no existence of inflammation, wound, scratching and redness in the area of chest. Exclusion criteria: Lock of tendency to participate in the study, worsening the patients condition and lack of a stable condition for answering the questions and every type of clinical condition that requires a special diagnosis and treatment that local heat therapy for the patient be impossible.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Gonabad University of Medical Sciences
Street address
Gonabad University of Medical Sciences, Next to the Asian Road, Gonabad, Iran
City
Gonabad
Postal code
Approval date
2014-10-22, 1393/07/30
Ethics committee reference number
GMU.REC.1393.75
Health conditions studied
1
Description of health condition studied
Acute coronary syndrom
ICD-10 code
I20-I25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Chest pain
Timepoint
Befor and after intervention
Method of measurement
McGill Pain Questionnaire
Secondary outcomes
1
Description
Heart rate
Timepoint
Befor and after intervention
Method of measurement
Heart rate (beats/min) will be measured with cardiac monitor
2
Description
Systolic BP
Timepoint
Befor and after intervention
Method of measurement
Systolic pressure (mmhg) will be measured with cardiac monitor
3
Description
Diastolic BP
Timepoint
Befor and after intervention
Method of measurement
Diastolic pressure (mmhg) will be measured with cardiac monitor
4
Description
O2saturation
Timepoint
Befor and after intervention
Method of measurement
Pulse oximetry
Intervention groups
1
Description
Patients in the experimental groups will be received local heat therapy in the posterior of chest using a hot pack warmed to 50°C
Category
Other
2
Description
Patients in the placebo groups will be received local heat therapy in the posterior of chest using a hot pack warmed 37 °C