effectiveness of the jaw relaxation on stress and variability of the physiological indicators of patients with acute coronary syndrome.
Design
64 patients were selected by simple sampling and Using Minimization software, they were divided into control and intervention groups.
Settings and conduct
The study is conducted on patients admitted to CCU in a way that the jaw relaxation technique is trained to patients in the intervention group and they are asked to practice in order to achieve the skill. The stresses and physiological indices before And measured after the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1.Age 20 and above
2.Patients with acute coronary syndrome.
3.Patients being alert to the location and time and environment surrounding them.
4.patients interested in participating in the study.
5.Patients with known psychological and anxiety disorders are not known.
6. Patients don't have drug addiction.
Exclusion criteria:
1.Unwillingness to participate in the study
2.Coincidentally in another study
Intervention groups
In the intervention group, jaw relaxation technique is performed and In control group a small touch that is different from the therapeutic touch technique, it is performed on the jaw.
Main outcome variables
Change the amount of stress
Changing physiological indicators
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190102042210N1
Registration date:2019-05-02, 1398/02/12
Registration timing:registered_while_recruiting
Last update:2019-05-02, 1398/02/12
Update count:0
Registration date
2019-05-02, 1398/02/12
Registrant information
Name
Zeinab Ghanbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3747 4439
Email address
z.ghanbari@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
study of the effectiveness of jaw relaxation on stress and changes in physiological indices in patients with acute coronary syndrome
Public title
Effect of jaw relaxation effect on stress and changes in physiological indices
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with acute coronary artery syndromes
Be alert of the patients
Lack of active mental illness
Lack of drug addiction
Exclusion criteria:
The patient's death
Take part in another study
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
patients were selected by simple sampling and Using Minimization software, they were divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are unaware of the allocation of study groups. None of the participants know that they are in the intervention group or in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Esfahan University of Medical Sciences,hezar jarib street
City
Esfahan
Province
Isfehan
Postal code
8458119381
Approval date
2018-06-20, 1397/03/30
Ethics committee reference number
IR.MUI.RESEARCH.REC.1397.376
Health conditions studied
1
Description of health condition studied
Acute coronary syndrom
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The amount of stress in Cohen's questionnaire and colleagues ' questionnaire
Timepoint
Before the intervention and immediately 10 and 30 minutes later,
Method of measurement
Cohen Stress questionnaire
2
Description
Physiological indices
Timepoint
Before the intervention and immediately 10 and 30 minutes later,
Method of measurement
mercury pressure and oxytetracycline pulse.
Secondary outcomes
empty
Intervention groups
1
Description
We measure the physiological indices and stress in the intervention group.We will train jaw calming intervention group.We ask them two times for three days and every day to use this technique.We measured the physiological indices again before and after the intervention, then 10, 30 minutes later.
Category
Behavior
2
Description
We measure the physiological indices and stress in the control group. No relaxation intervention was performed and In control group a small touch that is different from the therapeutic touch technique, it is performed on the jaw and immediately the physiological indices were evaluated and recorded.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Zeinab ghanbari
Street address
Alzahra hospital.,sofe Blvd
City
Esfahan
Province
Isfehan
Postal code
8458119381
Phone
+98 31 3747 4439
Email
zeinab.ghanbari1370@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Yousefi hojatalah
Street address
Hezar jarib Ave.,Esfahan Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
zeinab.ghanbari1370@yahoo.com
Web page address
http://www.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
30
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
Esfahan University of Medical Sciences
Full name of responsible person
Zeinab ghanbari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hezar jari Ave.,Esfahan Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
zeinab.ghanbari1370@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zeinab ghanbari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hezar jarib Ave.,Esfahan Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8458119381
Phone
+98 31 3747 4439
Email
zeinab.ghanbari1370@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zeinab ghanbari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Heza jarib Ave.,Esfahan Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
8458119381
Phone
+98 31 3747 4439
Email
z.ghanbari@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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