The aim of this study is to investigate the effect of two methods of patients preparation before exercise test on anxiety level and indices of the exercise test. Inclusion criteria: be in the moderate risk for doing exercise test according to the cardiologist diagnosis; having no previous history of chronic hypertension; No previous history of anxiety disorders. Exclusion criteria: Unwillingness to stay in research; Inability to continue cooperation. The study population is the patients with cardiovascular disease that referred to exercise test unit of Emam Ali hospital of Azna city. The sample size is 55 patients in the intervention group and 55 patients in the control group. In the intervention group, patients come to exercise test unit a day before and according to the educational package, preparation is done for them. For the control group, face to face training is done half an hour before the exercise test. Finally, the effect of preparation on anxiety level and indices of exercise test will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017051333942N1
Registration date:2017-09-13, 1396/06/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-13, 1396/06/22
Registrant information
Name
Masoumeh Eslamirad
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3503
Email address
m.eslamirad@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2016-11-21, 1395/09/01
Expected recruitment end date
2017-03-18, 1395/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two preparation methods of the patients before exercise test on anxiety level and indices of exercise test
Public title
The effect of preparation of the patients on anxiety level of exercise test
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Be in the moderate risk for doing exercise test according to the cardiologist diagnosis; Having no previous history of chronic hypertension; No previous history of anxiety disorders;
Exclusion criteria: Unwillingness to stay in research; Inability to continue cooperation
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Basij Square, Sardasht
City
Arak
Postal code
3848176941
Approval date
2016-09-05, 1395/06/15
Ethics committee reference number
IR.ARAKMU.REC.1395.228
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
I20.0
ICD-10 code description
Unstable angina
Primary outcomes
1
Description
Anxiety
Timepoint
Half an hour before and immediately after exercise test.
Method of measurement
State anxiety inventory of Spielberger
Secondary outcomes
1
Description
Blood pressure
Timepoint
Half an hour before, During and immediately after exercise test.
Method of measurement
Patient monitoring
2
Description
Heart rate
Timepoint
Half an hour before, During and immediately after exercise test.
Method of measurement
Patient monitoring
3
Description
Arrhythmias
Timepoint
Half an hour before, During and immediately after exercise test.
Method of measurement
Patient monitoring
4
Description
Chest pain
Timepoint
Half an hour before, During and after exercise test.
Method of measurement
Ask the patient
5
Description
Dyspnea
Timepoint
Half an hour before, During and after exercise test.
Method of measurement
Ask the patient
6
Description
Leg muscle cramps or fatigue
Timepoint
Half an hour before, During and after exercise test.
Method of measurement
Ask the patient
Intervention groups
1
Description
Patients in the intervention group will come to the excercise unit on the previous day and according to the preparation educational package, exercise test will be explained face to face. Then training video that illustrates the stages of exercise test will be shown and then he/she will walks on the treadmill with low speed for 2 minutes.
Category
Other
2
Description
In the control group according to standard methods, the exercise test will be explained for the patient half an hour before the test.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Ali hospital of Azna
Full name of responsible person
Masoumeh Eslami Rad
Street address
Azna, Lorestan
City
Azna
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davood Hekmatpou
Street address
Basij Square, Sardasht
City
Arak
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Eslamirad
Position
M.A student of medical surgical nursing
Other areas of specialty/work
Street address
Basij Square, Sardasht
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3503
Fax
Email
nurse_rad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Davood Hekmatpou
Position
Associate Professor
Other areas of specialty/work
Street address
Basij Square, Sardasht
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3503
Fax
Email
hekmatpou@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Masoumeh Eslamirad
Position
M.A student of medical surgical nursing
Other areas of specialty/work
Street address
Basij Square, Sardasht
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3503
Fax
Email
nurse_rad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)