The aim of this study is assessment of effects of foot- bath on anxiety and physiologic parameters of patients undergoing coronary angiography in Koosar hospital of Semnan.
Inclusion criteria include admission for coronary angiography for the first time, having literacy above the sixth grade and hemodynamic stability. Exclusion criteria include history of drug abuse, history of psychiatric disorders, previous use of Foot-bath device, ulceration and contagious skin diseases in the lower extremities and dangerous arrhythmias during the intervention.
The study population are patients referred for coronary angiography and the samples consist of 92 patients that assigned in two intervention and control group randomly.
Intervention group at first complete Spielberger anxiety scale and physiologic parameters were be taken with same instruments. Then foot –bath with Foot-bath device is done for 10 minutes. Then patients complete the Spielberger anxiety scale and physiological parameters will be checked and recorded again.
Control group at first complete Spielberger Anxiety Scale and physiological parameters were be taken with same instruments. Then they rest in bed for 10 minutes and finally complete the Spielberger anxiety scale and physiological parameters will be checked and recorded again.
The primary outcome of this study is patient anxiety and secondary outcomes are blood pressure, pulse rate and o2 saturation.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072118550N1
Registration date:2014-09-29, 1393/07/07
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-09-29, 1393/07/07
Registrant information
Name
Nayyereh Raiesdana
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 3867
Email address
nr_dana@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Chancellor for research of Semnan University of Medical Sciences
Expected recruitment start date
2014-11-07, 1393/08/16
Expected recruitment end date
2015-07-07, 1394/04/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of effects of foot-bath on anxiety and physiologic parameters of patients undergoing coronary angiography at Koosar hospital in Semnan
Public title
Effect of foot-bath on anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Admission for coronary intervention for the first time,
Having full consciousness and awareness of time and place, Having literacy level above 6 grade of Hemodynamic stability, Receiving the last dose of the drug 4 hour before completing questionnaire and receiving sedatives the night before the day of angiography ,
Willingness to participate in research,
exclusion criteria: Narcotic addiction,
Having previously known mental disorder,
History of using foot bath instrument,
Interrupting or non complete intervention (due to patient noncompliance or dangerous Cardiac arrhythmia),
Having cancer, lupus, skin diseases, ulcers in the intervention site (the middle leg to the tip of the toes) ,
Having a contagious skin disease in the lower limbs
Patients is relatives or acquaintances of medical personnel
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
92
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 Semnan University of Medical Sciences
Street address
Chancellor for research of Semnan University of Medical Sciences, Boulevard Jahad, Semnan,Iran
City
Semnan
Postal code
38118-35131
Approval date
2014-08-30, 1393/06/08
Ethics committee reference number
93/490113
Health conditions studied
1
Description of health condition studied
Coronary artery angiography
ICD-10 code
179 ,178,
ICD-10 code description
Disorders of arteries, arterioles and capillaries in diseases classified elsewhere
Primary outcomes
1
Description
Anxiety
Timepoint
Before intervention, immediately after intervention and 30 minute after intervention
Method of measurement
with using standard Speilberger Anxiety Scale
Secondary outcomes
1
Description
Physiological parameter
Timepoint
before intervention, immediately after intervention and 30 minutes after intervention
Method of measurement
Tympanic termometer, Digital sphygmomanometer, Pulse-oximeter and counting respiratory rate
Intervention groups
1
Description
"Intervension group: Putting two foot of patients for 10 minutes in Foot-bath device"
Category
Other
2
Description
"Control group: Do not recieve any intervention"
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Koosar Hospital of Semnan
Full name of responsible person
Nayyereh Raiesdana
Street address
Faculty of Nursing and Allied Health, Semnan University of Medical Sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Chancellor for research of Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidipoor
Street address
Chancellor for research of Semnan University of Medical Sciences, Boulevard Jahad, Semnan, Iran
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellor for research of Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Phd-Assistant professor
Other areas of specialty/work
Street address
Faculty of Nursing and Allied Health, Semnan University of Medical sciences, 5th kilometer of Damghan road, Semnan, Iran
City
Semnan
Postal code
35131-38111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@semums.ac.ir; nr_dana@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Nursing and Allied Health,Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Phd
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
35131-38111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@semums.ac.ir; nr_dana@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Nayyereh Raiesdana
Position
Phd-Assistant professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences
City
Semnan
Postal code
35131-38111
Phone
+98 23 3365 4190
Fax
+98 23 3365 4209
Email
nr_dana@semums.ac.ir; nr_dana@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)